Soluble Silicates
Soluble Silicates
Soluble Silicates
SOLUBLE SILICATES
http://www.inchem.org/documents/sids/sids/SolubleSilicates.pdf
FOREWORD
INTRODUCTION
SOLUBLE SILICATES
Silicic acid, sodium salt: 1344-09-8
Silicic acid (H2SiO3), disodium salt: 6834-92-0
Silicic acid (H2SiO3), disodium salt,
pentahydrate: 10213-79-3
Silicic acid (H2SiO3), disodium salt, nonahydrate:
13517-24-3
Silicic acid, potassium salt: 1312-76-1
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SOLUBLE SILICATES
Soluble Silicates
1344-09-8
6834-92-0
10213-79-3
13517-24-3
1312-76-1
3. Sponsor Country:
Germany
Contact Point:
BMU (Bundesministerium fr Umwelt, Naturschutz und
Reaktorsicherheit)
Prof. Dr. Ulrich Schlottmann
Postfach 12 06 29
D- 53048 Bonn-Bad Godesberg
Process used
6. Sponsorship History
How was the chemical or
category brought into the
OECD HPV Chemicals
Programme?
7. Review Process Prior to the
SIAM:
by ICCA Initiative
OECD SIDS
SOLUBLE SILICATES
have been checked and validated by BUA.
9. Date of Submission:
10. Comments:
BUA
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CAS No.
1344-09-8
6834-92-0
10213-79-3
13517-24-3
1312-76-1
Chemical Name
Structural Formula
M2O y n SiO2
(M = Na or K; n = molar ratio, defining the number of moles SiO2
per mole of M2O; a molar ratio of 1 designates metasilicates, M2SiO3)
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In a mouse local lymph node assay, sodium metasilicate was not sensitising. In humans, a single case of contact
urticaria elicited by sodium silicate is reported.
Soluble silicates have been tested in a number of repeated dose studies with exposures ranging from 28 to 180
days. The NOAELs (90d) of sodium metasilicate were 227 - 237 mg/kg bw/d for rats and 260 - 284 mg/kg bw/d
for mice (highest tested dose levels, respectively). Sodium silicate had a NOAEL (180d) of 159 mg/kg bw/d for
rats (highest tested dose). In mice the LOAEL (90 d) of sodium metasilicate was 716 - 892 mg/kg bw/d with
reduction of pituitary glands weight in female mice as adverse effect. Adverse effects in rats, dogs and turkeys
were polydipsia, polyuria and soft stools, reduction of blood plasma Ca and Mg levels, and of liver Zn
concentrations, gross cortical lesions of the kidneys or increased blood plasma P and decreased Cu at doses above
1000 mg/kg bw/d.
In vitro, soluble silicates did not induce gene mutations in bacteria: sodium silicate was negative in an E. coli
reverse mutation assay and sodium metasilicate exerted no mutagenic activity in B. subtilis and S. typhimurium.
In a modern guideline study that was performed in accordance with OECD TG 473, an aqueous sodium silicate
solution (36% active ingredient) induced no chromosomal aberrations in V79 cells, both in the absence and in the
presence of metabolic activation. In vivo, sodium metasilicate did not induce chromosomal aberrations in bone
marrow cells of mice in a study performed similarly to OECD TG 475, with the restriction that no information on
the use of positive controls was available for this study. Although the reliability of this study can therefore not be
fully evaluated, the negative result is corroborated by the fact that the chemical structure does not contain
elements that raise concern for a genotoxic activity and by the negative results of genotoxicity tests with sodium
silicate. For the group of soluble silicates under review here, it is therefore concluded that there is no evidence of
a genotoxic potential.
There were no valid carcinogenicity studies available.
The available data on toxicity to reproduction are limited. In a 4-generation study, the total number of offspring
born at 79 mg/kg bw/d was reduced to 67 % and of offspring weaned to 46 % of the control, respectively. Severe
limitations of the study and intercurrent deaths, including controls, make it however difficult to draw any firm
conclusions from this study. In mice, litter size and fertility index were unaffected at sodium metasilicate
concentrations up to and including 200 mg/kg bw/d. No developmental effects were observed in mice up to and
including 200 mg/kg bw/d. In repeat dose toxicity studies with rats, mice and dogs the macroscopic and
microscopic examination of reproductive organs did not reveal treatment-related effects.
Environment
Solid crystalline silicates have discrete melting points which depend on the content of crystallisation water:
anhydrous sodium metasilicate melts at 1089 C while sodium penta- and nonahydrate melt at 72 C and 48 C,
respectively. Due to their glass nature, solid amorphous silicates do not have discrete melting points but rather
flow points. Aqueous silicate solutions have a melting point only slightly lower than that of water.
The specific gravity or density of silicate solutions depends on the concentration (solids content), the
temperature, and the silica to alkali ratio. Commercial silicate solutions have densities ranging from ca. 1.2 1.7
g/cm3 at 20 C.
The vapour pressures that have been measured for three solid sodium silicates are extremely low: 0.0103 hPa at
1175 C (MR 1.0, metasilicate), 0.0031 hPa at 1165 C (MR 2.0) and 0.0016 hPa at 1172C (MR 3.0). This
indicates that the respective pressures at ambient temperature will be unmeasurably small.
Crystalline silicates like sodium metasilicate are readily soluble in water. Amorphous silicate glasses are only
slightly attacked by water at ambient temperatures. They can be solubilised only at elevated temperature and
pressure (ca. 150 C and > 5 bar). The solutions are infinitely dilutable with water. Silicate powders obtained by
water evaporation from silicate solutions are readily soluble in water. The water solubility depends on the pH
and pH is elevated upon dissolution of soluble silicates. Above a pH of 11 - 12 stable solutions of monomeric
and polymeric silicate ions exist. Solubility rapidly decreases when the pH is lowered to 9 leading to increasing
precipitation of amorphous silica. Below pH 9 only a small proportion is present as soluble monomeric silicate
ions, the majority existing as insoluble amorphous silica gel. Soluble silicates are insoluble in alcohols, like noctanol, making determination of a log Kow not feasible.
As inorganic substances, soluble silicates are not amenable to photo- or biodegradation. Respiration of activated
sludge is not inhibited at sodium metasilicate concentrations >=100 mg/l. Continuous dosing of 25 mg sodium
silicate/l has no adverse effects on the operation of a model sewage treatment plant simultaneously fed with
easily degradable nutrients; no significant elimination occurred with >90% detected in the effluent.
Acute toxicity testing in fish, invertebrates, and algae indicate a low order of toxicity with effect concentrations
between 210 and 1700 mg/l. The following results were obtained in acute tests:
5
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Danio rerio
Danio rerio
Oncorhynchus mykiss
Leuciscus idus
Daphnia magna
Daphnia magna
Scenedesmus subspicatus
RECOMMENDATION
The chemicals in this category are currently of low priority for further work.
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SOLUBLE SILICATES
IDENTITY
1.1
Soluble silicates are produced by fusing high purity quartz sand (SiO2) and alkali carbonate (soda,
Na2CO3 or potash, K2CO3) at temperatures of 1300-1500 C. The resulting product is an amorphous
glass that can be dissolved in water to produce silicate solutions. The fusion reaction follows the
equation
M2CO3 + n SiO2 M2OnSiO2 + CO2
M = Na or K
The various products are obtained by varying the mixing ratio of the two components. They are
therefore characterised primarily by the weight ratio (WR) or molar ratio (MR), SiO2 to Na2O or
K2O, respectively. Soluble silicates are generally not distinct stoichiometric chemical substances
(with a specific chemical formula and molecular weight), but rather glasses or aqueous solutions of
glasses.
Soluble silicates used in industry are divided into two groups:
Amorphous silicates solidified as a glass from the melt (solid or lump glasses). These amorphous
glasses are essentially anhydrous and differ from ordinary glasses in that they are soluble in water at
elevated temperature and pressure leading to silicate solutions (liquid glasses). Both solid and liquid
glasses are often referred to as waterglass. Silicate solutions are defined by their density and
viscosity, which together with the silica to metal-oxide ratio defines a unique composition for the
silicate solution. By evaporation of silicate solutions, normally in the sodium form, fine powders or
granules are obtained that have a residual water content of ca. 20 %. Unlike ground lump glass,
these materials dissolve readily in water to give silicate solutions.
Crystalline silicates, exclusively in the sodium form, by controlled crystallisation of silicate
solutions. Commercial products of this type are sodium orthosilicate (MR 0.5) or sodium
metasilicate (MR 1.0). Sodium metasilicate can be prepared in anhydrous form, or with water of
crystallisation as the penta- or nonahydrate. It is readily soluble in water.
Sodium silicates
Name:
CAS number:
1344-09-8
EINECS number:
215-687-4
Molecular
formula:
Na2O nO2Si
Molecular
weight:
Molar ratio:
Synonyms:
OECD SIDS
SOLUBLE SILICATES
The formula describes tetrasodium orthosilicate
(monomer). For common silicates structural formulae
are complex: monomer, linear and planar cyclic
oligo-, and three-dimensional polysilicate anions with
sodium cations as counterions.
Structural
formula:
Sodium metasilicates
Name:
CAS number:
6834-92-0
EINECS number:
229-912-9
Molecular
formula:
Na2O3Si
Molecular
weight:
Molar ratio:
1.0
Synonyms:
Structural
formula:
Na+
O-
Na+
O-
Si
Si
ONa+
Si
O
Na+
O-
O-
Na+
O
ONa+
Name:
CAS number:
10213-79-3
EINECS number:
229-912-9
Molecular
formula:
Na2O3Si 5H2O
Molecular
weight:
Molar ratio:
1.0
Name:
CAS number:
13517-24-3
EINECS number:
229-912-9
Molecular
formula:
Na2O3Si 9H2O
Molecular
weight:
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SOLUBLE SILICATES
Molar ratio:
1.0
Potassium silicates
Name:
CAS number:
1312-76-1
EINECS number:
215-199-1
Molecular
formula:
K2O nO2Si
Molecular
weight:
Molar ratio:
Synonyms:
Structural
formula:
1.2
Impurities
Soluble silicates are very pure substances with impurities less than 1 %: The impurities stem from
the quartz sand used rather than from the potash or soda components of the fusion mixture.
Therefore, impurities of potassium silicates are similar to sodium silicates of comparable molar
ratios.
The following impurities were reported for sodium silicate lumps of MR 3.46 (Engler 1974):
Na2SO4
0.06 %
CaO
NaCl
0.06 %
MgO 0.02 %
Fe2O3
0.033 %
TiO2
Al2O3
0.097 %
0.03 %
0.019 %
In Falcone (1997) the composition range of a typical sodium silicate solution with MR 3.4 is given
(all contents in ppm):
K
20 - 50
10 - 30
Mg
5 - 20
Ti
30 - 80
Ca
1 - 80
Fe
25 - 100
Sr
1-5
Ce
<0.3 - 2
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SOLUBLE SILICATES
Ba
<1 - 5
Zr
5 - 20
Al
50 - 200
<1 - 25
<1 - 10
The following elements were found in quantities below 1 ppm: Li, V, Cr, Mn, Co, Ni, Cu, Zn, La
and Ce.
1.3
Melting point
Solid crystalline silicates have discrete melting points which depend on the content of
crystallisation water: anhydrous sodium metasilicate melts at 1089 C (Kracek 1930), while sodium
penta- and nonahydrate melt at 72 C and 48 C, respectively (Baker et al. 1933). Due to their glass
nature, solid amorphous silicates do not have discrete melting points but rather flow points. They
reversibly solidify and soften within a broad temperature range depending on their molar ratio.
Sodium silicate lumps start to soften at 550 - 670 C and reach the flow point at 730 - 870C,
potassium silicate lumps start to soften at 700 C and reach the flow point at 900C (Engler 1974).
Aqueous silicate solutions have a melting point only slightly lower than that of water.
Vapour pressure
The vapour pressures that have been measured for three solid sodium silicates are extremely low:
0.0103 hPa at 1175 C (MR 1.0, metasilicate), 0.0031 hPa at 1165 C (MR 2.0) and 0.0016 hPa at
1172C (MR 3.0). This indicates that the respective pressures at ambient temperature will be
unmeasurably small. The penta- and nonahydrates of sodium metasilicate contain significant
amounts of hydration water (pentahydrate: 43 %; nonahydrate: 57 %). In commercial silicate
solutions the water content is still higher and can reach up to 70 %. Therefore, the vapour pressures
of the solid hydrates and the solutions are expected to be significantly higher. However, this would
be governed by the high water content and reflect rather the vapour pressure of water than that of
the respective silicates. The vapour pressures of potassium silicates have not been determined, but
they are not expected to vary significantly from those determined for the respective sodium
silicates.
Solubility and stability in water
Crystalline silicates like sodium metasilicate are readily soluble in water. For example, the
solubilities for anhydrous sodium metasilicate and the pentahydrate are 210 g/l at 20 C and 610 g/l
at 30 C, respectively. These company technical data are supported by qualitative statements from
peer-reviewed handbooks. Amorphous silicate glasses are only slightly attacked by water at
ambient temperatures. They can be solubilised only at elevated temperature and pressure (ca.
150 C and > 5 bar). The solutions are infinitely dilutable with water. Silicate powders obtained by
water evaporation from silicate solutions are readily soluble in water. Amorphous silica which
precipitates when alkaline solutions are neutralized has a water solubility of 115 mg/l at 25 C and
neutral pH (Morey et al. 1964).
Upon dissolution, the soluble silicates give rise to molecular speciation (Figure 1). Depending on
both pH and concentration the respective solutions contain varying proportions of monomeric
tetrahedral ions, oligomeric linear or cyclic silicate ions (for example di- or trisilicate ions) and
polysilicate ions of three-dimensional structure (Fig. 2) which are in a dynamic equilibrium. The
degree of polymerisation of the silicate anions increases with increasing concentration and
increasing SiO2/M2O ratio of the solution. On the other hand, pH is also strongly influencing the
11
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SOLUBLE SILICATES
Category justification
Sodium and potassium silicates only differ from each other by their counterions. The basic
structural unit of soluble silicates is a tetrahedral arrangement of four oxygen atoms surrounding a
central silicon atom. Tetrahedra are linked with each other via Si-O-Si bonds resulting in an infinite
three-dimensional network where the oxygen atoms at the corners of a given tetrahedron are shared
with neighbouring tetrahedra. Not all corners in the tetrahedra are shared; the negative charge of
unshared oxygen atoms is balanced by the presence of sodium or potassium cations which are
randomly spaced in the interstices of the silicate structure (Fig. 2). The extent to which balancing
alkali ions are present in a given silicate is defined by the molar ratio SiO2/M2O (M = Na or K). The
higher the molar ratio, the less sodium or potassium ions are present in the silica network and the
less alkaline the silicates are. The various ratios determining the application properties are adjusted
by the mixing ratio of quartz (SiO2) and soda or potash, respectively. Due to the equimolar ratio
SiO2/Na20, sodium metasilicate has a regular crystalline structure. The penta- and nonahydrate
differ from anhydrous metasilicate only by their water of crystallisation. Metasilicate is readily
solubilized in water. In the solubilized form it is indistinguishable from solubilized amorphous
silicates. In addition, once in aqueous solution, all soluble silicates give rise to the same molecular
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OECD SIDS
SOLUBLE SILICATES
speciation (Fig. 1). At environmental pH values soluble silicates are present as poorly soluble
amorphous silica and soluble monomeric silicic acid.
Biological properties of solutions
Irrespective of the molecular structure and the nature of the cation all soluble silicates have the
same structural unit, the silicon-oxide tetrahedron. The biological properties of soluble silicates are
mainly governed by their intrinsic alkalinity. At a given concentration the alkalinity of silicate
solutions is inversely correlated with the ratio SiO2/M2O: the lower the ratio, the higher the
alkalinity. A clear correlation exists between oral toxicity as well as skin and eye irritation and the
molar ratio; the toxicity and irritation increasing with decreasing ratio. Soluble silicates can react
with multivalent cationic metal ions to form the corresponding insoluble metal silicate and may thus
lead to reduced bioavailability of these ions for the body or cause depletion of these ions in the
body. However, the fact that silicates are resorbed by the gastrointestinal tract as monosilicic acid
which has no complexing properties, makes the latter possibility less likely.
The soluble silicates exhibit aquatic toxicities in excess of 100 mg/l irrespective of molar ratio or
metal cation. The aquatic toxicities of the penta- and nonahydrate forms are expected to be in the
same range as those for the anhydrous disodium salt.
(amorphous silica)
Figure 1: Soluble silicate speciation. Derived from Schleyer and Blumberg (1982)
(a)
(c)
(b)
+
Na or K
Figure 2: Silicate anion structures (a), metasilicate chain (b) and amorphous silicate glass (c).
Derived from Christophliemk (1985) and Fine (1991).
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1.5
SOLUBLE SILICATES
Physicochemical Properties
Silicic acid
Test
sodium salt
CAS-No. 1344-09-8
disodium salt
CAS-No. 6834-92-0
potassium salt
CAS-No. 1312-76-1
Physical State
Crystalline anhydrous
powder
Melting Point
1089 C
72.2 C
48 C
Density
2.61 g/cm3
1200 kg/m3 (bulk density)
1.75 g/cm3
1000 kg/m3 (bulk density)
1.65 g/cm3
800 kg/m3 (bulk density)
not available
not available
not available
Vapour Pressure
The oil/water partition coefficient is not relevant, as alkali silicates are ionisable inorganic compounds.
Water Solubility
General Comments
on Water Solubility
Determination of quantitative water solubilities is not feasible. Aqueous solutions are characterised by a dynamic polymerisation/hydrolysis equilibrium of
monomeric SiO2 (aq.), oligomeric silicate ions and polysilicate ions which is strongly pH-dependant. At pH below 9 silicates are present as amorphous
silica (SiO2) whose water solubility is 115 mg/l at 25C. At pH values above 9 undissolved amorphous silica rapidly diminishes, soluble polysilicate ions
aggregate and solubility of monomeric silica increases to up to 300 mg/l.
610 g/l at 30 C
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not available
14
OECD SIDS
1.5
SOLUBLE SILICATES
Environmental Fate
Silicic acid
Test
sodium salt
CAS-No. 1344-09-8
Photodegradation
No photodegradation is to be expected.
Stability in Water
Monitoring Data
Dissolved silica from commercial soluble silicates is indistinguishable from natural dissolved silica. Of the elemental composition of the earths crust,
SiO2 makes up 59% and similar percentages are present in many sediments and soils. Thus, silicon is the second most abundant element on earth.
Compounds of silicon and oxygen are ubiquitous in the environment; they are present in inorganic matter, like minerals and soils as well as in organic
matter, like plants, animals and man. By weathering of soil, rocks and sediments and by atmospheric deposition, silica is released into surface and
ground waters from where it may be removed by precipitation and sedimentation or taken up by living organisms, especially diatoms. Dead sedimenting
diatoms also contribute significantly to sediment silica (diatomaceous earth). Silica is found in all natural waters with an average concentration of 10-20
mg SiO2/l.
Transport and
Distribution
Due to a strong dependance on pH and concentration which leads to a dynamic polymerisation-depolymerisation equilibrium with speciation into a
variety of mono-, oligo., and polymeric anions and amorphous silica, calculations on the distribution in various environmental compartments are not
feasible. The contribution of anthropogenic inputs to the occurrence in the various compartments will be negligible compared to the concentrations
contributed to by the natural silica flux.
Biodegradation
15
disodium salt
CAS-No. 6834-92-0
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potassium salt
CAS-No. 1312-76-1
OECD SIDS
1.5
SOLUBLE SILICATES
Ecotoxicity
Silicic acid
Test
sodium salt
CAS-No. 1344-09-8
disodium salt
CAS-No. 6834-92-0
Danio rerio:
LC50 (96 h) = 210 mg/l
Acute Fish
Danio rerio:
LC50 (96 h) = 1108 mg/l (MR
3.46)
Oncorhynchus mykiss:
LC50 (96 h) = 260 - 310 mg/l
(MR 3.1)
Acute Daphnid
Daphnia magna:
EC50 (48 h) = 1700 mg/l (MR
3.2)
Microorganisms
Pseudomonas putida:
EC0 (18 h) >348 mg/l (MR
3.46; not neutralized)
EC0 (18 h) >3480 mg/l (MR
3.46; neutralized)
EC0 (30 min) = 3454 mg/l
(MR 3.0)
potassium salt
CAS-No. 1312-76-1
not available
not available
Leuciscus idus:
LC50 (48 h) = >146 mg/l
(MR 4.0)
not available
not available
not available
Daphnia magna:
EC50 (24 h) = >146 mg/l
(MR 4.0)
Pseudomonas putida:
EC0 (30 min) = 1000 mg/l
Activated sludge:
EC50 (3 h) = >100 mg/l
not available
not available
not available
Alga
Scenedesmus subspicatus:
EbC50 (72 h) = 207 mg/l (MR
3.0)
ErC50 (72 h) = >345 mg/l
(MR 3.0)
not available
not available
not available
not available
Terrestrial
not available
not available
not available
not available
not available
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SOLUBLE SILICATES
sodium salt
CAS-No. 1344-09-8
potassium salt
CAS-No. 1312-76-1
not available
not available
Acute Inhalation
not available
not available
not available
not available
not available
Acute Dermal
not available
not available
not available
not available
not available
Rabbit:
Corrosive (53.5 %, MR 1.6)
Irritating (40.9 %, MR 2.0)
Corrosive (82 %, MR 2.4)
Not irritating (39 %, MR 2.8)
Not irritating (38.3 %, MR 3.3)
Not irritating (34.5 %, MR 3.4)
Rabbit:
Corrosive (moistened)
Irritating (50% solution)
Slightly irritating (10%
solution)
Rabbit:
Corrosive (moistened)
Rabbit:
Corrosive (moistened)
Rabbit:
Slightly irritating (36 %,
MR 2.0)
Moderately (33 %, MR 3.0)
Not irritating (8.8 %, MR
3.4)
Not irritating (35 %, MR
3.4)
Not irritating (7 %, MR 3.9)
Not irritating (29 %, MR
3.9)
Skin Irritation
Eye Irritation
17
disodium salt
CAS-No. 6834-92-0
not available
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not available
Rabbit:
Not irritating (8.8 %, MR
3.4)
Slightly irritating (35 %,
MR 3.4)
Not irritating (7 %, MR 3.9)
Not irritating (29 %, MR
3.9)
OECD SIDS
1.5
SOLUBLE SILICATES
sodium salt
CAS-No. 1344-09-8
disodium salt
CAS-No. 6834-92-0
potassium salt
CAS-No. 1312-76-1
Sensitization
not available
Not sensitizing
not available
not available
not available
Repeated Dose
Rat:
NOAEL (180 d): 159 mg/kg bw/d
(highest tested dose)
Rat:
NOAEL (90 d): 227 - 237 mg/kg
bw/d (highest tested dose)
not available
Mouse:
NOAEL (90 d): 260 - 284 mg/kg
bw/d (highest tested dose)
not available
not available
not available
not available
not available
not available
not available
not available
not available
Mouse (chromosomal
aberration): Negative
not available
not available
not available
Carcinogenicity
not available
not available
not available
not available
not available
Toxicity to Fertility
not available
not available
not available
Developmental Toxicity
not available
not available
not available
not available
Mouse: no significant
developmental effects up to and
including 200 mg/kg bw/d
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SOLUBLE SILICATES
2.1
The worldwide production volume is approximately 3-4 million metric tons per year (Kuhr 1998).
Production of sodium silicates and disodium metasilicates (calculated as SiO2) in Western Europe
was estimated to be 770,000 metric tons in 2000. The European consumption (including imports
and excluding exports) was ca. 890,000 metric tons SiO2. Potassium silicates were produced at
approximately 22,000 metric tons (Lauriente and Sakuma 2002). Sodium silicates are produced at
34 locations in Western Europe; 11 plants are reported for potassium silicates (Briggs 2001).
Typically, solid glasses are produced in tank furnaces or rotary kilns by fusion of quartz sand and
soda or potash at temperatures of 1100 - 1300 C. The vast majority of soluble silicates produced is
in the form of sodium silicates. The resulting lump glass is almost exclusively converted to aqueous
solutions either at 100 C and normal pressure or at 150 C in the autoclave. Concentration or
dilution with water and addition of alkali hydroxide is used to adjust the silicate solutions to the
desired properties for the wide variety of their applications. The hydrothermal production process is
less common: here silicate solutions are directly obtained from fusion of sand and sodium or
potassium hydroxide at temperatures around 200 C and under high autoclave pressure (20 bar).
Readily soluble silicate powders are usually produced by spray- or drum-drying processes from
solutions (Kuhr 1998).
The uses of alkali metal silicates are manifold and can only be illustrated by selected important
examples (Minihan and Lovell 2000; Kuhr 1998):
Raw materials for industrial products (colloidal silica, silica gel, precipitated silica,
zeolites, aluminosilicates, magnesium silicates, synthetic clays, ceramics, and
catalysts).
Detergents (fabric washing powders, dishwasher detergents, industrial cleansing
agents).
Adhesives and binders (paperboard and cardboard, coal dust briquettes, roofing tiles,
bricks and ceramics, refractory cements, plasters and mortars, foundry molds and
cores, welding rods).
Surface Coatings (TiO2 production, concrete, paints for masonry and glass surfaces,
fire-proof glass and surface coatings, spray-coating in tunnel construction and mining).
Pulp and paper manufacture (deinking and bleaching).
Water Treatment (corrosion protection).
Civil Engineering (soil sealing and stabilisation in drilling, tunnelling, and mining,
sealing of landfills, building pits, and coastline stabilisation).
Enhanced Oil Recovery (oil flow improvers).
Textile processing (bleach and dye stabiliser).
Ceramic products (liquefying agent in porcelain slips).
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SOLUBLE SILICATES
Soluble silicate usage by industry application in Western Europe for 2000 (derived
from Lauriente and Sakuma 2002)
Direct uses:
Derivatives:
Applications
SiO2 in metric
kilotons
% of total usage
188
21
136
15
Soil stabilizers
32
3.5
TiO2
29
Refractories
20
Ceramic binders
19
15
Building industry
10
Welding rods
0.5
460
50
2.2.1
Based on the data from Lauriente and Sakuma (2002) for Western Europe, the soluble silicates and
their emissions into the environment can be broken down into the different application areas. About
50 % of the combined sodium and potassium silicates production (460 ktons SiO2/year) is further
processed to derivatives. Emissions to the environment may take place during production and
processing, but no quantitative information is available. Another 10 % (ca. 80 ktons SiO2/year) go
into direct uses which result in inclusion into or onto a matrix (e.g. refractories, TiO2, ceramic
binders, welding rods, building industry). There is potential for release to the aqueous and terrestrial
environment during production, processing and use, but no emission data are available. The
remaining soluble silicates (ca. 40 % or 360 ktons SiO2/year)) are used in applications with likely
emissions into the hydro- and/or geosphere (e.g. detergents, pulp and paper, water/wastewater
treatment and soil stabilization). Detergents (188 ktons SiO2/year) and pulp and paper (136 ktons
SiO2/year) are the most important water-relevant applications and together make up about 90 % of
the soluble silicates used in these application areas. Once they reach the hydrosphere, they are
diluted and depolymerize rapidly to give molecular species indistinguishable from natural dissolved
silica (H4SiO4 or SiO2 [aq.]) in the hydrosphere. A fraction is physically removed in the sewer
system or sewage treatment plant or is retained in the process or product (e.g. pulp and paper
applications). The removal of soluble silicates in several sewage treatment plants was measured and
an average removal of 10 % determined (van Dokkum et al. 2004). The authors assume another
10 % removal from losses through sedimentation and adsorption in the sewer system before the
sewage plant. Furthermore, to determine the amount of emissions from pulp and paper applications,
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mass balances of three paper mills were made and an overall removal of 60 % was determined. This
comprises incorporation in the produced paper or pulp and removal in the subsequent sewage
treatment. From these data emissions into surface waters of 151 ktons SiO2/year from detergent
uses and 54 ktons SiO2/year for pulp and paper applications can be calculated.
The amount of soluble silicate introduced into the environment must be seen in the context of the
background input due to geochemical weathering processes of silicate minerals. For example, the
total flux of dissolved silicate transported by rivers to the sea in Western Europe is estimated to be 5
Mtons SiO2/year (van Dokkum et al. 2004). The anthropogenic contribution to this total flux is only
4 %. However, in a local situation, the contribution of anthropogenic sources may be significantly
higher: when four paper plants were analysed for their contribution to the SiO2 background
concentration of the receiving waters, a local increase of ca. 10 - 40 % was estimated (van Dokkum
et al. 2004).
2.2.2
Of the elemental composition of the earths crust, SiO2 makes up 59 % and similar percentages are
present in many sediments and soils (Jackson 1964). Silica is found in all natural waters, the
concentration in surface waters fluctuating markedly. The median values in the US were reported to
be 17 mg SiO2/l for ground waters and 14 mg SiO2/l for streams (Davis 1964). The worldwide mean
concentration in rivers is 13 mg SiO2/l (Edwards and Liss 1973). The surface layers of seawater and
lakes are very low in silica (commonly < 1 mg/l) apparently due to incorporation of Si into the
skeletons of diatoms (Hem, 1985). The biomass, including protozoans, sponges, animals and plants,
also contains soluble silica, which is an essential constituent of many biochemical processes.
Diatoms and lower plants, such as grasses, are particularly rich in silica (Schleyer and Blumberg
1982). Large deposits of diatoms sedimented over geological times (diatomaceous earth or
kieselguhr) are found on every continent.
2.2.3
Soluble silicates are inorganic substances and therefore not amenable to biodegradation. In view of
their chemical structure and inorganic nature, they are also not expected to be photodegraded. The
substances have no COD or BOD impact on effluents (CEES 2003). In a simulation test following
the OECD confirmatory test procedure, the elimination and influence of spray-dried sodium silicate
(MR 2.1) on the biological activity of a model sewage treatment plant was determined (see chapter
4.1.4). Elimination of sodium silicate in the model sewage treatment plant was only marginal; 90 100 % was detected in the effluent (Richterich 1994).
Silica is continuously removed from water by biochemical processes: diatoms, radiolarians,
silicoflagellates, and certain sponges serve as a sink for silicon by incorporating it into their shells
and skeletons as amorphous biogenic silica, frequently referred to as opal (SiO2nH2O). They can
deplete dissolved silica in surface waters to less than 1 mg/l during blooms (Edwards 1973).
2.3
Human exposure
2.3.1
Occupational exposure
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Consumer exposure
Consumer exposure may occur primarily by contact with laundry or automatic dishwashing
detergents. The concentrations of soluble silicates typically range from 0.1 - 10 % in laundry and
from 2 - 25 % in dishwashing detergents with maximum concentrations of 25 % and 45 %,
respectively (HERA, in preparation). Information from national product registers (see Appendix 1)
indicates that higher concentrations may be present in some consumer products. However, the very
broad concentration ranges and descriptions of product groups in conjunction with missing
indications whether the data refer to consumer or industrial products make it difficult to evaluate the
information. Short-term exposure to dust may occur by the use of products in powder form only,
other application forms, like tablets or liquids being of no concern for the inhalation route.
Generally, the average particle size in powder detergents is far in excess of respirability, since the
silicates in powder form used in consumer products are sieved to retain only non-respirable
particles. In addition consumer detergents are specifically formulated to form non-dusting powders:
in a process called agglomeration the various dry ingredients are combined into single granular
particles through the binding power of liquid silicate leading to particle sizes from 230 to
1500 microns or higher (PQ Corp. undated). Alternatively, they are provided in the form of tablets
sealed by individual package allowing only limited short-term exposure. The hazard is addressed by
appropriate labelling on the consumer product.
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A risk assessment taking into account all possible routes of consumer exposure through the use of
detergents and cleaners has been performed under the HERA project (HERA, in preparation). The
cumulative systemic exposure through oral, dermal and inhalative contact was estimated to be
12.3 g soluble silicates/kg bw/d, which is about 1 - 2 orders of magnitude lower than the estimated
daily silica intake through ubiquitous natural occurrence in the diet (see below). Another route of
exposure is ingestion of drinking water, as sodium silicate may be added to drinking water as a
corrosion inhibitor and sequestering agent. According to European Standard EN 1209, the
maximum permissible concentration is 15 mg/l (European Committee for Standardization 1997).
2.3.3
Background exposure via the environment can be expected, as compounds of silicon and oxygen
are the primary constituents of earths landmasses, and an important compound in the biomass.
Dissolved silica is also a minor but widespread solute in the earths surface waters. Silicon
compounds are present in plants and animal or human organs, tissues, blood and serum (Carlisle
1986).
Silicon is a ubiquitous constituent of foods. The average daily intake of silicon is in the range of
20 - 50 mg total Si/d (corresponding to 43 - 107 mg SiO2/d). The estimated adult silicon intake via
diets in the United States of 0.32 mg Si/kg bw/d (corresponding to 0.68 mg SiO2/kg bw/d) in
females and 0.53 mg Si/kg bw/d (corresponding to 1.13 mg SiO2/kg bw/d) in males can be viewed
as representative for the intake in the Western world (Pennington 1991). While the highest
concentrations of total silicon are found in seafood, eggs and dairy products; the main dietary
sources are cereals and beverages.
Exposure to silicate solutions means exposure to silica in the form of its various silicate anions on
the one hand and alkalinity on the other hand. Both distribution of the various silicate anion species
and alkalinity depend on the silica to alkali-oxide ratio and the concentration of a given solution. It
is not possible to attribute any observed toxicity of a silicate solution to either silicate, alkalinity or
a combination of both. However, the observed toxicological symptoms are indicative of effects due
to high alkalinity. Toxicity tests executed with the dissolved pentahydrate or nonahydrate forms of
the disodium salt of silicic acid (CAS no. 10213-79-3 and 13517-24-3, respectively) are directly
applicable to the anhydrous form (CAS no. 6834-92-0) and vice versa, as they all have the same
molar ratio. Furthermore, results obtained with sodium silicate can be extrapolated to potassium
silicates of the same molar ratio, the nature of the alkali ion having no effect on the biological
properties (Schleyer and Blumberg 1982; Falcone 1997; Kuhr 1998).
3.1
Silicon is an essential trace element participating in the normal metabolism of higher animals. It is
required in bone, cartilage and connective tissue formation as well as participating in other
important metabolic processes. The silicon is present almost entirely as free soluble monosilicic
acid (Carlisle 1986). No reliable toxicokinetic, metabolic or mechanistic studies are available for
soluble silicates. Since concentrated silicate solutions are only stable at pH values above 11.5 and
lowering the pH below 11.5 leads to the formation of an insoluble silica gel (cf. Figure 2), it can be
reasonably assumed that after ingestion gel formation will be induced by the hydrochloric acid of
the stomach. The degree of gel formation will depend on the amount of ingested silicate solution
and the neutralising and buffering capacity of the gastrointestinal tract. Thus, a sodium silicate
solution of molar ratio 3 would lead to precipitation of silica according to the following equation:
23
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Acute toxicity
3.2.1
Oral toxicity
Animal data
The results of the most relevant acute oral toxicity studies are summarised in Table 2. Only the
studies by Spanjers and Til are performed under conditions comparable to OECD guidelines.
Sodium silicates and metasilicates
Sodium silicates of varying molar ratios from 0.5 to 3.38 have been tested in rats. Toxicity
decreased with increasing molar ratio: from LD50 of 500 mg/kg bw for molar ratio 0.5 to
8650 mg/kg bw for 3.38. This shows the inverse correlation between MR and toxicity. The majority
of the test results are cited as secondary literature only (Schleyer and Blumberg 1982), but several
study reports are available, albeit in limited detail (Potokar 1982; Gloxhuber and Potokar 1971a and
b; Gloxhuber et al. 1973; Saiwai 1980; Spanjers and Til 1981a, b). Clinical symptoms observed
near to or exceeding the LD50 values (Saiwai 1980) consisted of apathy, staggering gait, dyspnoea,
piloerection, abdominal discomfort, and unconsciousness. The results of autopsy revealed acute
gastro-enteritis, vascular congestion, mottled livers, changes in pH of body fluids, shock, chemical
irritation and/or corrosion of the viscera. All symptoms are indicative of effects due to high
alkalinity.
Potassium silicates
One study with rats assesses the acute oral toxicity of a potassium silicate (molar ratio 2.25)
(Spanjers and Til 1981c). The LD50-value was 5700 mg/kg bw. All clinical effects: sedation, signs
of abdominal discomfort, sluggishness and unconsciousness, were reversible. No treatment-related
gross alterations were found at autopsy.
Human data
Ingestion of 200 ml of sodium silicate egg preserving solution (they have typically a molar ratio of
3.2 and concentrations in the range of 5 - 36 %) caused severe vomiting, diarrhea and bleeding,
elevated blood pressure, and renal damage, but was not fatal (Schleyer and Blumberg 1982).
Ingestion of 500 ml of an egg-preserving solution containing sodium silicate in suicidal intention
led to the death of a 68 year old woman within 1 hour by suffocation. Aspiration of the vomited
silicate solution caused obstruction of the lungs by precipitation of amorphous silica. The
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transformation of sodium silicate from liquid to solid occurred in the lungs by means of the
carbonic acid of expiration air (Sigrist and Flury 1985).
Conclusion
The acute oral toxicity of soluble silicates is generally inversely correlated to the molar ratio
SiO2/Na2O. Toxicity decreases in rats with increasing molar ratio from LD50 of 500 mg/kg bw for
molar ratio 0.5 to 8650 mg/kg bw for 3.38. The one solitary study on potassium silicate fits well
into the toxicity pattern of the sodium silicates.
Table 2: Results of acute oral toxicity studies
Silicate
(molar ratio
SiO2/M2O)
2.25e
Na/K
K
Concentration
(wt. %)
LD50 (mg/kg
bw)
Species
Reference
5700
Rat
Na
35
8650
Rat
3.35a
Na
6600
Mouse
Gloxhuber 1973
3.3
Na
36
3200
Rat
Na
> 2000
Rat
Potokar 1982
Na
5150
Rat
Na
1600, 8600
Rat
3.38
3.3
3.27
3.1
2.1
Na
1300, 2100
Rat
2.1
Na
81
1500 - 2200
Rat
2.0f
Na
3400
Rat
1.7
Na
51
2000, 2500
Rat
1750
Rat
1.0
Na
98
1.0
Na
99
600
Rat
1.0
Na
50
800
Rat
1.0
Na
20
1152 - 1349
Rat
Saiwai 1980 *
1.0
Na
10
770 - 820
Mouse
Saiwai 1980 *
0.7
Na
61
1000, 1500
Rat
0.5
Na
90
500
Rat
*
a
b
c
d
e
f
3.2.2
No data are available on acute inhalation and dermal toxicity of soluble silicates. In view of the
irritating or corrosive properties of undiluted, concentrated soluble silicates (cf. Section 3.3) which
would result in severe local effects, studies on inhalation or dermal toxicity are neither feasible nor
justifiable as far as animal welfare considerations are concerned. In addition, as outlined in Section
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3.6.2, physico-chemical properties would cause technical problems preventing the generation of
precise and appropriate doses in inhalation studies.
3.3
Skin irritation
Animal data
Several primary skin irritation studies have been performed in rabbits (presented in Table 3),
including studies by Cuthbert and Carr (1985), ECETOC (1995), Heisler (1990a, b), Heisler (1993a,
b), Karlsson and Loden (1984) and Mercier (1990a, b) performed in compliance with or under
similar conditions as the relevant OECD guidelines.
Sodium silicates and metasilicates
The degree of irritation caused in the studies, indicate that the irritation response is inversely
correlated with the molar ratio of the silicates; a lower molar ratio SiO2 : Na2O leads to a higher
irritation score and vice versa. This correlation is superimposed by the concentration effect: lower
concentrations will exhibit lower irritancy as compared to higher concentrations of the same molar
ratio. The inverse correlation with molar ratio is demonstrated by the studies of Cuthbert and Carr
(1985) where sodium silicates of comparable concentrations (38 - 41 %) but different molar ratios
were tested. Whereas ratios of 2.0 and 2.4 exhibited irritating properties, ratios of 2.8 and 3.3 were
not irritating. The concentration effect becomes evident when the irritancy of identical molar ratios
but different concentrations are compared. A sodium silicate of MR 2.4 is irritating at 40 % and
corrosive at 82 % (Cuthbert and Carr 1985; Karlsson and Loden 1984); sodium metasilicate is
irritating at 10 % and corrosive at 50 % (ECETOC 1995). Sodium silicates of molar ratios 1.6 and
below and concentrations greater than 50 % are corrosive. Sodium metasilicate, when tested as an
anhydrous powder was not irritating to the skin; when moistened with water it was found to be
corrosive (Mercier 1990a, b).
Potassium silicates
The limited studies available for potassium silicates are in line with the inverse correlation of skin
effects and molar ratio that is observed for sodium silicates. Likewise, higher concentrations of the
same molar ratio are expected to exhibit higher irritating potential. As observed with sodium
silicates, potassium silicates of comparable concentrations and different molar ratios show the same
inverse correlation to irritancy. Molar ratios of 2.0 and 3.0 and 33 - 36 % concentrations were
irritating to the skin (Cuthbert and Carr 1985), whereas MR 3.4 and 3.9 (29 - 35 %) showed no
irritation (Heisler 1990a, b; Heisler 1993a, b). The results indicate that the counterions of soluble
silicates have no influence on skin irritation.
Human data
In an open epicutaneous test performed according to COLIPA, volunteers were exposed to 5, 10 or
50 % aqueous solutions or undiluted sodium silicate solution (MR 3.45) for 30 minutes (Kremer,
1997a). The light redness experienced by 2 - 3 of the 20 volunteers in each group tested with an
aqueous solution disappeared within 20 minutes. The wax-like undiluted solution did not cause
adverse effects. Under semi-occlusive (but otherwise identical) conditions, both a 50 % aqueous
solution and undiluted solution resulted in peeling of the skin in a third of the subjects after 4 hrs
exposure (Kremer 1997b). The study corresponded to OECD 404, with adjustments for human
subjects. Both studies were performed under Good Clinical Practice.
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Conclusion
Sodium and potassium silicates can be irritating to corrosive to the skin of rabbits, depending on
their molar ratio and concentration. The nature of the counterion (Na+ or K+) has no influence as
sodium and potassium silicates behave similarly with respect to skin irritation. Any effects on the
skin decrease with increasing molar ratio, superimposed by increasing irritancy with increasing
concentrations.
Table 3: Results of acute skin irritation studies
Silicate (MR
SiO2 / M2O)
Na /
K
Concentration
(wt. %)
Result / PII 1
Conclusion
Method
Reference
3.3
Na
38.3
0.33
2.8
Na
39
OECD 404,
1981
Cuthbert and
Carr 1985
2.4
Na
39.9
2.0
Na
40.9
Na
0.4
4.6
OECD 404,
1981
Karlsson and
Loden 1984
7.8
5.1
4.67
Mercier 1990a
0.17
OECD 404,
1981
1.0
1.0 (5 aq)
Na
NR
NR
1.0 (9 aq)
Na
NR
3.4
Na
34.5
3
2.4
Na
82
1.6
Na
53.5
1.0 (5 aq)
1.0
1.0
Na
Na
Na
57.5
97
83
Mercier 1990b
1.0
Na
100
1.0
Na
50
3.67
I-C
10
1.22
33
36
29
0.25
3.9
Heisler 1990a
3.4
35
0.17
Heisler 1993b
3.4
8.8
Heisler 1993a
1.0
3.0
2.0
3.9
C
I
NR
1
2
3
4
27
OECD 404
ECETOC 1995
OECD 404,
1981
Cuthbert and
Carr 1985
OECD 404
Heisler 1990b
Not irritating
Corrosive
Irritating
Not reported
Primary Irritation Index
Sodium silicate powder, moistened before application to the skin. Application of dry powder did not cause
irritation.
Sodium metasilicate powder was applied dry to the skin.
Sodium silicate powder, applied as an 83 % aqueous paste
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3.4
SOLUBLE SILICATES
Ocular irritation
Several in vivo and in vitro eye irritation studies have been performed in rabbits, of which only the
studies by Heisler (1990c, d; 1993c, d) with potassium silicates were performed according to OECD
guidelines. The results are presented in Table 4.
Sodium silicates and metasilicates
A series of non-validated in vitro studies indicate the same inverse correlation between molar ratio
and irritation that has been observed for skin irritation (York et al. 1994; Wilson and Hartop 1993;
Wilson and Lea 1994). The powders of varying molar ratios exhibited effects in enucleated rabbit
eyes ranging from corrosive (MR 1.0) to severely irritating (MR 2.0, 2.4 and 2.6) to slightly
irritating (MR 2.8, 3.0 and 3.3). As these results originate from non-validated test systems, their
reliability is uncertain.
Potassium silicates
Potassium silicates have been tested on the rabbit eye at molar ratios of 3.4 and 3.9. At
concentrations of 35 % or lower they are not or only slightly irritating (Heisler 1990c, d; Heisler
1993c, d).
Conclusion
At concentrations of 35 % and 29 % (highest tested concentrations) potassium silicates with molar
ratios of 3.4 and 3.9 were only slightly, and not irritating to the eyes of rabbits, respectively. Results
from non-validated in vitro assays indicate that the severity of eye effects is inversely correlated
with the molar ratio, with corrosive effects found in the enucleated rabbit eye test after exposure to
disodium silicate powder with a molar ratio of 1.0.
Table 4: Results of acute eye irritation studies
Silicate
(MR SiO2 /
M2O)
Na /
K
Concentration
(wt.%)
Result
Method
Reference
3.31
Na
Powder3
Slightly irritating
In vitro enucleated
rabbit eye irritation
study2
(non-validated test
system)
York et al.
1994; Wilson
and Hartop
1993; Wilson
and Lea 1994
OECD 405
Heisler, 1990d
3.0
Slightly irritating
2.8
Moderately irritating
2.6
Moderately/ severely
irritating
2.41
Severely irritating
Severely irritating
2.0
1.0
3.9
1
2
3
corrosive
29
Not irritating
3.9
Not irritating
Heisler, 1990c
3.4
35
Slightly irritating
Heisler, 1993d
3.4
8.8
Not irritating
Heisler,1993c
not reported
not specified in report whether it is a molar or weight ratio
1 minute exposure to the test substance, except for MR 1.0 where exposure was only for 10 sec.
50 mg water-soluble powder of dried silicate solution applied. Dried silicate solutions usually contain about 20 %
residual water.
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3.5
SOLUBLE SILICATES
Sensitization
Skin
Sodium silicates and metasilicates
Karrow et al. (2002) tested the sensitisation potential in the local lymph node assay. Sodium
metasilicate did not exhibit a significant effect on cell proliferation in the auricular lymph nodes of
mice after sensitisation with 2, 4, and 6 % metasilicate for 3 consecutive days.
Human data
Tanaka et al. (1982) describe a 57-year-old worker, who had suffered recurrent ulcerative lesions on
his left hand for two years, after repeated occupational exposure to 20 % aqueous sodium silicate. In
a 24-hour patch test with 20 % sodium silicate (MR unspecified) ulcer formation could be elicited
in the patient, but not in 30 healthy volunteers. An immediate wheal formation was observed in the
patient 15 minutes after a scratch test was performed with 20 % metasilicate, whereas 30 control
subjects did not show wheal formation.
Potassium silicates
No data available.
Respiratory Tract
Sodium metasilicate is nominated to the National Toxicology Program for Respiratory Sensitisation
Testing (Federal Register, 2002). The technical limitations of the realisation of such an experiment
are discussed in chapter 3.6.2.
Conclusion
Sodium metasilicate was not sensitising in the local lymph node assay. In a case study contact
urticaria induced by sodium silicate was observed.
3.6
3.6.1
Oral toxicity
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controls were registered, but these were small (6 % or less), not consistent and not dose related. No
mortalities were observed. After 180 days exposure, the male rats were used in a nitrogen and
phosphorous retention study during a total of 17 days. Phosphorus retention was somewhat
increased in the high dose group (approximately 12 %), while in the low dose group no effect of
treatment was seen. Nitrogen retention was 50 % of controls in the lower dose group only.
Ito et al. (1975) conducted a 3-month toxicity study in rats (5/sex/group) with sodium metasilicate,
administered via drinking water in concentrations of 200, 600 and 1800 mg/l (corresponding to
approximately 26.4, 76.2 and 227.1 mg/kg bw/d for males and approximately 32.1, 97.6 and
237.2 mg/kg bw/d for females.). The study conditions were similar to OECD guideline 408. No
clearly treatment related effects were found.
In a 3-month feeding study reported by Saiwai et al. (1980), 10 mice/sex/dose were exposed to
sodium metasilicate in the drinking water at concentrations of 300, 900 and 2700 ppm (males) and
333, 1000 and 3000 (females). This corresponds to 96 - 100, 264 - 280 and 776 - 832 mg/kg bwl/d
for males and 88 - 104, 260 - 284 and 716 - 892 mg/kg bw/d for females. Parameters examined
were body weight, urinalysis, clinical chemistry, haematology, organ weights, and histopathology.
No fatalities occurred. In females a significant decrease in pituitary glands weight was observed in
the highest dose group. Other effects occasionally observed were single incidences and not doserelated.
Kayongo-Male and Jia (1999) studied the effect of various Silicon sources added to diets of rats and
turkeys. Rats were exposed for 8 weeks to sodium metasilicate, pentahydrate at 500 ppm Si
(corresponding to 1259 mg metasilicate/kg bw/d). Parameters examined were body weight, organ
weight (liver and heart), hemoglobin, hematocrit, and mineral concentrations in blood plasma and
organ tissues (liver and heart). No effects on body and organ weights were observed, whereas
plasma Ca and Mg and liver Zn were reduced significantly. Turkeys exposed to 270 ppm Si
(corresponding to 2039 ppm sodium metasilicate, pentahydrate,) for 4 weeks in a similar
experiment did not exhibit significant effects on body and organ weights. Plasma P was increased
and Cu was decreased. Minerals in heart and liver tissue were unaffected.
Potassium silicates
No studies are available for potassium silicates.
Table 5:
Species
Exposure
Period
Rat
Effects
Reference
4 weeks
Newberne and
Wilson (1970)
Rat
180 days
No treatment-related effects1.
Rat
3 months
No treatment-related effects.
Sodium metasilicate 26.4,
76.2 and 227.1 mg/kg bw/d
(males) and 32.1; 97.6 and
237.2 mg/kg bw/d (females)
via drinking water
Rat
8 weeks
Sodium metasilicate,
pentahydrate 1259 mg/kg
bw/d via the diet
Kayongo-Male and
Jia (1999)
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Table 5 (cont.):
SOLUBLE SILICATES
Repeated dose toxicity of soluble silicates
Species
Exposure
Period
Mouse
3 months
Sodium metasilicate
Females showed reduced
Saiwai et al. (1980)
96-100, 264 - 280 and 776 - pituitary glands weight at 716 832 mg/kg bw/d (males)
892 mg/kg bw/d. No other doseand 88 - 104, 260 - 284 and related effects.
716 - 892 mg/kg bw/d
(females) via drinking
water
Dog
4 weeks
Newberne and
Wilson (1970)
Turkey
4 weeks
Sodium metasilicate,
pentahydrate
2039 ppm in the diet
Kayongo-Male and
Jia (1999)
Effects
Reference
body weight , mortality and nitrogen/phosphorus excretion were only parameters monitored.
a limited number of parameters was monitored: body, liver and heart weight, hemoglobin, hematocrit and mineral
concentrations in blood plasma and livers and hearts.
Conclusion
Repeated dose toxicity studies with sodium silicate or sodium metasilicate ranging from 4 weeks to
180 days have been conducted with rats, mice, dogs and turkeys. The only treatment-related effects
observed in rats were:
polydipsia, polyuria and soft stools at 2400 mg/kg bw/d (sodium silicate of unspecified
MR; 4 weeks exposure).
Reduction of blood plasma Ca and Mg and liver Zn concentrations at 1259 mg/kg bw/d
(sodium metasilicate, pentahydrate; 8 weeks exposure).
In female mice, a reduced pituitary glands weight was observed at 716 - 892 mg/kg bw/d (sodium
metasilicate; 3 months exposure). Dogs exhibited gross cortical lesions of the kidneys, polydipsia,
polyuria and soft feces at 2400 mg/kg bw/d (sodium silicate of unspecified MR; 4 weeks exposure).
In turkeys, blood plasma P was increased and Cu decreased at 2039 mg/kg diet (sodium
metasilicate, pentahydrate; 8 weeks exposure).
From these studies a NOAEL (90 d) of 227 - 237 mg/kg bw/d can be derived for rats. The NOAEL
(90 d) for mice is 260 - 284 mg/kg bw/d.
3.6.2
No repeated dose animal studies on the inhalation and dermal toxicity of silicates are available.
Sodium metasilicate has been nominated to the National Toxicology Program (NTP) for
Toxicological Studies in the United States. A subchronic inhalation study was recommended by the
National Institute for Occupational Safety and Health (Federal Register 2002). At present, the
technical feasibility and practical relevance of such a study is under discussion with the following
points to consider:
First, commercial sodium metasilicates are sieved to contain only large non-respirable particles of
> 200 m in granular products, or > 50 m in powders (Minihan and Lovell 2000; Rhodia 2003 and
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2001; Cognis 2003), i.e. the commercial products are non-respirable. For the inhalation assay
grinding to a fine and respirable powder would be required, representing a test substance which is
not existing under real life conditions.
Second, due to the hygroscopic properties and the ready solubility in water, the majority of
particles, if inhaled, will be retained and dissolved by mucus in the upper respiratory tract. Thus,
effects would be restricted to local corrosive/irritant effects, due to the intrinsic alkalinity of sodium
metasilicate. Furthermore, acidification to pH below 11 or 12 leads to precipitation of sodium
metasilicate and transformation into amorphous silica. Amorphous silica has already been
investigated and toxicological properties, including inhalation toxicity, are available on this
compound.
Third, because of its hygroscopic properties, anhydrous sodium metasilicate tends to aggregate in
the presence of moisture, and this limits further the technical realisation of such a study without
specific conditions to maintain a dry atmosphere.
3.7
Genetic toxicity
3.7.1
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ingredient) induced no chromosomal aberrations in V79 cells, both in the absence and in the
presence of metabolic activation.
3.7.2
Carcinogenicity
3.9.1
Effects on fertility
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Severe limitations of the study and intercurrent deaths, including controls, make it difficult to draw
any firm conclusions from this study.
Potassium silicates
No data are available.
3.9.2
Developmental toxicity
Other studies
In a study by Kamboj and Kar (1964), male rats were injected subcutaneously and intratesticularly
with doses of 0.08 mmole/kg sodium silicate (MR not specified). When the testes were examined
7 d after injection, no morphological or histological effects were seen in either application route nor
was there any effect on residual spermatozoa in the ductus deferens. Testicular weight was slightly
reduced as compared to controls injected with sterile water.
Some of the available subchronic/chronic repeat dose studies (cf. 3.6.1) shed also light on the
effects of sodium silicates on the reproductive organs:
In the 3-month study performed by Sawai et al. (1980) with mice, exposure via drinking water to
metasilicate concentrations up to and including 832 and 892 mg/kg bw/d for males and females,
respectively, did not show treatment-related effects on the pathohistology of testes and ovaries. The
mean wet weight of these organs was also not affected (testes: 0.13 - 0.14 g for control; 0.12 - 0.14
g for dosage groups; ovaries: 7.3 - 8.4 g for control; 7.4 - 9.7 g for dosage groups).
No effects on the male and female reproductive organs were observed upon macroscopic and
microscopic examination when rats were exposed to 200, 600 and 1800 ppm in drinking water (26,
76 and 227 mg/kg bw/d for males; 32, 98 and 237 mg/kg bw/d for females) for 3 months (Ito et al.
1975).
Rats and beagle dogs were exposed to sodium silicate of unknown molar ratio for 4 weeks at a
single concentration of 2400 mg/kg bw/d via the diet. According to the authors, a complete
necropsy and histopathological study was performed and no treatment-related effects except in the
kidneys observed (Newberne and Wilson 1970).
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Conclusion
The available data on toxicity to reproduction are limited. In a 4-generation study, the total number
of offspring born at 79 mg/kg bw/d was reduced to 67 % and of offspring weaned to 46 % of the
control, respectively. Severe limitations of the study and intercurrent deaths, including controls,
make it however difficult to draw any firm conclusion from this study. In mice, litter size and
fertility index were unaffected at sodium metasilicate concentrations up to and including 200 mg/kg
bw/d. No developmental effects were observed in this study up to and including 200 mg/kg bw/d. In
repeat dose toxicity studies with rats, mice and dogs the macroscopic and microscopic examination
of reproductive organs did not reveal treatment-related effects. In view of the limited data on
reproduction and developmental toxicity further studies would be desirable. However, the irritating
or corrosive properties of undiluted, concentrated soluble silicates (cf. Section 3.3) would result in
severe local effects and are therefore neither feasible nor justifiable with respect to animal welfare.
Dilution of the test material to avoid corrosive effects would make it difficult to administer high
doses whereas neutralisation would lead to precipitation of SiO2 thus altering the chemical identity
of the test substance.
3.10
The limited toxicokinetic studies on rats, cats, dogs and guinea pigs all showed that the excretion of
silicon with the urine was markedly increased after ingestion of silicates. The excretion rate was
independent of the doses applied indicating that the limiting factor is the rate of production of
soluble or absorbable silicon in the gastrointestinal tract.
The oral LD50 in rats was 1152 5700 mg/kg bw depending on the molar ratio of the silicate
species, i.e. toxicity decreases with increasing molar SiO2:MeO2 ratio. Clinical signs included
apathy, staggering gait, tonic cramps, dyspnoea, cyanosis, piloerection and signs of abdominal
discomfort.
Sodium and potassium silicates can be irritating to corrosive to the skin of rabbits, depending on
their molar ratio and concentration. The nature of the counterion (Na+ or K+) has no influence as
sodium and potassium silicates behave similarly with respect to skin irritation. Any effects on the
skin decrease with increasing molar ratio, superimposed by increasing irritancy with increasing
concentrations. At concentrations of 35 % and 29 % (highest tested concentrations) potassium
silicates with molar ratios of 3.4 and 3.9 were only slightly, and not irritating to the eyes of rabbits,
respectively. Results from non-validated in vitro assays indicate that the severity of eye effects is
inversely correlated with the molar ratio, with corrosive effects found in the enucleated rabbit eye
test after exposure to disodium silicate powder with a molar ratio of 1.0.
In a mouse local lymph node assay, sodium metasilicate was not sensitising. In humans, a single
case of contact urticaria elicited by sodium silicate is reported.
Soluble silicates have been tested in a number of repeated dose studies with exposures ranging from
28 to 180 days. The NOAELs (90 d) of sodium metasilicate were 227 - 237 mg/kg bw/d for rats and
260 - 284 mg/kg bw/d for mice (highest tested dose levels, respectively). Sodium silicate had a
NOAEL (180 d) of 159 mg/kg bw/d for rats (highest tested dose). In mice the LOAEL (90 d) of
sodium metasilicate was 716 - 892 mg/kg bw/d with reduction of pituitary glands weight in female
mice as adverse effect. Adverse effects in rats, dogs and turkeys were polydipsia, polyuria and soft
stools, reduction of blood plasma Ca and Mg levels, and of liver Zn concentrations, gross cortical
lesions of the kidneys or increased blood plasma P and decreased Cu at doses above 1000 mg/kg
bw/d.
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In vitro, soluble silicates did not induce gene mutations in bacteria: sodium silicate was negative in
an E. coli reverse mutation assay and sodium metasilicate exerted no mutagenic activity in B.
subtilis and S. typhimurium. In a modern guideline study that was performed in accordance with
OECD TG 473, sodium silicate solution (36 % active ingredient) induced no chromosomal
aberrations in V79 cells, both in the absence and in the presence of metabolic activation. In vivo,
sodium metasilicate did not induce chromosomal aberrations in bone marrow cells of mice in a
study performed similar to OECD TG 475, with the restriction that no information on the use of
positive controls was available for this study. Although the reliability of this study can therefore not
be fully evaluated, the negative result is corroborated by the fact that the chemical structure does
not contain elements that raise concern for a genotoxic activity and by the negative results of
genotoxicity tests with sodium silicate. For the group of soluble silicates under review here, it is
therefore concluded that there is no evidence of a genotoxic potential.
There were no valid carcinogenicity studies available.
The available data on toxicity to reproduction are limited. In a 4-generation study, the total number
of offspring born at 79 mg/kg bw/d was reduced to 67 % and of offspring weaned to 46 % of the
control, respectively. Severe limitations of the study and intercurrent deaths, including controls,
make it however difficult to draw any firm conclusion from this study. In mice, litter size and
fertility index were unaffected at sodium metasilicate concentrations up to and including 200 mg/kg
bw/d. No developmental effects were observed in mice up to and including 200 mg/kg bw/d. In
repeat dose toxicity studies with rats, mice and dogs the macroscopic and microscopic examination
of reproductive organs did not reveal treatment-related effects.
4.1
Aquatic effects
The majority of tests was performed without analytical verification. In these cases, the effect data
refer to the nominal concentrations.
4.1.1
Effects on fish
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Potassium silicates
A 48-hour toxicity test was performed with freshwater golden orfes (Leuciscus idus) according to
DIN 38412/15, a German standard method that corresponds to OECD guideline 203. When exposed
to 500 mg/l of a potassium silicate solution (MR 3.9 4.1, 29.1 wt%) at unknown pH no mortality
or signs of toxicity were observed (Richterich and Mhlberg 2001b). The 48 h LC50 is therefore
> 146 mg active matter/l.
4.1.2
Effects on invertebrates
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matter/l. In two GLP guideline studies complying with German standards corresponding to OECD
209, the toxicity to Pseudomonas putida was tested in oxygen consumption inhibition tests.
Concentrations of a sodium silicate solution (MR 3.0, 34.54 wt%) of up to 3454 mg active matter/l
at pH 8.0 - 11.1 and a sodium metasilicate solution of 1000 mg active matter/l at unknown pH did
not cause toxic effects (Kirch 1993; Richterich and Mhlberg 2001c).
No significant inhibition of respiration was registered at exposure concentrations up to 100 mg/l
sodium metasilicate (MR 1.0, 100 % active matter) for microorganisms from active sludge (Calmels
1994). The 3 h EC50 was > 100 mg active matter/l. The pH of the test media at the start and at the
end of the study was 6.56 - 8.95 and 5.96 - 8.07, respectively. The study was carried out in
compliance with GLP, OECD Guideline 209 and EEC Directive 88/302.
No studies are available for sodium metasilicate, penta- and nonahydrate.
In a simulation test following the OECD confirmatory test procedure, the elimination and influence
of spray-dried sodium silicate (MR 2.1) on the biological activity of a model sewage treatment plant
was determined. At doses of 25 mg/l, sodium silicate had no adverse effect on the biodegradation of
easily degradable nutrients fed simultaneously: DOC (Dissolved Organic Carbon), pH and dry
weight of activated sludge was comparable to the untreated control model plants. Visual inspection
of colour and settling behaviour of activated sludge also did not reveal any differences between
treated and untreated test runs. Elimination of sodium silicate in the model sewage treatment plant
was only marginal; 90 - 100 % was detected in the effluent. The study was carried out in
compliance with GLP and EU guidelines 82/242/EEC and 82/243/EEC (Richterich 1994).
Potassium silicates
No studies are available for potassium silicates.
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Effects [mg/l]
Reference /
Reliability
Danio rerio
semistatic
96 h
1344-09-8 Na
3.46
LC50 = 1108
Adema 1988 * / 1
Danio rerio
semistatic
96 h
6834-92-0 Na
1.0
LC50 = 210
Richterich and
Mhlberg 2001d * / 2
Gambusia
affinis
unknown
96 h
6834-92-0 Na
1.0
LC50 = 2320
Oncorhynch
us mykiss
unknown
96 h
3.1
Maruyama et al.
1989* / 2
Lepomis
unknown
macrochirus
96 h
1344-09-8 Na
unknown
UK Department of the
Environment 1991 / 4
Leuciscus
idus
static
48 h
1312-76-1 K
3.9 - 4.1
Richterich and
Mhlberg 2001b * / 2
Daphnia
magna
static
48 h
1344-09-8 Na 3.2
EC50 = 1700
Kirch 1997 * / 2
Daphnia
magna
unknown
96 h
1344-09-8 Na unknown
Daphnia
magna
unknown
100 h
1344-09-8 Na unknown
EC50 = 247
Daphnia
magna
static
24 h
1312-76-1 K
Richterich and
Mhlberg 2001a * / 2
Amphipoda
(probably
unknown
Hyallela sp.)
96 h
1344-09-8 Na unknown
EC50 = 160
Lymnea sp.
eggs
unknown
96 h
1344-09-8 Na unknown
EC50 = 632
static
72 h
1344-09-8 Na 3.0
Pseudomona
static
s putida
18 h
1344-09-8 Na 3.46
EC0 = 348
EC0 = 3480n
Hanstveit 1989 * / 1
Pseudomona
static
s putida
30 min
1344-09-8 Na 3.0
EC0 = 3454n
Kirch 1993 * / 2
Pseudomona
static
s putida
30 min
6834-92-0 Na 1.0
EC0 = 1000
Richterich and
Mhlberg 2001c * / 2
Activated
sludge
3h
6834-92-0 Na 1.0
EC50 = >100
Calmels 1994 * / 2
Species
Fish
1344-09-8
Na
Invertebrates
3.9 - 4.1
Algae
Scenedesmus
subspicatus
Rieche 1995 * / 2
Microorganisms
static
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PNEC considerations
When assessing the environmental effect of an anthropogenic discharge on aquatic ecosystems, the
predicted no effect concentration (PNEC) is usually put into context with the predicted
environmental concentration (PEC). However, in the case of soluble silicates the calculation of a
PEC and consequently a PEC/PNEC ratio is not feasible. The primary hazard of commercial soluble
silicates is their moderate-to-strong alkalinity, which can be harmful to aquatic life. Thus, the effect
of soluble silicates on aquatic ecosystems depends to a large extent on the local environmental
conditions:
the natural pH of aquatic environments can vary significantly,
the sensitivity of the aquatic ecosystems to a change of the pH can vary significantly
between aquatic ecosystems and
the change in pH due to an anthropogenic discharge is influenced significantly by the
buffer capacity of the receiving water.
To assess the environmental effect of a discharge of soluble silicates, the pH of the receiving water
after the discharge can be calculated based on the pH and buffer capacity of effluent and receiving
water and the dilution factor of the effluent. The pH change can be measured via a laboratory
experiment or by conducting field measurements. The change in pH should be compared with the
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natural variation in pH of the receiving water and based on this comparison it should be assessed if
the pH change is acceptable.
It is not expected that the growth of diatoms and their seasonal fluctuation (blooms) is significantly
influenced by the additional anthropogenic silica input, taking into account that the input of silica
from the use of commercial silicates is negligible as compared to geochemical weathering
processes. The possible effects of anthropogenic silica on diatomaceous growth are discussed in
detail by van Dokkum et al. (2004). They predict i) an extension of the spring (and fall) blooms of
diatoms (which often ends when the dissolved silicate pool is depleted) and (ii) a possible reduction
in summer green or bluegreen algae blooms (because a larger amount of phosphorus is used up in
the spring bloom). This in turn could lead to (iii) a shift in biomass production from summer to
spring and fall, and, possibly, (iv) an overall increase of phytoplankton biomass over the year (when
the increase in summer and fall bloom is larger than the decrease in summer density). However,
these speculations are not corroborated by experimental evidence.
Conclusion
Because the buffer capacity, pH and the fluctuation of the pH are very specific for a certain aquatic
ecosystem and the anthropogenic input is insignificant compared to the natural silica flux it is not
considered useful to derive a PNEC or a PNECadded.
4.2
Terrestrial effects
No data available.
Conclusion
Since silicates are natural components of soil minerals, such tests would be of limited value.
Significant (unintended) exposure of the terrestrial environment as a side effect of applications does
not occur. However, in certain applications soluble silicates are intentionally introduced into the
terrestrial compartment (soil treatment, like sealing around landfill sites, waste fixation, and
coastline stabilisation). Silicates added to or injected into soil react with the acidic constituents and
polyvalent metal ions in the soil to form an impermeable gel structure. Any effects on soil
organisms are confined to the area of soil within which the gel has formed. Due to its impermeable
structure, no leaching into ground water or transport and further spreading of silicate solutions into
soil layers outside the area penetrated by the gel will take place. Terrestrial toxicity tests are
therefore not needed.
4.3
No data available.
4.4
Solid crystalline silicates have discrete melting points which depend on the content of
crystallisation water: anhydrous sodium metasilicate melts at 1089 C while sodium penta- and
nonahydrate melt at 72 C and 48 C, respectively. Due to their glass nature, solid amorphous
silicates do not have discrete melting points but rather flow points. Aqueous silicate solutions have
a melting point only slightly lower than that of water.
The specific gravity or density of silicate solutions depends on the concentration (solids content),
the temperature, and the silica to alkali ratio. Commercial silicate solutions have densities ranging
from ca. 1.2 1.7 g/cm3 at 20 C. Soluble silicates are insoluble in n-octanol.
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The vapour pressures that have been measured for three solid sodium silicates are extremely low:
0.0103 hPa at 1175 C (MR 1.0, metasilicate), 0.0031 hPa at 1165 C (MR 2.0) and 0.0016 hPa at
1172 C (MR 3.0). This indicates that the respective pressures at ambient temperature will be
unmeasurably small.
Crystalline silicates like sodium metasilicate are readily soluble in water. Amorphous silicate
glasses are only slightly attacked by water at ambient temperatures. They can be solubilised only at
elevated temperature and pressure (ca. 150 C and > 5 bar). The solutions are infinitely dilutable
with water. Silicate powders obtained by water evaporation from silicate solutions are readily
soluble in water. The water solubility depends on the pH. Above a pH of 11 - 12 stable solutions of
monomeric and polymeric silicate ions exist. The soluble content rapidly decreases when the pH is
lowered to 9. Below pH 9 only a small proportion is present as soluble monomeric silicate ions, the
majority existing as insoluble amorphous silica gel.
As inorganic substances, soluble silicates are not amenable to photo- or biodegradation. Respiration
of activated sludge is not inhibited at sodium metasilicate concentrations 100 mg/l. Continuous
dosing of 25 mg sodium silicate/l has no adverse effects on the operation of a model sewage
treatment plant simultaneously fed with easily degradable nutrients; no significant elimination
occurred with > 90 % detected in the effluent.
Acute toxicity testing in fish, invertebrates, and algae indicate a low order of toxicity with effect
concentrations between 210 and 1700 mg/l. The following results were obtained in acute tests:
Danio rerio
Danio rerio
Oncorhynchus mykiss
Leuciscus idus
Daphnia magna
Daphnia magna
Scenedesmus subspicatus
RECOMMENDATIONS
The chemicals of the soluble silicates category are currently of low priority for further work.
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Environment: Soluble silicates are currently of low priority for further work because of their low
hazard profile.
Human Health: Soluble silicates possess properties indicating a hazard for human health (irritancy/
corrosivity). In the Sponsor country, adequate risk reduction measures are in place (classification
and labelling). No further work is recommended. In situations where this is not the case, risk
assessment and, if necessary, risk reduction measures are recommended.
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Schleyer WL and Blumberg JG (1982). Health, safety, and environmental aspects of soluble
silicates. In: Soluble Silicates, ACS Symposium Series 194. American Chemical Society,
Washington. Chapter 4, 49-69.
Schulz M (2006). In vitro Chromosome Aberration Test in Chinese Hamster V79 Cells with C-SAT
050049. RCC-CCR Study Number 901400. RCC-Cytotest Cell Research GmbH. Study Sponsor:
CEES Soluble Silicates Consortium.
47
UNEP PUBLICATIONS
OECD SIDS
SOLUBLE SILICATES
Sigrist T, Flury K (1985). Tod durch perorale Aufnahme von Wasserglas (Natriumsilikat). Z.
Rechtsmed. 94, 245-250.
Smith GS, Neumann AL, Gledhill VH and Arzola CA (1973). Effects of soluble silica on growth,
nutrient balance and reproductive performance of albino rats. J. Animal Sc. 36 (2): 271-278.
Spanjers MTh and Til HP (1981a). Determination of the acute oral toxicity of natron waterglas
38/40 (3.27) in rats. TNO CIVO. Report no. R0100872.
Spanjers MTh and Til HP (1981b). Determination of the acute oral toxicity of natron waterglas
40/42 (2.0) in rats. TNO CIVO. Report no. R0100874.
Spanjers MTh and Til HP (1981c). Determination of the acute oral toxicity of kali waterglas
35.5/36.5 (2.25) in rats. TNO CIVO. Report no. R0100873.
Tanaka T, Miyachi Y and Horio T (1982). Ulcerative contact dermatitis caused by sodium silicate.
Coexistence of primary irritant contact dermatitis and contact urticaria. Arch. Dermatol. 118(7),
518-20.
UK Department of the Environment (1991). Pollutants in Cleaning Agents, Final Report,
Consultants in Environmental Sciences Ltd.
Van Dokkum HP, Hulskotte JHJ, Kramer KJM and Wilmot J (2004). Emission, Fate and Effects of
Soluble Silicates (Waterglass) in the Aquatic Environment. Environ. Sci. Technol. 38, 515-521.
Vymazal J (1995). Algae and element cycling in wetlands. Lewis Publishers, Boca Raton, USA,
347-350.
Wallen IE, Greer WC and Lasater R (1957). Toxicity to Gambusia affinis of certain pure chemicals
in turbid waters. Sew. Industr. Wastes 29(6), 695-711.
Wilson A and Hartop P (1993). Sodium silicate 2.0 ratio, sodium silicate 2.4 ratio, sodium
silicate 2.6 ratio, sodium silicate 2.8 ratio, sodium silicate 3.0 ratio, sodium silicate 3.3 ratio:
the in vitro rabbit eye irritation test. Environmental safety laboratory, Unilever research. Report no.
R1930174.
Wilson A and Lea L (1994). Sodium silicate 1.5 ratio, sodium silicate 1.6 ratio and sodium silicate
1.8 ratio: the in vitro rabbit eye test. Environmental safety laboratory, Unilever research, Report no.
RI930472.
York M, Wilson AP and Newsome CS (1994). The classification of soluble silicates for eye hazard
using the enucleated rabbit eye test. Toxic. in vitro 8, 1265-1268.
UNEP PUBLICATIONS
48
OECD SIDS
SOLUBLE SILICATES
APPENDIX 1: USES OF SOLUBLE SILICATES RECORDED BY 4 EUROPEAN PRODUCT REGISTERS (SWEDEN, FINLAND,
DENMARK AND SWITZERLAND)
Sweden
Substance
Sodium metasilicate,
anhydrous
Sodium metasilicate,
pentahydrate
Sodium metasilicate,
nonahydrate
CAS no.
1312-76-1
1344-09-8
6834-92-0
10213-79-3
13517-24-3
Total amount of
substance in
product
Quantity in
tons / year
0-2%
29 / 10
14
2-20%
97 / 25
287
20-80%
22 / 3
449
80-100%
4/0
425
total
152 / 38
1,176
0-2%
52 / 23
27
2-20%
260 / 120
1,884
20-80%
91 / 30
8,956
80-100%
17 / 2
17,016
total
420 / 175
27,883
0-2%
199 / 56
87
2-20%
295 / 38
549
20-80%
133 / 22
853
80-100%
8/0
20,194
total
635 / 116
21,683
0-2%
85 / 13
23
2-20%
178 / 17
204
20-80%
54 / 8
374
80-100%
3/0
410
total
320 / 38
1,010
0-80%
4/1
UNEP PUBLICATIONS
Information on
Product Register
National Chemicals
Inspectorate, Sweden
Year of data
collection: 2001
Updated yearly
Various
49
OECD SIDS
SOLUBLE SILICATES
Finland
Substance
Sodiummetasilicate,
anhydrous
Sodiummetasilicate,
pentahydrate
50
CAS no.
Total amount of
substance in
product
No. of products 1
1-10%
16
10-30%
17
total
33
Quantity
in tons /
year
1312-76-1
1344-09-8
6834-92-0
10213-79-3
0-5%
16
5-10%
15
10-30%
31
30-60%
16
60-100%
total
85
0-1%
1-5%
125
5-10%
54
10-30%
127
30-60%
21
60-100%
total
339
0-5%
80
5-10%
10
10-30%
16
30-60%
277
4,971
2,550
Cleaning/washing agents
in:
Industrial cleaning
UNEP PUBLICATIONS
Information on
Product Register
Product Control
Agency for Welfare
and Health in
Finland, Product
Register Unit
Year of data
collection: 2001
Updated yearly
OECD SIDS
Sodiummetasilicate,
nonahydrate
SOLUBLE SILICATES
13517-24-3
60-100%
total
117
1-5%
5-10%
10-100%
total
10
765
17
Cleaning/washing agents
in:
Manufacture of soap and detergents,
cleaning and polishing preparations,
perfumes and toilet preparations,
Manufacture of other fabricated metal
products, Industrial cleaning
The number of consumer products is not reported, only the total number of products is given.
UNEP PUBLICATIONS
51
OECD SIDS
SOLUBLE SILICATES
Denmark
Substance
Potassium silicate
total number
Potassium silicate
by product group
Sodium silicates
total number
CAS no.
1312-76-1
1312-76-1
1344-09-8
Total amount of
substance in
product
Quantity
in tons /
year
0-2%
16 / NR1
2-20%
65 / NR
75
20-50%
10 / NR
11
50-100%
4 / NR
2,010
total
3 / NR
2,000
Impregnation materials
2-20%
3 / NR
Photochemicals
total
3 / NR
2-20%
3 / NR
<1
total
3 / NR
<1
0-2%
13 / NR
2-20%
46 / NR
70
total
61 / NR
76
2-20%
3 / NR
total
4 / NR
2-20%
8 / NR
20-50%
5 / NR
total
13 / NR
10
total
3 / NR
<1
Surface treatment
0-2%
58 / NR
36
2-20%
161 / NR
1,844
Information on Product
Register
The Danish Product
Register, Denmark
Year of data collection: ?
Information received:
26.02.2002
Frequency of update: ?
Reprographic agents
Cleaning / washing agents
NR = not reported
2 Manufacture of food, beverages and tobacco / Dairies and manufacture of condensed milk / Manufacture of beer / Painting and glazing / Hotels / Restaurants / cafeterias
and community centres / Industrial cleaning / Hospital activities / Social work activities including residential institutions / Laundries and dry cleaners
52
UNEP PUBLICATIONS
OECD SIDS
SOLUBLE SILICATES
Denmark
Substance
Sodium silicates
by product group
CAS no.
1344-09-8
Total amount of
substance in
product
Quantity
in tons /
year
20-50%
37 / NR
661
50-100%
14 / NR
2,378
2-20%
3 / NR
50-100%
6 / NR
2,144
total
12 / NR
2,217
20-50%
3 / NR
total
4 / NR
0-2%
6 / NR
total
6 / NR
0-2%
3 / NR
<1
total
5 / NR
total
3 / NR
2,005
Cosmetics
0-2%
3 / NR
<1
Fillers
2-20%
3 / NR
20-50%
7 / NR
42
50-100%
4 / NR
total
17 / NR
53
total
3 / NR
<1
Insulating materials
2-20%
5 / NR
Reprographic agents
total
6 / NR
Information on Product
Register
Process regulators
Anti-freezing agents
Corrosion inhibitors
Manufacture of food, beverages and tobacco / Manufacture of fabricated metal products, except machinery and equipment / Maintenance and repair of motor vehicles /
Hotels and restaurants / Restaurants, cafeterias and community centres / Industrial cleaning / Hospital activities / Laundries and dry cleaners / Private households with
employed persons / Other activities.
UNEP PUBLICATIONS
53
OECD SIDS
SOLUBLE SILICATES
Denmark
Substance
Disodium metasilicate
total number
Disodium metasilicate
by product group
CAS no.
6834-92-0
6834-92-0
Total amount of
substance in
product
Quantity
in tons /
year
0-2%
37 / NR
29
2-20%
132 / NR
1,797
20-50%
15 / NR
413
total
185 / NR
2,247
0-2%
4 / NR
<1
total
8 / NR
2-20%
6 / NR
total
8 / NR
total
3 / NR
Surface treatment
2-20%
4 / NR
Others
20-50%
3 / NR
162
total
7 / NR
166
0-2%
156 / NR
30
2-20%
319 / NR
303
20-50%
72 / NR
345
50-100%
44 / NR
417
0-2%
3 / NR
<1
total
3 / NR
<1
total
3 / NR
Process regulators
0-2%
31 / NR
18
Anti-freezing agents
Information on Product
Register
Construction materials
Non-agricultural pesticides and
preservatives
Pesticides, agricultural
Manufacture of food, beverages and tobacco / Manufacture of iron and metal products / Manufacture of fabricated metal products, except machinery and equipment /
Manufacture of machinery and equipment / Maintenance and repair of motor vehicles / Restaurants, cafeterias and community centres / Industrial cleaning / Hospital
activities / Laundries and dry cleaners / Private households with employed persons
54
UNEP PUBLICATIONS
OECD SIDS
SOLUBLE SILICATES
Denmark
Substance
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
total
31 / NR
18
2-20%
3 / NR
total
4 / NR
0-2%
4 / NR
<1
2-20%
5 / NR
total
10 / NR
181
total
5 / NR
Fillers
2-20%
6 / NR
Photochemicals
total
7 / NR
2-20%
12 / NR
14
total
15 / NR
15
2-20%
3 / NR
total
6 / NR
0-2%
99 / NR
12
2-20%
271 / NR
302
20-50%
64 / NR
336
50-100%
37 / NR
416
total
471 / NR
1,066
0-2%
8 / NR
2-20%
8 / NR
total
20 / NR
22
0-2%
3 / NR
<1
total
3 / NR
<1
UNEP PUBLICATIONS
Information on Product
Register
Bleaching agents
Corrosion inhibitors
Reprographic agents
Surface-active agents
Cutting fluids
55
OECD SIDS
SOLUBLE SILICATES
Denmark
Substance
56
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
total
3 / NR
<1
0-2%
3 / NR
<1
Surface treatment
2-20%
4 / NR
total
7 / NR
2-20%
3 / NR
<1
total
3 / NR
<1
UNEP PUBLICATIONS
Others
Information on Product
Register
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
CAS no.
Total amount of
substance in
product
Sodium silicates
(3:2)
1344-09-8
0.1-1%
1/0
0.1-1%
1/0
Auxiliary agents
10-50%
2/2
1-10%
1/0
Metal-care products
1-10%
2/2
Cleaning agents
10-50%
1/0
1-10%
1/1
0.1-1%
1/0
Antirust agents
1-10%
2/1
Dishwashing agents
1-10%
7/7
Photochemicals
10-50%
2/2
0-0.1%
1/0
0-1%
7/7
0.1-1%
11 / 0
0-1%
1/0
0.1-1%
1/0
0-0.1%
3/0
0.1-1%
4/0
1-10%
2/1
10-50%
3/0
Sodium silicates
(1:2 to 1:4)
1344-09-8
Quantity
in tons /
year
Information on
Product Register
Swiss Federal Office of
Public Health,
Chemical Products
Division
Year of data collection:
2001
Frequency of update: ?
Anti-freezing agents
UNEP PUBLICATIONS
57
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
58
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
0.1-1%
3/0
1-10%
1/0
10-50%
1/0
0-0.1%
3/0
0.1-1%
6/0
1-10%
17 / 0
10-50%
23 / 3
50-100%
8/1
0-0.1%
2/1
0.1-1%
2/1
1-10%
5/0
10-50%
42 / 14
50-100%
18 / 8
50-100%
1/1
0-0.1%
1/1
Metal-care products
0.1-1%
2/0
1-10%
1/0
10-50%
5/4
50-100%
1/0
0-0.1%
1/0
1-10%
2/0
10-50%
1/1
50-100%
1/0
Auxiliary agents
UNEP PUBLICATIONS
Information on
Product Register
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
0-0.1%
4/1
0.1-1%
23 / 5
1-10%
76 / 13
10-50%
24 / 3
50-100%
3/1
0-0.1%
5/2
0.1-1%
7/4
1-10%
76 / 46
10-50%
8/3
50-100%
1/0
1-10%
8/0
10-50%
1/0
1-10%
1/0
50-100%
1/0
0.1-1%
4/0
1-10%
3/0
10-50%
6/1
50-100%
1/0
10-50%
1/0
1-10%
7/6
10-50%
43 / 16
50-100%
7/4
10-50%
2/0
Antirust agents
10-50%
2/0
Various
Information on
Product Register
Cleaning agents
UNEP PUBLICATIONS
59
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
CAS no.
1312-76-1
Total amount of
substance in
product
Quantity
in tons /
year
50-100%
1/1
0.1-1%
7/1
1-10%
24 / 5
10-50%
6/1
1-10%
6/0
10-50%
6/0
50-100%
1/0
0-0.1%
1/0
1-10%
1/0
10-50%
2/2
0.1-1%
3/3
1-10%
2/2
0.1-1%
1/0
1-10%
2/0
10-50%
4/0
0.1-1%
1/0
Anti-freezing agents
0.1-1%
1/0
Laboratory chemicals
1-10%
1/1
0-0.1%
1/1
Stain remover
0.1-1%
1/1
10-50%
1/1
50-100%
3/0
Fire-extinguishing agents
0-0.1%
9/5
0.1-1%
3/1
Dishwashing agents
Photochemicals
Disinfectants, biostatics
UNEP PUBLICATIONS
Information on
Product Register
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
1-10%
100 / 11
10-50%
70 / 11
50-100%
8/1
0.1-1%
2/0
1-10%
15 / 1
10-50%
32 / 1
50-100%
5/0
0.1-1%
1/1
1-10%
23 / 2
10-50%
12 / 0
50-100%
5/2
0.1-1%
2/1
Metal-care products
0.1-1%
1/1
1-10%
2/0
0-0.1%
1/0
0.1-1%
8/1
1-10%
34 / 7
10-50%
27 / 4
50-100%
1/0
0.1-1%
1/0
1-10%
4/2
10-50%
10 / 2
50-100%
1/0
1-10%
1/1
Information on
Product Register
Auxiliary agents
Cleaning agents
Herbicides
UNEP PUBLICATIONS
61
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
62
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
1-10%
3/1
10-50%
3/0
1-10%
1/0
10-50%
1/0
50-100%
1/0
10-50%
1/0
10-50%
1/0
50-100%
2/0
1-10%
2/0
10-50%
1/0
0.1-1%
1/1
50-100%
2/0
10-50%
1/1
Fungicides
0-0.1%
1/0
Various
10-50%
2/1
1-10%
10 / 0
10-50%
11 / 4
10-50%
1/1
Antistatic agent
0.1-1%
1/0
Photochemicals
1-10%
18 / 0
10-50%
6/0
1-10%
1/1
10-50%
1/0
1-10%
2/2
Impregnation agents
Antirust agents
Dishwashing agents
Disinfectants, biostatics
Swimming pool chemicals
UNEP PUBLICATIONS
Information on
Product Register
OECD SIDS
SOLUBLE SILICATES
Switzerland
Substance
CAS no.
Total amount of
substance in
product
Quantity
in tons /
year
1-10%
1/0
10-50%
1/0
0-0.1%
1/1
Agricultural fertilizers
0-0.1%
1/1
Information on
Product Register
Electroplating auxiliary
UNEP PUBLICATIONS
63
OECD SIDS
SOLUBLE SILICATES
Existing Chemical
CAS No.
EINECS Name
EC No.
TSCA Name
ID: 1344-09-8
1344-09-8
Silicic acid, sodium salt
215-687-4
Silicic acid, sodium salt
Printing date:
Revision date:
Date of last Update:
05-APR-2006
Number of Pages:
138
05-APR-2006
Chapter (profile):
Chapter: 1, 2, 3, 4, 5
Reliability (profile): Reliability: without reliability, 1, 2, 3, 4
Flags (profile):
Flags: without flag, confidential, non confidential, WGK
(DE), TA-Luft (DE), Material Safety Dataset, Risk
Assessment, Directive 67/548/EEC, SIDS
64
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
lead organisation
Centre Europeen d'Etude des Silicates (CEES)
Jol Wilmot
Date: 28-FEB-2003
Av. E van Nieuwenhuyse, 4
B-1160 Bruxelles
Belgium
+32 26767288
+32 26767347
Remark:
http://www.cees-silicates.org
Remark:
65
OECD SIDS
1. GENERAL INFORMATION
Remark:
12-DEC-2003
1.1.2 Spectra
1.2 Synonyms and Tradenames
Silicic acid, sodium salt
09-JAN-2002
Silicon sodium oxide
13-NOV-1995
66
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
Sodium .beta.-silicate
13-NOV-1995
Sodium sesquisilicate
13-NOV-1995
Sodium silicate
21-MAR-1994
Sodium silicate glass
24-MAR-1994
Sodium water glass
24-MAR-1994
Soluble glass
24-MAR-1994
Waterglass
11-NOV-2002
1.3 Impurities
Purity type:
Remark:
Impurities stem from the quartz sand used rather than from
soda. Therefore, impurities of potassium silicates are
similar to sodium silicates of comparable molar ratios. The
following impurities were reported for sodium silicate lumps
of weight ratio 3.35 (molar ratio 3.46):
Reliability:
Flag:
03-DEC-2003
Na2SO4: 0.06%
NaCl: 0.06%
Fe2O3: 0.033%
Al2O3: 0.097%
CaO: 0.03%
MgO: 0.02%
TiO2: 0.019%
(4) not assignable
Review article only
Critical study for SIDS endpoint
(14)
Purity type:
Remark:
Result:
Li
0.2-0.5
UNEP PUBLICATIONS
67
OECD SIDS
1. GENERAL INFORMATION
K
Mg
Ca
Sr
Ba
Al
P
S
Ti
V
Cr
Mn
Fe
Co
Ni
Cu
Zn
La
Ce
Zr
W
Reliability:
Flag:
29-MAR-2005
20-50
5-20
1-80
1-5
<1-5
50-200
<1-10
10-30
30-80
0.1-0.8
<1
<0.5-1
25-100
<1
<0.5
<0.1-0.2
<0.2-1
0.2-1
<0.3-2
5-20
<1-25
1.4 Additives
1.5 Total Quantity
Quantity:
Remark:
Reliability:
Quantity
(4) not
Handbook
Critical
Flag:
29-MAR-2005
(35)
1.6.1 Labelling
Labelling:
provisionally by manufacturer/importer
Remark:
68
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
MR
Mean total solids [%]
-------------------------------1.65
47-53
2.1
42-54
2.6
44
2.8
46
3.3
36-40
3.5
36
4
28
23-JAN-2004
1.6.2 Classification
1.6.3 Packaging
1.7 Use Pattern
Type:
Category:
type
Non dispersive use
06-FEB-2003
Type:
Category:
type
Use resulting in inclusion into or onto matrix
06-FEB-2003
Type:
Category:
type
Wide dispersive use
06-FEB-2003
Type:
Category:
industrial
Chemical industry: used in synthesis
06-FEB-2003
Type:
Category:
industrial
Paints, lacquers and varnishes industry
06-FEB-2003
Type:
industrial
UNEP PUBLICATIONS
69
OECD SIDS
1. GENERAL INFORMATION
Category:
06-FEB-2003
Type:
Category:
industrial
Personal and domestic use
06-FEB-2003
Type:
Category:
industrial
Textile processing industry
06-FEB-2003
Type:
Category:
industrial
other: civil engineering
06-FEB-2003
Type:
Category:
industrial
other: foundry industry
06-FEB-2003
Type:
Category:
industrial
other: tertiary oil recovery
15-DEC-2003
Type:
Category:
use
Adhesive, binding agents
Remark:
15-DEC-2003
Type:
Category:
use
Cleaning/washing agents and disinfectants
Remark:
15-DEC-2003
Type:
Category:
use
Construction materials additives
Remark:
15-DEC-2003
Type:
Category:
use
Corrosive inhibitors
Remark:
15-DEC-2003
Type:
Category:
use
Cosmetics
(5) (58)
15-DEC-2003
70
(9)
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
Type:
Category:
use
Fillers
Remark:
15-DEC-2003
Type:
Category:
use
Flame retardants and fire preventing agents
Remark:
15-DEC-2003
Type:
Category:
use
Flotation agents
15-DEC-2003
(9) (34)
(5)
Type:
Category:
use
Intermediates
Remark:
15-DEC-2003
Type:
Category:
use
Non agricultural pesticides
15-DEC-2003
Type:
Category:
(9)
use
Photochemicals
15-DEC-2003
(58)
Type:
Category:
use
Welding and soldering agents
Remark:
15-DEC-2003
Type:
Category:
use
other: Anti-freezing agents
15-DEC-2003
(58)
Type:
Category:
use
other: Titanium dioxide production
Remark:
15-DEC-2003
Type:
Category:
use
other: additive in paper production
Remark:
15-DEC-2003
Type:
Category:
use
other: binder in foundry sand
(38)
UNEP PUBLICATIONS
71
OECD SIDS
1. GENERAL INFORMATION
Remark:
15-DEC-2003
Type:
Category:
use
other: car-care product
15-DEC-2003
Type:
Category:
(58)
use
other: cleaning agent in food and beverage industry
15-DEC-2003
(9)
Type:
Category:
use
other: oil flow improver
Remark:
15-DEC-2003
Type:
Category:
use
other: paint additive
Remark:
15-DEC-2003
Type:
Category:
use
other: sealing agent in soil
Remark:
08-JAN-2004
Type:
Category:
use
other: textile treatment additive
Remark:
15-DEC-2003
(38) (58)
(5) (34)
72
OECD SIDS
1. GENERAL INFORMATION
16-DEC-2003
KBwS (DE)
1 (weakly water polluting)
Remark:
Reliability:
08-JAN-2004
21-OCT-2004
Source of exposure: Human: exposure through intended use
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Human: exposure of the consumer/bystander
Exposure to the:
Substance
UNEP PUBLICATIONS
73
OECD SIDS
1. GENERAL INFORMATION
Remark:
21-OCT-2004
Source of exposure: Environment: exposure from production
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Environment: exposure from formulation
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Environment: exposure from processing
Exposure to the:
Substance
Remark:
21-OCT-2004
21-OCT-2004
Source of exposure: Environment: exposure through private use
Exposure to the:
Substance
Remark:
21-OCT-2004
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Remark:
Flag:
16-DEC-2003
Value:
Decomposition:
760 degree C
no at degree C
Remark:
20-OCT-2004
Value:
Decomposition:
840 degree C
no at degree C
Remark:
Reliability:
Test substance:
Reliability:
Test substance:
Reliability:
20-OCT-2004
2.2 Boiling Point
Value:
Remark:
30-SEP-2004
2.3 Density
UNEP PUBLICATIONS
75
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Type:
Value:
density
1.26 - 1.5 g/cm at 20 degree C
Test substance:
Reliability:
Flag:
20-OCT-2004
Type:
Value:
density
ca. 1.26 - 1.71 g/cm at 20 degree C
Remark:
Flag:
20-OCT-2004
Type:
Value:
density
1.32 - 1.68 g/cm at 20 degree C
Test substance:
Reliability:
Flag:
20-OCT-2004
Type:
Value:
bulk density
ca. 700 kg/m3 at 20 degree C
Test substance:
Reliability:
Test substance:
Reliability:
Flag:
20-OCT-2004
Type:
Value:
bulk density
ca. 800 kg/m3 at 20 degree C
Test substance:
Reliability:
Flag:
20-OCT-2004
(48)
2.3.1 Granulometry
2.4 Vapour Pressure
Value:
Method:
76
(47)
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
GLP:
no data
Remark:
Test substance:
Reliability:
Flag:
08-JAN-2004
Value:
Method:
GLP:
Remark:
Test substance:
Reliability:
Flag:
08-JAN-2004
(33)
Reliability:
Flag:
20-OCT-2004
value:
Remark:
Reliability:
Flag:
19-OCT-2004
Remark:
Reliability:
11 - 13
Alkaline silicates are completely insoluble in n-octanol.
The pH in alkaline silicates is dependant on the silica to
alkali ratio and the concentrations of the individual
solutions. Concentrated solutions usually have a pH between
10 and 13.
(4) not assignable
Product brochure of producers association; data without proof.
Critical study for SIDS endpoint
(5)
77
OECD SIDS
2. PHYSICO-CHEMICAL DATA
19-OCT-2004
(22)
Solubility in:
Value:
Water
115 mg/l at 25 degree C
Remark:
Reliability:
Flag:
03-DEC-2003
Remark:
Reliability:
Flag:
21-OCT-2004
Remark:
Reliability:
21-OCT-2004
(38)
Solubility in:
Water
Remark:
Reliability:
Flag:
19-OCT-2004
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Remark:
Reliability:
21-OCT-2004
2.9 Flammability
Result:
non flammable
Remark:
Reliability:
21-OCT-2004
not explosive
Remark:
Reliability:
21-OCT-2004
no oxidizing properties
Remark:
Reliability:
21-OCT-2004
Remark:
79
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Reliability:
28.1
34.4
34.9
36.4
38.0
41.4
43.3
45.0
47.0
54.5
(4) not assignable
Collection of data
3.97
3.40
3.46
3.44
3.42
3.17
2.69
2.84
2.48
2.09
25
45
80
180
550
1100
400
2000
1750
ca. 100 000
17-DEC-2003
(18)
Value:
Remark:
Reliability:
Total solids
Molar ratio
Viscosity
wt %
SiO2/Na2O
mPa.s at 20C
------------------------------------------------28.0
3.97
20
38.1
3.41
250-500
42.1
2.06
200
43.6
2.58
400
(4) not assignable
Handbook data
21-OCT-2004
(38)
80
UNEP PUBLICATIONS
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
3.1.1 Photodegradation
Remark:
Reliability:
26-JAN-2004
abiotic
Remark:
Reliability:
29-MAR-2005
Remark:
Reliability:
18-DEC-2003
Polymerisation-Depolymerisation:
Upon dilution of concentrated commercial silicate solutions
with water, the highly cross-linked polysilicate ions
depolymerize rapidly to monosilicate ions, the extent of
depolymerisation depending on the dilution factor.
(2) valid with restrictions
Acceptable procedure and publication
(41)
81
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Medium:
Remark:
Reliability:
Flag:
18-DEC-2003
Reliability:
82
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Flag:
29-MAR-2005
Remark:
SiO2 enters surface waters via the four main application areas
where emissions to water systems might occur (household
detergents, pulp-and paper production, water treatment, and
soil stabilisation).
Seen in the context of the natural silica cycle, and natural
loading of water systems with silicates due to weathering of
soil and rocks, weathering of sediments and atmospheric
deposition, this amount is small.
(2) valid with restrictions
Well-documented scientific publication.
Critical study for SIDS endpoint
(50) (61)
Reliability:
Flag:
18-DEC-2003
(15) (24)
Reliability:
29-MAR-2005
3.3.2 Distribution
Remark:
18-DEC-2003
aerobic
other: activated sludge of a predominantly domestic sewage
25 mg/l related to Test substance
Method:
Year:
GLP:
Method:
83
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Result:
Test condition:
Test substance:
Reliability:
Flag:
18-DEC-2003
Remark:
Reliability:
29-MAR-2005
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
29-MAR-2005
3.7 Bioaccumulation
Remark:
Reliability:
19-DEC-2003
Remark:
Reliability:
29-MAR-2005
UNEP PUBLICATIONS
85
OECD SIDS
4. ECOTOXICITY
AQUATIC ORGANISMS
4.1 Acute/Prolonged Toxicity to Fish
Type:
Species:
Exposure period:
Unit:
NOEC:
LC50:
LC100:
semistatic
other: Brachydanio rerio (now Danio rerio)
96 hour(s)
mg/l
Analytical monitoring: no
= 348
= 1108
= 1949
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
86
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
Flag:
30-SEP-2004
Species:
Exposure period:
Unit:
LC50:
Lepomis macrochirus
96 hour(s)
mg/l
= 301 - 478
Method:
GLP:
other
no data
(1)
UNEP PUBLICATIONS
87
OECD SIDS
4. ECOTOXICITY
Test substance:
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
(60)
Species:
Exposure period:
Unit:
LC50:
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
88
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
Test substance:
Conclusion:
Reliability:
Flag:
30-SEP-2004
Daphnia magna
100 hour(s)
mg/l
247
Method:
Year:
GLP:
Test substance:
other
1953
no
other TS
Method:
Result:
(Crustacea)
Analytical monitoring: no data
UNEP PUBLICATIONS
89
OECD SIDS
4. ECOTOXICITY
Test condition:
90
OECD SIDS
4. ECOTOXICITY
30-SEP-2004
Species:
Exposure period:
Unit:
EC50:
Daphnia magna
96 hour(s)
mg/l
216 - 247
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
Test substance:
(Crustacea)
Analytical monitoring: no data
UNEP PUBLICATIONS
91
OECD SIDS
4. ECOTOXICITY
Reliability:
06-FEB-2003
(12) (60)
Type:
Species:
Exposure period:
Unit:
EC0:
EC50:
EC100:
static
Daphnia magna
48 hour(s)
mg/l
100
1700
10000
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
92
(Crustacea)
Analytical monitoring: yes
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
Flag:
30-SEP-2004
Species:
Exposure period:
Unit:
EC50:
(30)
93
OECD SIDS
4. ECOTOXICITY
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
Species:
Exposure period:
Unit:
EC50:
Method:
Year:
GLP:
Test substance:
Method:
94
UNEP PUBLICATIONS
(12)
OECD SIDS
4. ECOTOXICITY
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
(12)
Method:
Year:
GLP:
Test substance:
Method:
Result:
UNEP PUBLICATIONS
95
OECD SIDS
4. ECOTOXICITY
Test condition:
96
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
Flag:
25-NOV-2003
aquatic
Pseudomonas putida
18 hour(s)
mg/l
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
(Bacteria)
Analytical monitoring: no
97
OECD SIDS
4. ECOTOXICITY
Flag:
06-FEB-2003
Species:
Exposure period:
Unit:
NOEC:
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
98
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
Test condition:
Test substance:
Reliability:
18-DEC-2003
Species:
Exposure period:
Unit:
EC0:
EC10 :
Pseudomonas putida
30 minute(s)
mg/l
3454
Method:
Year:
GLP:
Test substance:
Method:
Result:
(Bacteria)
Analytical monitoring:
UNEP PUBLICATIONS
99
OECD SIDS
4. ECOTOXICITY
Test condition:
Test substance:
Reliability:
Flag:
25-NOV-2003
100
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
TERRESTRIAL ORGANISMS
4.6.1 Toxicity to Sediment Dwelling Organisms
4.6.2 Toxicity to Terrestrial Plants
4.6.3 Toxicity to Soil Dwelling Organisms
4.6.4 Toxicity to other Non-Mamm. Terrestrial Species
4.7 Biological Effects Monitoring
4.8 Biotransformation and Kinetics
4.9 Additional Remarks
UNEP PUBLICATIONS
101
OECD SIDS
5. TOXICITY
Result:
Reliability:
16-JUL-2003
Result:
Reliability:
21-NOV-2003
Result:
Reliability:
21-NOV-2003
102
OECD SIDS
5. TOXICITY
LD50
rat
3200 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
06-FEB-2003
Type:
Species:
Value:
LD50
rat
1600 - 8600 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
103
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
06-FEB-2003
(50)
Type:
Species:
Value:
LD50
rat
1500 - 2200 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
06-FEB-2003
Type:
Species:
Value:
LD50
rat
1300 - 2100 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
104
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
06-FEB-2003
(50)
Type:
Species:
Value:
LD50
rat
1600 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
06-FEB-2003
Type:
Species:
Strain:
Sex:
No. of Animals:
Vehicle:
Doses:
Value:
LD50
rat
other: Cpb:Wu; Wistar random
male/female
50
no data
3.30, 3.96, 4.75, 5.70, 6.86 g/kg bw
= 3400 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1981
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
105
OECD SIDS
5. TOXICITY
Flag:
06-FEB-2003
Type:
Species:
Strain:
Sex:
No. of Animals:
Vehicle:
Doses:
Value:
LD50
rat
other: Cpb:Wu; Wistar Random
male/female
60
no data
3.43, 4.11, 4.93, 5.89, 7.12, 8.49 g/kg bw
= 5150 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Test condition:
Test substance:
Reliability:
106
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
Flag:
06-FEB-2003
MORTALITY:
- Time of death: Between 3 hours and 3 days after dosing
- Number of deaths at each dose:
Dose
male
female
3.43
0/5
0/5
4.11
1/5
1/5
4.93
4/5
5/5
5.89
4/5
5/5
7.12
4/5
5/5
8.49
5/5
5/5
CLINICAL SIGNS: Sedation, abdominal discomfort, sluggishness
and unconsciousness. Survivors recovered at the end of the
14-day observation period.
NECROPSY FINDINGS: No treatment related gross alterations
POTENTIAL TARGET ORGANS: Not reported
SEX-SPECIFIC DIFFERENCES: Not reported
TNO Voeding AJ Zeist
TEST ORGANISMS:
- Strain: Not reported
- Source: The Central Institute for Breeding of Laboratory
Animals TNO, Zeist, The Netherlands.
- Age: Young adult
- Weight at study initiation: 225-300 g (males), 143-214 g
(females)
- Number of animals: 60, 5/sex/dose
- Controls: Not reported
ADMINISTRATION:
- Doses: 3.43, 4.11, 4.93, 5.89, 7.12, 8.49 g/kg bw
- Doses per time period: single doses administered
- Volume administered: 2.5, 3.0, 3.6, 4.3, 5.2, 6.2 ml/kg
- Post dose observation: 14 days after treatment
EXAMINATIONS: Mortality, clinical signs and autopsy
(microscopic and macroscopic).
SOURCE: AKZO N.V.
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: The test substance Natron waterglass
38/40 (ratio 3.27) is a clear colourless liquid. The density
was 1.37. Concentration not indicated.
(2) valid with restrictions
Test procedure according to national standards; report with
limited detail.
Critical study for SIDS endpoint
(55)
Type:
Species:
Value:
LD50
rat
1000 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
Source:
Test condition:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
107
OECD SIDS
5. TOXICITY
06-FEB-2003
Type:
Species:
Value:
LD50
rat
1500 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
06-FEB-2003
Type:
Species:
Value:
LD50
rat
500 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
Test substance:
Reliability:
Result:
108
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
Type:
Species:
Strain:
Sex:
Vehicle:
Value:
LD50
rat
Wistar
male
water
8650 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1971
no
other TS
Method:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
UNEP PUBLICATIONS
109
OECD SIDS
5. TOXICITY
Type:
Species:
Value:
LD50
rat
2000 - 2500 mg/kg bw
Method:
GLP:
Test substance:
other
no
other TS
Method:
06-FEB-2003
Type:
Species:
Vehicle:
Doses:
Value:
LD50
rat
no data
no data
> 2000 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1982
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
Test substance:
Reliability:
110
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
(44)
Type:
Species:
Sex:
Vehicle:
Doses:
Value:
LD50
mouse
male
no data
no data
= 6600 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1973
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
UNEP PUBLICATIONS
111
OECD SIDS
5. TOXICITY
rabbit
38.3 other: wt%
Semiocclusive
4 hour(s)
1
.33
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Flag:
22-JAN-2004
Species:
Concentration:
rabbit
39 other: wt%
Result:
Test condition:
Test substance:
Reliability:
112
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
Semiocclusive
4 hour(s)
1
0
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Flag:
04-AUG-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
rabbit
39.9 other: wt%
Semiocclusive
4 hour(s)
1
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
113
OECD SIDS
5. TOXICITY
PDII:
Result:
3
irritating
Method:
Year:
GLP:
Test substance:
Method:
Flag:
04-AUG-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
40.9 other: wt%
Semiocclusive
4 hour(s)
1
3
irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
114
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Year:
GLP:
Test substance:
1985
yes
other TS
Method:
Flag:
04-AUG-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
53.5 other: wt%
Semiocclusive
4 hour(s)
3
8
corrosive
Method:
Year:
GLP:
Test substance:
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
115
OECD SIDS
5. TOXICITY
Method:
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
34.5 other: wt%
Semiocclusive
4 hour(s)
3
.4
not irritating
Method:
Year:
Result:
Test condition:
Test substance:
Reliability:
116
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
GLP:
Test substance:
yes
other TS
Method:
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
99 other: wt%
Occlusive
24 hour(s)
4
irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
117
OECD SIDS
5. TOXICITY
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
80 other: wt%
Occlusive
24 hour(s)
0
not irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
118
OECD SIDS
5. TOXICITY
06-FEB-2003
ADMINISTRATION/EXPOSURE
- Preparation of test substance: Not reported
- Area of exposure: intact and abraded skin
- Occlusion: yes
- Vehicle: Not reported
- Concentration in vehicle: not reported
- Total volume applied: 0.5 ml or 0.5 g, not specified
- Postexposure period: 72 hours
- Removal of test substance: after 24 hours
EXAMINATIONS
- Scoring system: Primary irritation indices from 1 to 4;
sum of intact and abraded scores included
- Examination time points: 24 and 72 hours
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 80 wt% Sodium Silicate. Molar ratio
3.3. The article does not specify whether the substance was
a dry powder or a liquid. Powders were moistened with
physiological saline before application of 0.5 g, while
liquids were applied directly in 0.5 ml doses.
(4) not assignable
Only secondary literature available (review).
(50)
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
36 other: wt%
Occlusive
24 hour(s)
3
moderately irritating
Method:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
119
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
43 other: wt%
Occlusive
24 hour(s)
3
moderately irritating
Method:
Reliability:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
rabbit
37 other: wt%
Occlusive
Result:
Test condition:
Test substance:
Reliability:
120
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Exposure Time:
PDII:
Result:
24 hour(s)
3
moderately irritating
Method:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
24 other: wt%
Occlusive
24 hour(s)
4
irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
121
OECD SIDS
5. TOXICITY
Result:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
99 other: wt%
Occlusive
24 hour(s)
8
corrosive
Method:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
122
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
54 other: wt%
Occlusive
24 hour(s)
4
irritating
Method:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
06-FEB-2003
123
OECD SIDS
5. TOXICITY
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
8 other: wt%
Occlusive
24 hour(s)
4
irritating
Method:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
43 other: wt%
Occlusive
4 hour(s)
3.3
moderately irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
124
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
37 other: wt%
Occlusive
4 hour(s)
0
not irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
125
OECD SIDS
5. TOXICITY
06-FEB-2003
- Occlusion: yes
- Vehicle: none
- Concentration in vehicle: not relevant
- Total volume applied: 0.5 ml or 0.5 g, not specified
- Postexposure period: 72 hours
- Removal of test substance: after 4 hours
EXAMINATIONS
- Scoring system: Primary irritation indices from 1 to 4;
sum of intact and abraded scores included
- Examination time points: 24 and 72 hours
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 37 wt% Sodium Silicate. Molar ratio
2.6. The article does not specify whether the substance was
a dry powder or a liquid. Powders were moistened with
physiological saline before application of 0.5 g, while
liquids were applied directly in 0.5 ml doses.
(4) not assignable
Only secondary literature available (review).
(50)
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
47 other: wt%
Occlusive
4 hour(s)
4.2
irritating
Method:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
126
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
44 other: wt%
Occlusive
4 hour(s)
4.2
irritating
Method:
Reliability:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
rabbit
54 other: wt%
Occlusive
4 hour(s)
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
127
OECD SIDS
5. TOXICITY
PDII:
Result:
4.7
irritating
Method:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
38 other: wt%
Occlusive
4 hour(s)
3.2
moderately irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
128
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
Result:
rabbit
51 other: wt%
Occlusive
4 hour(s)
corrosive
Method:
Result:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
129
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
rabbit
61 other: wt%
Occlusive
4 hour(s)
Method:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
130
OECD SIDS
5. TOXICITY
Reliability:
06-FEB-2003
(50)
Species:
Concentration:
Exposure:
Exposure Time:
Result:
rabbit
90 other: wt%
Occlusive
4 hour(s)
corrosive
Method:
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
82 %
Semiocclusive
4 hour(s)
3
4.6
corrosive
Method:
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
131
OECD SIDS
5. TOXICITY
Year:
GLP:
Test substance:
1984
yes
other TS
Method:
Flag:
25-NOV-2003
Species:
human
Result:
Test condition:
Test substance:
Reliability:
132
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
Result:
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
133
OECD SIDS
5. TOXICITY
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
Result:
human
34.9 other: wt%
Semiocclusive
4 hour(s)
20
water
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Reliability:
Result:
Test condition:
134
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
25-NOV-2003
Species:
No. of Animals:
Result:
Method:
Year:
Test substance:
other
1973
other TS
Method:
Test substance:
Reliability:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
135
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
Vehicle:
Result:
Method:
Year:
GLP:
Test substance:
Method:
Reliability:
Result:
Test condition:
136
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
- Vehicle: water
- Concentration in vehicle: Not applicable
- Total volume applied: 0.3 ml
- Removal of test substance: with warm water
- Number of discs: 3
IN VITRO TEST SYSTEM:
- Test conditions: Animals were anaesthesized (3% Fluothane)
and the dorsal and flank hair carefully removed using fine
clippers. Epidermal slices were not prepared from animals
until at least 48 hrs after hair clipping. Animals were
killed humanly and the dorsal skin was removed as a single
pelt. Excess fat was cut away and the remaining skin was
placed over a cork saddle. Epidermal slices (18 mm x 80 mm)
were cut and placed , stratum corneum uppermost, over a
rubber 'O' ring. The epidermal slice attached to the PTFE
tube was suspended in physiological saline and maintained at
ambient temperature (appr. 20C).
Each test chemical was placed onto thestratum corneum. After
required skin contact the chemical was removed with a jet of
warm water (40-45C) immediately prior to measuring
electrical resistance across the skin slice.
EXAMINATIONS:
- Scoring system: Electrical resistance over the skin was
measured. Resistance < 4 kOhm.disc (3.2 kOhm.cm2) was
regarded as positive with respect to corrosive properties.
- Examination time points: 1 or 4 hrs.
SOURCE: Imperial Chemical Industries
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Sodium Silicate 52 wt%. pH 13.6,
viscous liquid, molar ratio 1.6
(2) valid with restrictions
Comparable to guideline study.
(42)
Species:
Exposure:
Exposure Time:
Vehicle:
Result:
rat
Open
4 hour(s)
water
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
137
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
Vehicle:
Result:
rat
44 other: wt%
Open
24 hour(s)
water
corrosive
Method:
Test condition:
Test substance:
Reliability:
138
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Year:
GLP:
Test substance:
1988
no
other TS
Method:
Result:
Test condition:
UNEP PUBLICATIONS
139
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
Vehicle:
Result:
rat
38 other: wt%
Open
24 hour(s)
water
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
140
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
06-FEB-2003
rabbit
36 other: wt%
not irritating
Method:
141
OECD SIDS
5. TOXICITY
GLP:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
1 minute(s)
highly irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
142
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
143
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
Species:
Concentration:
Result:
rabbit
43 other: wt%
highly irritating
Method:
Reliability:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Result:
rabbit
8 other: wt%
irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
Test substance:
Method:
Result:
Test condition:
144
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Concentration:
Result:
rabbit
44 other: wt%
highly irritating
Method:
Test substance:
Reliability:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Result:
rabbit
6 other: wt%
irritating
Method:
Result:
Test condition:
Test substance:
Reliability:
Test substance:
Method:
Result:
145
OECD SIDS
5. TOXICITY
Test condition:
06-FEB-2003
Species:
Concentration:
Result:
rabbit
3 other: wt%
irritating
Method:
Test substance:
Reliability:
Test substance:
Method:
06-FEB-2003
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
1 minute(s)
highly irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
146
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
Test condition:
147
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
with saline.
EXAMINATIONS
- Opacification of the cornea (macroscopic and microscopic
[with a Zeiss slit lamp] appearance): after treatment, 30
minutes, 1, 2, 3 and 4 hrs after treatment.
- Corneal thickness with a Zeiss lamp: prior to and after
treatment, 30 minutes, 1, 2, 3 and 4 hrs after treatment.
- Rate fluorescein diffusion into corneal stroma together
with possible corneal damage using slit lamp.
- Histological assessment after dissection eyes.
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 2.4, white powder
(4) not assignable
The method is well-documented, but not yet validated. It is
currently in use as an alternative to in vivo eye irritation
studies for substances which are shown to be irritating in
skin irritation tests.
Critical study for SIDS endpoint
(62) (64)
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
1 minute(s)
irritating
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
148
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
149
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
1 minute(s)
moderately irritating
Method:
Year:
GLP:
Test substance:
Method:
Reliability:
Result:
Test condition:
150
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
Species:
Concentration:
Dose:
Exposure Time:
Result:
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
UNEP PUBLICATIONS
151
OECD SIDS
5. TOXICITY
Result:
Test condition:
152
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
EXAMINATIONS
- Opacification of the cornea (macroscopic and microscopic
appearance): after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Corneal thickness and appearance slit image of the corneal
surface: after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Rate fluorescein diffusion into the corneal stroma using
slit lamp
- Histological assessment after dissection eyes
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: Not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 3.0, white powder
(4) not assignable
The method is well-documented, but not yet validated. It is
currently in use as an alternative to in vivo eye irritation
studies for substances which are shown to be irritating in
skin irritation tests.
Critical study for SIDS endpoint
(62) (64)
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
1 minute(s)
slightly irritating
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
153
OECD SIDS
5. TOXICITY
Test condition:
Flag:
26-JAN-2004
TEST ANIMALS:
- Strain: Not reported
- Sex: Not reported
- Source: Laboratories of Industrial Toxicology, Huntingdon
Research Centre Ltd. (HRC)
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animal eyes: 3
- Controls: yes, 2 enucleated eyes served as control
The eyes were from animals used by HRC in skin irritation
tests or were the control eyes from eye irritation tests.
ADMINISTRATION/EXPOSURE
- Preparation of test substance: applied directly as a
water-soluble powder to the corneal surface.
- Amount of substance instilled: 50 mg
- Vehicle: None
- Postexposure period: No
IN VITRO TEST SYSTEM
- Test conditions: the eyes were wetted with saline and
humidity maintained by a quantity of freestanding distilled
water (37C) in the bottom of the flask. At the testing
laboratory the eyes were placed in superfusion chambers.
Immediately after the eyes were positioned in the chamber
the eyes were stained with 1% Fluorescein for 10 seconds to
establish if there was any damage. The corneal thickness of
each eye was then measured and left for 60 minutes to allow
the eyes to eliquibrate. Then the test sample was applied to
the corneal surface of each eye for 1 minute and then rinsed
with saline.
EXAMINATIONS
- Opacification of the cornea (macroscopic and microscopic
appearance): after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Corneal thickness and appearance slit image of the corneal
surface: after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Rate fluorescein diffusion into corneal stroma using slit
lamp
- Histological assessment after dissection eyes
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: Not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 3.3, white powder
(4) not assignable
The method is well-documented, but not yet validated. It is
currently in use as an alternative to in vivo eye irritation
studies for substances which are shown to be irritating in
skin irritation tests.
Critical study for SIDS endpoint
(62) (64)
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
.17 minute(s)
irritating
Test substance:
Reliability:
154
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
UNEP PUBLICATIONS
155
OECD SIDS
5. TOXICITY
26-JAN-2004
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
.17 minute(s)
irritating
Method:
Year:
GLP:
Method:
Test substance:
Reliability:
Result:
156
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
26-JAN-2004
loss)
TEST ANIMALS:
- Strain: Not reported
- Sex: Not reported
- Source: Laboratories of Industrial Toxicology, Huntingdon
Research Centre Ltd. (HRC)
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animal eyes: 3
- Controls: yes, 2 enucleated eyes served as control
The eyes were from animals used by HRC in skin irritation
tests or were the control eyes from eye irritation tests.
ADMINISTRATION/EXPOSURE
- Preparation of test substance: applied directly as a
water-soluble powder to the corneal surface.
- Amount of substance instilled: 50 mg
- Vehicle: None
- Postexposure period: No
IN VITRO TEST SYSTEM
- Test conditions: the eyes were wetted with saline and
humidity maintained by a quantity of freestanding distilled
water (37C) in the bottom of the flask. At the testing
laboratory the eyes were placed in superfusion chambers.
Immediately after the eyes were positioned in the chamber
the eyes were stained with 1% Fluorescein for 10 seconds to
establish if there was any damage. The corneal thickness of
each eye was then measured and left for 60 minutes to allow
the eyes to eliquibrate. Then the test sample was applied to
the corneal surface of each eye for 1 minute and then rinsed
with saline.
EXAMINATIONS
- Opacification of the cornea (macroscopic and microscopic
appearance): after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Corneal thickness and appearance slit image of the corneal
surface: after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Rate fluorescein diffusion into corneal stroma using slit
lamp
- Histological assessment after dissection eyes
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: Not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 1.6, white powder
(4) not assignable
The method is well-documented, but not validated. There are
no guidelines for this kind of study, but the protocol is in
use as an alternative to in vivo eye irritation studies for
substances which are shown to be skin irritating/corrosive
in in vivo studies.
(63)
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
.17 minute(s)
irritating
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
157
OECD SIDS
5. TOXICITY
Method:
Year:
GLP:
Method:
Result:
Test condition:
158
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
26-JAN-2004
with saline.
EXAMINATIONS
- Opacification of the cornea (macroscopic and microscopic
appearance): after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Corneal thickness and appearance slit image of the corneal
surface: after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Rate fluorescein diffusion into corneal stroma using slit
lamp
- Histological assessment after dissection eyes
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: Not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 1.8, white powder
(4) not assignable
The method is well-documented, but not validated. There are
no guidelines for this kind of study, but the protocol is in
use as an alternative to in vivo eye irritation studies for
substances which are shown to be skin irritating/corrosive
in in vivo studies.
(63)
Species:
Concentration:
Dose:
Exposure Time:
Result:
rabbit
undiluted
50 other: mg
.17 minute(s)
irritating
Method:
Year:
GLP:
Method:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
159
OECD SIDS
5. TOXICITY
26-JAN-2004
swelling
and/or 5-6 corneal cell layers loss/ Severe: moderate/severe
opacity and/or > 35% swelling and/or 7-8 corneal cell layers
loss)
TEST ANIMALS:
- Strain: New Zealand White
- Sex: Not reported
- Source: Laboratories of Industrial Toxicology, Huntingdon
Research Centre Ltd. (HRC)
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animal eyes: 3
- Controls: yes, 1 untreated eye served as control
The eyes were from animals used by HRC in skin irritation
tests or were the control eyes from eye irritation tests.
ADMINISTRATION/EXPOSURE
- Preparation of test substance: applied directly as
awater-soluble powder to the corneal surface.
- Amount of substance instilled: 50 mg
- Vehicle: None
- Postexposure period: No
IN VITRO TEST SYSTEM
- Test conditions: the eyes were wetted with saline and
humidity maintained by a quantity of freestanding distilled
water (37C) in the bottom of the flask. At the testing
laboratory the eyes were placed in superfusion chambers.
Immediately after the eyes mounted in clamps and placed
under saline drip in cells in the maintenance chamber, the
eyes were stained with 1% Fluorescein for 10 seconds to
establish if there was any damage. The corneal thickness of
each eye was then measured and left for 60 minutes to allow
the eyes to eliquibrate. Then the test sample was applied to
the corneal surface of each eye for 10 seconds and then
rinsed with saline.
EXAMINATIONS
- Opacification of the cornea (macroscopic [with a Zeiss
slit lamp] after treatment, 30 minutes, 1, 2, 3 and 4 hrs
after treatment.
- Corneal thickness (with a Zeiss slit lamp) after
treatment, 30 minutes, 1, 2, 3 and 4 hrs after treatment
- Rate fluorescein diffusion into corneal stroma using slit
lamp
- Histological assessment after dissection eyes
- Scoring system: Unilever enucleated eye grading
- Observation period: after treatment, 30 minutes, 1, 2, 3,
4 hours after treatment
- Tool used to assess score: Not reported
SOURCE: Not reported
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio of 2.0, white powder
(4) not assignable
The method is well-documented, but not validated. There are
no guidelines for this kind of study, but the protocol is in
use as an alternative to in vivo eye irritation studies for
substances which are shown to be skin irritating/corrosive
in in vivo studies.
(63)
Species:
Exposure Time:
rabbit
unspecified
Test condition:
Test substance:
Reliability:
160
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
GLP:
Test substance:
no
other TS
Remark:
Reliability:
06-FEB-2003
SiO2/Na2O
Concentration
results
wt ratio
+ = corrosive
3.2
5 % w/v
3.2
10% w/v
-,2.9
10% w/v
2.9
15% w/v
+
2.9
neat liq (43%)
+
2.4
10% v/v
2.4
15% v/v
+
2.4
neat pwd.
+,2.0
5%
v/v
2.0
10% v/v
+,+
2.0
neat pwd.
+,0.7
10% w
+
(4) not assignable
Only secondary literature available (review).
(50)
5.3 Sensitization
Remark:
06-FEB-2003
5.4 Repeated Dose Toxicity
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Doses:
Control Group:
Sub-acute
rat
Sex: male/female
other: Charles River Cesarean-Derived (CD)
oral feed
4 weeks
daily
2400 mg/kg bw/d
yes
Method:
Year:
GLP:
Test substance:
Method:
161
OECD SIDS
5. TOXICITY
Result:
Test condition:
Test substance:
162
OECD SIDS
5. TOXICITY
Reliability:
Flag:
08-MAY-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
NOAEL:
Sub-chronic
rat
Sprague-Dawley
drinking water
180 d
daily
no
600 and 1200 mg SiO2/l
yes
> 159 mg/kg bw
Sex: male/female
Year:
GLP:
Test substance:
1973
no
other TS
Method:
Result:
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5. TOXICITY
Test condition:
TEST ORGANISMS
- Age: Weanling
- Weight at study initiation: Not reported
- Number of animals: 6/sex/dose
ADMINISTRATION / EXPOSURE
- Duration of test/exposure: 180 (m-f) + 17 days (m)
- Type of exposure: oral via drinking water. All animals
were maintained on a normal diet which contained 0.15 to
1.0% of SiO2 (based on dry weight).
- Post exposure period: no
- Vehicle: drinking water
- Concentration in vehicle: not reported
- Doses: 600 and 1200 mg SiO2/l corresponding to 789.5 and
1587 mg sodium silicate/l
SATELLITE GROUPS AND REASONS THEY WERE ADDED: None
CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: Not reported
- Mortality: registered with unknown frequency
- Body weight: registered every week
- Food consumption: Not reported
- Water consumption: Not reported
- Ophthalmoscopic examination: Not reported
- Haematology: Not reported
- Biochemistry: Not reported
- Urinalysis: nitrogen and phosphorous registered daily from
day 181-197 in males
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopic: Not reported
- Microscopic: Not reported
OTHER EXAMINATIONS: Analysis of faeces: nitrogen and
phosphorous registered daily from day 181-197 in males
STATISTICAL METHODS: Not reported
Test substance:
SOURCE: Diamond Alkali Company, Cleveland, Ohio, USA
PURITY: Not indicated
IMPURITY/ADDITIVE/ETC.: Not indicated
ANY OTHER INFORMATION: Molar ratio 3.2. Background
concentration in the diet varied between 0.1 and 1.0% of
SiO2 (w/w). Test substance Sodium Silicate was used.
Reliability:
(2) valid with restrictions
Only two standard parameters were studied: body weight and
survival. Background concentration in the diet varied
between 0.1 and 1.0% of SiO2 (w/w). Nitrogen and phosphorous
retention/excretion was measured only in the males at the
end of the exposure period.
Flag:
Critical study for SIDS endpoint
28-NOV-2003
(54)
Type:
Sub-acute
Species:
dog
Sex: male/female
Strain:
other: Beagle
Route of administration: oral feed
Exposure period:
4 weeks
Frequency of treatment: daily
Doses:
2400 mg/kg bw/d
Control Group:
yes
Method:
Year:
GLP:
Test substance:
Method:
164
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5. TOXICITY
Result:
Test condition:
165
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
Flag:
08-MAY-2003
Method:
Year:
GLP:
Test substance:
other
1951
no
other TS
Method:
Remark:
Result:
Test condition:
166
OECD SIDS
5. TOXICITY
Result:
GENOTOXIC EFFECTS:
- With metabolic activation: no biologically relevant
increases in chromosomal aberrations and frequencies of
polyploid metaphases
- Without metabolic activation: no biologically relevant
increases in chromosomal aberrations and frequencies of
polyploid metaphases
PRECIPITATION CONCENTRATION: 156.3 g active ingredient/ml
(except experiment II after 18h preparation interval without
S9 mix where precipitation occurred at 78.1 g/ml and above)
CYTOTOXIC CONCENTRATION:
- With metabolic activation: 312.5 g active ingredient/ml
- Without metabolic activation: 156.3 g active ingredient/ml
CELL CULTURE DETAILS:
- Type and identity of media: Minimal Essential Medium
supplemented with 10% fetal calf serum.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
Test condition:
SYSTEM OF TESTING
- Species/cell type: Chinese hamster lung fibroblasts (V79)
- Metabolic activation system: Phenobarbital /
-Naphthoflavone induced rat liver S9-mix
- Exposure duration, recovery period, total preparation
interval:
without S9 Mix
with S9 Mix
Exp. I
Exp. II
Exp. I
Exp. II
------------------------------------------------------Exposure
4h
18h 28h
4h
4h
Recovery
14h
14h
24h
------------------------------------------------------Total
18h
18h 28h
18h
28h
- Spindle inhibitor: 0.2 g/ml Colcemid
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5. TOXICITY
Test substance:
Reliability:
Flag:
05-APR-2006
ADMINISTRATION:
- Dosing: Cytotoxic concentrations were determined in a
range-finder study with and without metabolic activation.
312.5 g/ml was chosen as top concentration in the actual
experiments.
- Number of replicates: 2
- Application:
- Positive and negative control groups and treatment: 300-400
g/ml Ethylmethane sulfonate (-S9), 1.4-2.0 g/ml
Cyclophosphamide (+S9) and Minimal Essential Medium
- Pre-incubation time:
DESCRIPTION OF FOLLOW UP REPEAT STUDY:
CRITERIA FOR EVALUATING RESULTS: Breaks, fragments, deletions,
exchanges, and chromosome disintegrations were recorded as
structural chromosome aberrations. Gaps were recorded as well,
but not included in the calculation of aberration rates. Only
metaphases with characteristic chromosome numbers (22+-1) were
included in the analysis. The mitotic index (% cells in
mitosis) and the percentage of polyploid cells in 500
metaphase plates/culture were determined.
CAS 1344-09-8
Sodium silicate solution (weight ratio 3.3)
Tradename: Natronwasserglas 37/40 PE
36% active ingredient, 64% water
(1) valid without restriction
Critical study for SIDS endpoint
(51)
1973
no
other TS
METHOD FOLLOWED: Rats were treated with 0, 600 and 1200 mg
SiO2/l drinking water from weaning age (3 weeks) to maturity
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
35%
UNEP PUBLICATIONS
24%
11%
169
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
14-JUL-2003
170
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OECD SIDS
5. TOXICITY
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
171
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5. TOXICITY
Reliability:
Flag:
06-MAR-2003
Type:
In Vitro/in vivo:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Duration of test:
Doses:
Control Group:
Result:
Remark:
Reliability:
Flag:
28-NOV-2003
Remark:
Reliability:
Flag:
28-NOV-2003
Type:
In Vitro/in vivo:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Duration of test:
Doses:
Control Group:
Result:
(25)
(40)
other
Remark:
Test substance:
172
OECD SIDS
5. TOXICITY
Reliability:
29-MAR-2005
(50) (52)
Type of experience:
Remark:
Test substance:
Reliability:
Flag:
21-NOV-2003
Type of experience:
Remark:
Reliability:
Flag:
21-NOV-2003
Type of experience:
Remark:
Test substance:
Test substance:
Reliability:
Flag:
21-NOV-2003
UNEP PUBLICATIONS
173
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5. TOXICITY
21-NOV-2003
174
(43)
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
175
OECD SIDS
6. REFERENCES
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
177
OECD SIDS
6. REFERENCES
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
RI930472.
(64) York M, Wilson AP and Newsome CS (1994). The classification
of soluble silicates for eye hazard using the enucleated
rabbit eye test. Toxic. in Vitro 8, 1265-1268.
UNEP PUBLICATIONS
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Existing Chemical
CAS No.
EINECS Name
EC No.
TSCA Name
Molecular Formula
ID: 6834-92-0
6834-92-0
disodium metasilicate
229-912-9
Silicic acid (H2SiO3), disodium salt
H2O3Si.2Na
Printing date:
Revision date:
Date of last Update:
03-FEB-2005
Number of Pages:
104
03-FEB-2005
Chapter (profile):
Chapter: 1, 2, 3, 4, 5
Reliability (profile): Reliability: without reliability, 1, 2, 3, 4
Flags (profile):
Flags: without flag, confidential, non confidential, WGK
(DE), TA-Luft (DE), Material Safety Dataset, Risk
Assessment, Directive 67/548/EEC, SIDS
180
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1. GENERAL INFORMATION
lead organisation
Centre Europeen d'Etude des Silicates (CEES)
Jol Wilmot
Date: 28-FEB-2003
Av. E van Nieuwenhuyse, 4
B-1160 Bruxelles
Belgium
+32 26767288
+32 26767347
[email protected]
http://www.cees-silicates.org
Remark:
23-JAN-2004
04-DEC-2003
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1. GENERAL INFORMATION
Remark:
23-JAN-2004
1.1.2 Spectra
1.2 Synonyms and Tradenames
Disodium metasilicate
Remark:
13-NOV-1995
Disodium monosilicate
Remark:
13-NOV-1995
Disodium silicate
Remark:
13-NOV-1995
Na2SiO3
Remark:
12-NOV-2002
Na2SiO3 . 5H2O
Remark:
12-DEC-2003
Na2SiO3 . 9H2O
182
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1. GENERAL INFORMATION
Remark:
12-DEC-2003
1.3 Impurities
Purity type:
Remark:
Impurities stem from the quartz sand used rather than from
soda. Therefore, impurities of potassium silicates are
similar to sodium silicates of comparable molar ratios. The
following impurities were reported for sodium silicate lumps
of weight ratio 3.35 (molar ratio 3.46):
Na2SO4: 0.06%
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183
OECD SIDS
1. GENERAL INFORMATION
Reliability:
Flag:
03-DEC-2003
NaCl: 0.06%
Fe2O3: 0.033%
Al2O3: 0.097%
CaO: 0.03%
MgO: 0.02%
TiO2: 0.019%
(4) not assignable
Review article only
Critical study for SIDS endpoint
(12)
Purity type:
Remark:
Result:
Reliability:
Flag:
03-DEC-2003
1.4 Additives
Remark:
Reliability:
Quantity
(4) not
Handbook
Critical
Flag:
04-DEC-2003
184
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1. GENERAL INFORMATION
1.6.1 Labelling
Labelling:
Symbols:
Specific limits:
R-Phrases:
S-Phrases:
as in Directive 67/548/EEC
(C) corrosive
no
(34) Causes burns
(37) Irritating to respiratory system
(1/2) Keep locked up and out of reach of children
(13) Keep away from food, drink and animal feeding stuffs
(24/25) Avoid contact with skin and eyes
(36/37/39) Wear suitable protective clothing, gloves and
eye/face protection
(45) In case of accident or if you feel unwell, seek medical
advice immediately (show the label where possible)
23-JAN-2004
1.6.2 Classification
1.6.3 Packaging
1.7 Use Pattern
Type:
Category:
type
Wide dispersive use
05-FEB-2003
Type:
Category:
industrial
Personal and domestic use
05-FEB-2003
Type:
Category:
industrial
Public domain
05-FEB-2003
Type:
Category:
use
Cleaning/washing agents and disinfectants
Remark:
Automatic dish-washing powders and technical cleaners where
high alkalinity is needed.
15-DEC-2003
(8) (14) (34) (52)
Type:
Category:
use
Corrosive inhibitors
15-DEC-2003
Type:
Category:
(8)
use
Non agricultural pesticides
15-DEC-2003
Type:
Category:
(8)
use
Photochemicals
15-DEC-2003
(8)
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1. GENERAL INFORMATION
Type:
Category:
use
Reprographic agents
15-DEC-2003
Type:
Category:
(8)
use
other: Anti-freezing agents
15-DEC-2003
Type:
Category:
(8)
use
other: car-care product
15-DEC-2003
(52)
16-DEC-2003
KBwS (DE)
1 (weakly water polluting)
Reliability:
08-JAN-2004
(17)
186
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1. GENERAL INFORMATION
21-OCT-2004
Source of exposure: Human: exposure through intended use
Exposure to the:
Substance
Remark:
21-OCT-2004
21-OCT-2004
21-OCT-2004
Source of exposure: Environment: exposure through private use
Exposure to the:
Substance
Remark:
21-OCT-2004
1.11 Additional Remarks
1.12 Last Literature Search
1.13 Reviews
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2. PHYSICO-CHEMICAL DATA
1089 degree C
no
Method:
GLP:
other: no data
no data
Remark:
Flag:
30-SEP-2004
Value:
Sublimation:
72.2 degree C
no
Method:
GLP:
other: no data
no data
Test substance:
Reliability:
Flag:
30-SEP-2004
Value:
48 degree C
Test substance:
Reliability:
Test substance:
Reliability:
Flag:
19-OCT-2004
(3)
Value:
Sublimation:
47.9 degree C
no
Method:
GLP:
other: no data
no data
Test substance:
Reliability:
19-OCT-2004
2.2 Boiling Point
Value:
100 degree C
Test substance:
Reliability:
188
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
16-DEC-2003
(30)
Value:
Remark:
30-SEP-2004
2.3 Density
Type:
Value:
density
2.61 g/cm
Test substance:
Reliability:
Flag:
30-SEP-2004
(3)
Type:
Value:
bulk density
1200 kg/m3
Test substance:
Reliability:
Flag:
20-OCT-2004
(34)
Type:
Value:
density
1.75 g/cm at 20 degree C
Test substance:
Reliability:
Flag:
19-OCT-2004
Type:
Value:
bulk density
1000 kg/m3
Test substance:
Reliability:
Flag:
20-OCT-2004
(34)
Type:
Value:
density
1.65 g/cm at 20 degree C
Test substance:
Reliability:
189
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Flag:
19-OCT-2004
Type:
Value:
bulk density
800 kg/m3
Test substance:
Reliability:
Flag:
20-OCT-2004
(34)
2.3.1 Granulometry
2.4 Vapour Pressure
Value:
Method:
GLP:
Remark:
Test substance:
Reliability:
Flag:
08-JAN-2004
(28)
Remark:
Reliability:
Flag:
19-OCT-2004
Remark:
Reliability:
Flag:
20-OCT-2004
190
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2. PHYSICO-CHEMICAL DATA
Remark:
Flag:
30-SEP-2004
Solubility in:
Value:
pH
value:
Conc.:
Water
= 210 g/l at 20 degree C
12.7
1 vol% degree C
Test substance:
Reliability:
Test substance:
Reliability:
Flag:
21-OCT-2004
(43)
Solubility in:
Value:
Water
= 610 g/l at 30 degree C
Test substance:
Reliability:
Flag:
21-OCT-2004
Remark:
(44)
30-SEP-2004
Solubility in:
Value:
Water
115 mg/l at 25 degree C
Remark:
Flag:
30-SEP-2004
pH
10 - 13
Test substance:
Reliability:
Reliability:
value:
Remark:
Reliability:
191
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Flag:
19-OCT-2004
Remark:
Reliability:
(5)
21-OCT-2004
(34)
2.9 Flammability
Result:
non flammable
Remark:
not explosive
Remark:
Reliability:
21-OCT-2004
no oxidizing properties
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Remark:
Reliability:
21-OCT-2004
UNEP PUBLICATIONS
193
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
3.1.1 Photodegradation
Remark:
Reliability:
26-JAN-2004
Remark:
Reliability:
18-DEC-2003
Remark:
Reliability:
18-DEC-2003
Polymerisation-Depolymerisation:
Upon dilution of concentrated commercial silicate solutions
with water, the highly cross-linked polysilicate ions
depolymerize rapidly to monosilicate ions, the extent of
depolymerisation depending on the dilution factor.
(2) valid with restrictions
Acceptable procedure and publication
(37)
The basic consideration is that silica dissolves according
to : SiO2 + H2O = Si(OH)4. At low concentrations most
species are present as monomers, at higher concentrations
polymerisation will occur.
Most soluble silicates are in the form:
M2O . mSiO2 . nH2O
where M = alkali metal, predominantly Na, but also K. The
index m (molar ratio) ranges between 0.5 - 4, most commonly
m = 3.3. Stability depends to a large extent on pH, above pH
10.6 the solutions are chemically stable. The increase of
ionic strength accelerates nucleation and deposition and
decreases the SiO2 solubility. Coating of surfaces by
organic matter may hamper dissolution, but at the same time
Si(OH)4 may form complexes with organic matter, a process
which favours dissolution.
(4) not assignable
Handbook data
(13)
UNEP PUBLICATIONS
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Medium:
Remark:
Reliability:
Flag:
18-DEC-2003
Reliability:
195
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Flag:
18-DEC-2003
Remark:
SiO2 enters surface waters via the four main application areas
where emissions to water systems might occur (household
detergents, pulp-and paper production, water treatment, and
soil stabilisation).
Seen in the context of the natural silica cycle, and natural
loading of water systems with silicates due to weathering of
soil and rocks, weathering of sediments and atmospheric
deposition, this amount is small.
(2) valid with restrictions
Well-documented scientific publication.
Critical study for SIDS endpoint
(48) (54)
Reliability:
Flag:
18-DEC-2003
(13) (20)
Reliability:
19-DEC-2003
3.3.2 Distribution
Remark:
18-DEC-2003
Remark:
Reliability:
18-DEC-2003
UNEP PUBLICATIONS
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Method:
Remark:
Reliability:
18-DEC-2003
3.7 Bioaccumulation
Remark:
Reliability:
Flag:
19-DEC-2003
Remark:
Reliability:
08-JAN-2004
UNEP PUBLICATIONS
197
OECD SIDS
4. ECOTOXICITY
AQUATIC ORGANISMS
4.1 Acute/Prolonged Toxicity to Fish
Type:
Species:
Exposure period:
Unit:
LC0:
LC50:
LC100:
semistatic
other: Brachydanio rerio (now Danio rerio)
96 hour(s)
mg/l
Analytical monitoring: no
= 180
= 210
= 250
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
198
UNEP PUBLICATIONS
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4. ECOTOXICITY
Flag:
30-SEP-2004
Type:
Species:
Exposure period:
Unit:
LC50:
static
Gambusia affinis
96 hour(s)
mg/l
2320
Method:
Year:
GLP:
Test substance:
other
1957
no
other TS
Method:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
199
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
Flag:
30-SEP-2004
Method:
Year:
GLP:
Result:
Test condition:
200
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
03-FEB-2005
aquatic
activated sludge, domestic
3 hour(s)
mg/l
Analytical monitoring: no
> 100
Method:
Year:
GLP:
Test substance:
Method:
201
OECD SIDS
4. ECOTOXICITY
Flag:
25-NOV-2003
GLP: yes
STATISTICAL METHODS: Finney's probit method for the
estimation of the EC50 after 3 hours of the reference
substance only
METHOD OF CALCULATION: Not reported
ANALYTICAL METHODS: Not reported as no analysis required
RESULTS: EXPOSED
- Nominal/measured concentrations: 0-100 mg test substance/l
(nominal)
- Effect data (Mortality): No significant inhibition of
respiration at 100 mg test substance/l
- Concentration / response curve: not relevant, as no
significant inhibitory effect
- Effect concentration vs. test substance solubility: not
relevant, as no significant inhibitory effect
- Other effects: not reported
RESULTS: CONTROL
- Number/percentage of animals showing adverse effects: 1%
respiration inhibition at 100 mg/l
- Nature of adverse effects: not relevant, as no significant
inhibitory effect
RESULTS: TEST WITH REFERENCE SUBSTANCE
- Concentrations: 5,15 and 30 mg/l dichlorophenol
- Results: EC50 (3 hours) 9.8 mg/l
TEST ORGANISMS
- Strain: a mixture of different strains of micro-organisms
(inoculum) found in activated sludge
- Supplier: activated sludge from a sewage treatment plant
treating predominantly domestic sewage (Pierre
Benite-F-69310 Lyon)
- Age/size/weight/loading: the sludge was used 24 hours
after collecting the sample, and had 1600 mg suspended
solids/l.
DILUTION WATER
- Source: distilled water
TEST SYSTEM
- Concentrations: 1,10, 50 and 100 mg test substance/l
- Exposure vessel type: 1000 ml beakers with covers
- Test temperature: 17.7-20.2 C
- Dissolved oxygen:continuous aeration and continuous
magnetic stirring
- pH: ranged from 6.56-8.95 at start of study and 5.96-8.07
at end of study
DURATION OF THE TEST: 3 hours
SOURCE: Rhone-Poulenc Chimie
PURITY: 100% active matter
IMPURITY/ADDITIVE/ETC.: not reported
ANY OTHER INFORMATION: Sodium Metasilicate (anhydrous). Test
substance described as SIMET AP. Reported in the certificate
of analysis: rejected on 80 mm sieve, 0.1 bulk density 1.15,
whiteness 93.15
(2) valid with restrictions
Guideline study, but no information on purity of test
substance.
Critical study for SIDS endpoint
(4)
Type:
Species:
Exposure period:
Unit:
aquatic
Pseudomonas putida
30 minute(s)
mg/l
Result:
Test condition:
Test substance:
Reliability:
202
(Bacteria)
Analytical monitoring: no data
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
EC0:
= 1000
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Flag:
25-FEB-2003
UNEP PUBLICATIONS
203
OECD SIDS
4. ECOTOXICITY
204
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Reliability:
21-NOV-2003
Result:
Reliability:
21-NOV-2003
LD50
rat
Wistar
male
no data
no data
1750 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1971
no
other TS
UNEP PUBLICATIONS
205
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5. TOXICITY
Method:
05-FEB-2003
Type:
Species:
Strain:
Sex:
No. of Animals:
Vehicle:
Doses:
Value:
LD50
rat
Wistar
male/female
110
no data
538-2000 (males), 910-2600 (females)
1152 - 1349 mg/kg bw
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
206
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
05-FEB-2003
Type:
Species:
Strain:
Sex:
Vehicle:
Doses:
Value:
LD50
mouse
other:ddy
male/female
no data
500-1920.8 mg/kg (males), 500-1372 mg/kg (females)
770 - 820 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Test condition:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
207
OECD SIDS
5. TOXICITY
Flag:
05-FEB-2003
Type:
Species:
Value:
LD50
rat
= 800 mg/kg bw
Method:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
208
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
Test condition:
Test substance:
Reliability:
05-FEB-2003
Type:
Species:
Value:
LD50
rat
= 600 mg/kg bw
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
05-FEB-2003
Type:
Species:
Sex:
Vehicle:
Value:
LD50
mouse
male
no data
= 1200 - 1700 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1973
no
other TS
Method:
(48)
(48)
209
OECD SIDS
5. TOXICITY
rabbit
10 other:wt%
Occlusive
24 hour(s)
5,6
corrosive
Method:
GLP:
Test substance:
Method:
Result:
210
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
05-FEB-2003
Species:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
Semiocclusive
4 hour(s)
1
water
8
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
211
OECD SIDS
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Flag:
25-NOV-2003
- Controls: no
ADMINISTRATION/EXPOSURE
- Preparation of test substance: moistened before
application with distilled water
- Area of exposure: intact skin (shaved)
- Occlusion: semiocclusive
- Vehicle: distilled water
- Concentration in vehicle: not applicable
- Total volume applied: 0.5 g
- Postexposure period: 5 days
- Removal of test substance: yes (washed away with water)
IN VITRO TEST SYSTEM: Not relevant
EXAMINATIONS
- Scoring system: skin irritation index according to OECD
404
- Examination time points: 1, 24, 48, 72 hours and 5 days
SOURCE: EKA Kemi AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Sodium metasilicate (anhydrous).
Applied as moistened substance (concentration not indicated).
(2) valid with restrictions
Guideline study, but no information on purity of test
substance.
Critical study for SIDS endpoint
(7)
Species:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
Semiocclusive
4 hour(s)
1
water
8
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
212
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
- Controls: no
ADMINISTRATION/EXPOSURE
- Preparation of test substance: moistened before
application with distilled water
- Area of exposure: intact skin (shaved)
- Occlusion: semiocclusive
- Vehicle: distilled water
- Concentration in vehicle: not applicable
- Total volume applied: 0.5 g
- Postexposure period: 5 days
- Removal of test substance: yes (washed away with water)
IN VITRO TEST SYSTEM: Not relevant
EXAMINATIONS
- Scoring system: skin irritation index according to OECD
404
- Examination time points: 1, 24, 48, 72 hours and 5 days
SOURCE: EKA Kemi AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Sodium Metasilicate (pentahydrate).
Applied as moistened substance (concentration not indicated).
(2) valid with restrictions
Guideline study, but no information on purity of test
substance.
Critical study for SIDS endpoint
(7)
Species:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
Semiocclusive
4 hour(s)
1
water
8
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
213
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
- Controls: no
ADMINISTRATION/EXPOSURE
- Preparation of test substance: moistened before
application with distilled water
- Area of exposure: intact skin (shaved)
- Occlusion: semiocclusive
- Vehicle: distilled water
- Concentration in vehicle: not applicable
- Total volume applied: 0.5 g
- Postexposure period: 5 days
- Removal of test substance: yes (washed away with water)
IN VITRO TEST SYSTEM: Not relevant
EXAMINATIONS
- Scoring system: skin irritation index according to OECD
404
- Examination time points: 1, 24, 48, 72 hours and 5 days
SOURCE: EKA Kemi AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Sodium Metasilicate (nonahydrate).
Applied as moistened substance (concentration not indicated).
(2) valid with restrictions
Guideline study, but no information on purity of test
substance.
Critical study for SIDS endpoint
(7)
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
97 other:wt%
Semiocclusive
4 hour(s)
3
5,1
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
214
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
rabbit
57,5 other:wt%
Semiocclusive
4 hour(s)
3
7,8
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
215
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
Method:
Year:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
Result:
216
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
01-AUG-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
10 %
Semiocclusive
4 hour(s)
3
water
1,22
slightly irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
(10)
UNEP PUBLICATIONS
217
OECD SIDS
5. TOXICITY
Flag:
05-FEB-2003
Species:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
Semiocclusive
4 hour(s)
3
water
4,67
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
Result:
218
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
21-JAN-2004
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
6 other:wt%
Occlusive
24 hour(s)
8
corrosive
Method:
Test condition:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
219
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
05-FEB-2003
(48)
Species:
Concentration:
Exposure:
Exposure Time:
Result:
rabbit
99 other:wt%
Occlusive
4 hour(s)
not irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
220
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
05-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
37 other:wt%
Semiocclusive
4 hour(s)
5
water
7,4
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Reliability:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
221
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
Semiocclusive
4 hour(s)
6
water
8
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Reliability:
Result:
Test condition:
Test substance:
222
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Reliability:
06-FEB-2003
(36)
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
undiluted
Semiocclusive
4 hour(s)
3
other: none
,17
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
UNEP PUBLICATIONS
223
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
guinea pig
37 other:wt%
Semiocclusive
4 hour(s)
6
water
,3
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
224
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Exposure:
Exposure Time:
No. of Animals:
PDII:
Result:
guinea pig
Semiocclusive
4 hour(s)
6
2,4
moderately irritating
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
225
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
06-FEB-2003
(36)
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
PDII:
EC classificat.:
human
37 other:wt%
Semiocclusive
4
8
3,6
irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
226
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
06-FEB-2003
Species:
Exposure:
Exposure Time:
Result:
rat
Open
1 hour(s)
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Result:
Test condition:
UNEP PUBLICATIONS
227
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
01-AUG-2003
rabbit
10 other: wt%
irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
228
OECD SIDS
5. TOXICITY
Reliability:
05-FEB-2003
(48)
Species:
Concentration:
Dose:
Exposure Time:
Vehicle:
Result:
rabbit
undiluted
50 other: mg
,17 minute(s)
no data
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
UNEP PUBLICATIONS
229
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
Species:
Concentration:
Result:
rabbit
6 other: wt%
irritating
Method:
Test substance:
Reliability:
GLP:
Test substance:
Method:
Result:
230
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
05-FEB-2003
(48)
Species:
Concentration:
Result:
rabbit
5 other: wt%
irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
05-FEB-2003
(48)
Species:
Concentration:
Result:
rabbit
3 other: wt%
irritating
Method:
GLP:
Test substance:
Method:
Result:
231
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
05-FEB-2003
(48)
Species:
Concentration:
Dose:
Exposure Time:
Vehicle:
Result:
rabbit
undiluted
50 other: mg
,17 minute(s)
no data
corrosive
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
232
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
26-JAN-2004
Species:
rabbit
Method:
GLP:
Test substance:
Method:
Test substance:
Reliability:
Remark:
UNEP PUBLICATIONS
233
OECD SIDS
5. TOXICITY
Result:
Test condition:
Test substance:
Reliability:
05-FEB-2003
(48)
5.3 Sensitization
Type:
Species:
Concentration 1st:
2nd:
Vehicle:
Result:
Method:
Year:
GLP:
Test substance:
other: MEST
2002
no data
other TS
Method:
METHOD FOLLOWED:
DEVIATIONS FROM GUIDELINE: no Guideline method
GLP: not reported
STATISTICAL METHODS: Bartlett's chi-square Test, one-way ANOVA
and Dunnett's Multiple Range t Test.
METHOD OF CALCULATION: not reported
ANALYTICAL METHODS: not reported
RESULTS OF PILOT STUDY: minimal irritating concentration: 6%;
maximal non-irritating concentration: 4%
RESULTS OF TEST
- Sensitization reaction: 15% increase in ear swelling 48 h
after challenge for mice that were sensitized with 4%
metasilicate. 28% increase with positive control. According to
the authors sodium metasilicate is a weak sensitizer in this
test system.
- Clinical signs: not reported
- Rechallenge: not performed
TEST ANIMALS:
- Strain: BALB/c
- Sex: female
- Source: National Cancer Institute, USA
- Age: 45 - 60 days
Result:
Test condition:
234
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
10-JUL-2003
Type:
Species:
Concentration 1st:
2nd:
3rd:
Vehicle:
Result:
Method:
Year:
GLP:
Test substance:
Method:
METHOD FOLLOWED:
DEVIATIONS FROM GUIDELINE: 1-fluoro-2,4-dinitrobenzene (DNFB)
as positive control; test substance applied to both sides of
each ear.
GLP: not reported
STATISTICAL METHODS: Bartlett's chi-square Test, one-way ANOVA
and Dunnett's Multiple Range t Test.
METHOD OF CALCULATION: not reported
ANALYTICAL METHODS: not reported
RESULTS OF PILOT STUDY: minimal irritating concentration: 6%;
maximal non-irritating concentration: 4%
RESULTS OF TEST
- Sensitization reaction: sensitization with 2-6% did not
significantly alter cell proliferation in the auricular lymph
nodes, even though an increase of 30% and 40% at the 4% and 6%
treatment levels was measured, respectively. A greater than
30-fold increase was measured in the positive control.
- Clinical signs: not reported
Result:
UNEP PUBLICATIONS
235
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
21-NOV-2003
Sub-chronic
rat
Sprague-Dawley
oral feed
8 weeks
daily
0, 500 ppm Si
yes
Sex: male
Method:
Year:
GLP:
Test substance:
other
1999
no
other TS
Method:
Result:
236
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
22-MAY-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Doses:
Sub-acute
rat
Sex: male
Fischer 344
oral feed
26 days
daily
10 and 50 mg of silicon/100g diet and lower, not
UNEP PUBLICATIONS
237
OECD SIDS
5. TOXICITY
Control Group:
Method:
Year:
GLP:
Test substance:
other
1972
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
238
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
22-MAY-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Doses:
Control Group:
NOAEL:
Sub-chronic
rat
Wistar
drinking water
3 months
daily
200, 600 and 1800 ppm
yes
> 227 - 237 mg/kg bw
Sex: male/female
Method:
Year:
GLP:
Test substance:
other
1975
no
other TS
Method:
Result:
Test condition:
UNEP PUBLICATIONS
239
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
Flag:
25-NOV-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
Sub-chronic
rat
Sex: male/female
other: Wistar-DLC
drinking water
3 months
continously
no
23, 47, 110 mg/d (males), 21, 37, 84 mg/d (females)
yes
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
240
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
Test condition:
241
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
22-MAY-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
242
Chronic
rat
other: Wistar-SLC
drinking water
14 months
continously
no
167, 500, 1500 ppm
UNEP PUBLICATIONS
Sex: male/female
OECD SIDS
5. TOXICITY
Control Group:
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
UNEP PUBLICATIONS
243
OECD SIDS
5. TOXICITY
Test condition:
244
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
26-JAN-2004
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
NOAEL:
LOAEL:
Sub-acute
rat
Sex: male/female
other: Wistar-SLC
gavage
14 days
daily
no
Females: 62.5, 125, 250, 500 or 1000 mg/kg bw/d. Males:
37.5, 75, 150, 300, 600 mg/kg bw/d.
yes
= 125 mg/kg bw
= 250 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
UNEP PUBLICATIONS
245
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
246
OECD SIDS
5. TOXICITY
Reliability:
07-MAY-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
NOAEL:
LOAEL:
Sub-chronic
mouse
Sex: male/female
other: ddy
drinking water
3 months
continously
no
300, 900, 2700 ppm (males), 333, 1000, 3000 ppm
(females)
yes
= 260 - 284 mg/kg bw
= 716 - 892 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
females:
nominal dose
333
1000
3000 ppm
actual intake 2.2-2.6
6.5-7.1
17.9-22.3 mg/animal/d
actual dose
88-104
260-284
716-892 mg/kg bw/d
(calculations are based on an average body weight for mice of
25 g)
- Time of death: no mortality
- Number of deaths at each dose: no mortality
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: no mortality
- Clinical signs: no treatment-related effects
- Body weight gain: no treatment-related effects
- Food/water consumption: there were no effects on food and
water consumption.
- Ophthalmoscopic examination: not reported
- Clinical chemistry: no effects
- Haematology: There was an increase of the haematocrit level
UNEP PUBLICATIONS
247
OECD SIDS
5. TOXICITY
Test condition:
248
0.13
0.14
0.14
0.14
0.13
0.13
0.13
0.12
Ovaries
right
left
8.4
7.3
7.7
7.4
9.7
9.1
8.3
8.4
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
Flag:
28-NOV-2003
Type:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
NOAEL:
LOAEL:
Sub-acute
mouse
other: ddy
gavage
14 days
daily
no
37.5, 75, 150, 300, 600 mg/kg
yes
= 75 mg/kg bw
= 150 mg/kg bw
Sex: male/female
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
UNEP PUBLICATIONS
249
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
250
OECD SIDS
5. TOXICITY
the 14 days mouse study, and therefore the data are tainted
with uncertaintanties.
07-MAY-2003
(45)
Type:
Sub-acute
Species:
other: turkey
Sex: male
Strain:
other: Nicholas
Route of administration: oral feed
Exposure period:
4 weeks
Frequency of treatment: daily
Doses:
0, 270 ppm Si
Control Group:
yes
Method:
Year:
GLP:
Test substance:
other
1999
no
other TS
Method:
Result:
Test condition:
UNEP PUBLICATIONS
251
OECD SIDS
5. TOXICITY
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
15-JUL-2003
252
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Type:
System of testing:
Concentration:
Cytotoxic Concentration:
Metabolic activation:
Result:
Ames test
Salmonella typhimurium TA98, TA100, TA1535, TA1537
0.1, 1 and 10 mg/plate
not reported
with and without
negative
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
Test condition:
Test substance:
Reliability:
10-FEB-2003
UNEP PUBLICATIONS
253
OECD SIDS
5. TOXICITY
Cytogenetic assay
mouse
other: BDF1
oral feed
24 hours
negative
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
Test condition:
254
UNEP PUBLICATIONS
Sex: male
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
Flag:
01-OCT-2004
(18) (45)
5.7 Carcinogenicity
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Post exposure period:
Doses:
Control Group:
rat
other: Wistar-SLC
drinking water
14 months
continuous
no
167, 500, 1500 ppm
yes
Sex: male/female
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
UNEP PUBLICATIONS
255
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5. TOXICITY
Test condition:
256
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
22-JAN-2004
mouse
Sex: male/female
other: JLC-TCR
gavage
17-18 days
daily
18 days
12.5, 50 or 200 mg/kg bw/d, 10 ml/kg
yes
UNEP PUBLICATIONS
257
OECD SIDS
5. TOXICITY
Method:
Year:
GLP:
Test substance:
other
1980
no
other TS
Method:
Result:
258
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OECD SIDS
5. TOXICITY
259
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
01-AUG-2003
OECD SIDS
5. TOXICITY
Remark:
Reliability:
Flag:
28-NOV-2003
Type:
In Vitro/in vivo:
Species:
Strain:
Route of administration:
Exposure period:
Frequency of treatment:
Duration of test:
Doses:
Control Group:
Result:
Remark:
Reliability:
Flag:
28-NOV-2003
Remark:
Test substance:
Reliability:
Flag:
21-NOV-2003
UNEP PUBLICATIONS
261
OECD SIDS
5. TOXICITY
05-FEB-2003
262
(39)
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
263
OECD SIDS
6. REFERENCES
264
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
265
OECD SIDS
6. REFERENCES
266
UNEP PUBLICATIONS
OECD SIDS
Existing Chemical
CAS No.
Substance name
Synonym
Molecular Formula
ID: 10213-79-3
10213-79-3
disodium metasilicate pentahydrate
Silicic acid (H2SiO3), disodium salt, pentahydrate
H2O3Si.5H2O.2Na
Printing date:
Revision date:
Date of last Update:
22-NOV-2004
Number of Pages:
23-JAN-2004
Chapter (profile):
Chapter: 1.0.1, 1.1.1
Reliability (profile): Reliability: without reliability, 1, 2, 3, 4
Flags (profile):
Flags: without flag, confidential, non confidential, WGK
(DE), TA-Luft (DE), Material Safety Dataset, Risk
Assessment, Directive 67/548/EEC, SIDS
UNEP PUBLICATIONS
267
OECD SIDS
1. GENERAL INFORMATION
lead organisation
Centre Europeen d'Etude des Silicates (CEES)
Jol Wilmot
Remark:
23-JAN-2004
1.1.1 General Substance Information
Purity type:
Substance type:
Physical status:
Purity:
Colour:
Remark:
23-JAN-2004
268
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OECD SIDS
Existing Chemical
CAS No.
Substance name
Synonym
Molecular Formula
ID: 13517-24-3
13517-24-3
Sodium metasilicate nonahydrate
Silicic acid (H2SiO3), disodium salt, nonahydrate
H2O3Si.9H2O.2Na
Printing date:
Revision date:
Date of last Update:
23-NOV-2004
Number of Pages:
23-JAN-2004
Chapter (profile):
Chapter: 1.0.1, 1.1.1
Reliability (profile): Reliability: without reliability, 1, 2, 3, 4
Flags (profile):
Flags: without flag, confidential, non confidential, WGK
(DE), TA-Luft (DE), Material Safety Dataset, Risk
Assessment, Directive 67/548/EEC, SIDS
UNEP PUBLICATIONS
269
OECD SIDS
1. GENERAL INFORMATION
lead organisation
Centre Europeen d'Etude des Silicates (CEES)
Jol Wilmot
Date: 23-JAN-2004
Av. E van Nieuwenhuyse, 4
B-1160 Bruxelles
Belgium
+32 26767288
+32 26767347
Remark:
23-JAN-2004
http://www.cees-silicates.org
Remark:
23-JAN-2004
270
UNEP PUBLICATIONS
OECD SIDS
Existing Chemical
CAS No.
EINECS Name
EC No.
TSCA Name
ID: 1312-76-1
1312-76-1
Silicic acid, potassium salt
215-199-1
Silicic acid, potassium salt
Printing date:
Revision date:
Date of last Update:
22-NOV-2004
Number of Pages:
49
21-OCT-2004
Chapter (profile):
Chapter: 1, 2, 3, 4, 5
Reliability (profile): Reliability: without reliability, 1, 2, 3, 4
Flags (profile):
Flags: without flag, confidential, non confidential, WGK
(DE), TA-Luft (DE), Material Safety Dataset, Risk
Assessment, Directive 67/548/EEC, SIDS
UNEP PUBLICATIONS
271
OECD SIDS
1. GENERAL INFORMATION
lead organisation
Centre Europeen d'Etude des Silicates (CEES)
Jol Wilmot
Date: 28-FEB-2003
Av. E van Nieuwenhuyse, 4
B-1160 Bruxelles
Belgium
+32 26767288
+32 26767347
Remark:
21-NOV-2003
http://www.cees-silicates.org
Remark:
272
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
Remark:
1.1.2 Spectra
1.2 Synonyms and Tradenames
Potassium polysilicate
09-JAN-2002
Potassium silicate
UNEP PUBLICATIONS
273
OECD SIDS
1. GENERAL INFORMATION
21-MAR-1994
Potassium waterglass
21-MAR-1994
Silicic acid, potassium salt
07-OCT-1994
Soluble potash glass
21-MAR-1994
Soluble potash waterglass
12-NOV-2002
1.3 Impurities
Purity type:
Remark:
Impurities stem from the quartz sand used rather than from
potash. Therefore, impurities of potassium silicates are
similar to sodium silicates of comparable molar ratios. The
following impurities were reported for sodium silicate lumps
of weight ratio 3.35 (molar ratio 3.46):
Reliability:
Flag:
03-DEC-2003
Na2SO4: 0.06%
NaCl: 0.06%
Fe2O3: 0.033%
Al2O3: 0.097%
CaO: 0.03%
MgO: 0.02%
TiO2: 0.019%
(4) not assignable
Review article only
Critical study for SIDS endpoint
(9)
Purity type:
Remark:
Result:
Li
K
Mg
Ca
Sr
Ba
Al
P
S
Ti
274
0.2-0.5
20-50
5-20
1-80
1-5
<1-5
50-200
<1-10
10-30
30-80
UNEP PUBLICATIONS
OECD SIDS
1. GENERAL INFORMATION
Reliability:
Flag:
03-DEC-2003
V
0.1-0.8
Cr
<1
Mn
<0.5-1
Fe
25-100
Co
<1
Ni
<0.5
Cu
<0.1-0.2
Zn
<0.2-1
La
0.2-1
Ce
<0.3-2
Zr
5-20
W
<1-25
all contents in ppm
(4) not assignable
Handbook data
Critical study for SIDS endpoint
(10)
1.4 Additives
1.5 Total Quantity
Quantity:
Remark:
Reliability:
Quantity
(4) not
Handbook
Critical
Flag:
04-DEC-2003
1.6.1 Labelling
Labelling:
provisionally by manufacturer/importer
Remark:
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275
OECD SIDS
1. GENERAL INFORMATION
type
Non dispersive use
04-FEB-2003
Type:
Category:
type
Use resulting in inclusion into or onto matrix
04-FEB-2003
Type:
Category:
type
Wide dispersive use
04-FEB-2003
Type:
Category:
industrial
Paints, lacquers and varnishes industry
04-FEB-2003
Type:
Category:
industrial
Personal and domestic use
21-JAN-2004
Type:
Category:
industrial
Photographic industry
15-DEC-2003
Type:
Category:
industrial
Public domain
15-DEC-2003
276
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OECD SIDS
1. GENERAL INFORMATION
Type:
Category:
use
Adhesive, binding agents
15-DEC-2003
Type:
Category:
(37)
use
Cleaning/washing agents and disinfectants
15-DEC-2003
Type:
Category:
use
Construction materials additives
Remark:
15-DEC-2003
Type:
Category:
use
Fertilizers
15-DEC-2003
Type:
Category:
(38)
use
Impregnation agents
15-DEC-2003
Type:
Category:
(6) (38)
use
Non agricultural pesticides
15-DEC-2003
Type:
Category:
(6) (38)
use
Photochemicals
15-DEC-2003
Type:
Category:
use
Welding and soldering agents
Remark:
15-DEC-2003
Type:
Category:
use
other: car-care product
15-DEC-2003
Type:
Category:
(38)
use
other: cleaning agent in food and beverage industry
15-DEC-2003
Type:
Category:
(6)
use
other: paint additive
15-DEC-2003
UNEP PUBLICATIONS
277
OECD SIDS
1. GENERAL INFORMATION
16-DEC-2003
KBwS (DE)
1 (weakly water polluting)
Reliability:
08-JAN-2004
(22)
21-OCT-2004
Source of exposure: Human: exposure through intended use
278
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OECD SIDS
1. GENERAL INFORMATION
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Human: exposure of the consumer/bystander
Exposure to the:
Substance
Remark:
21-OCT-2004
21-OCT-2004
Source of exposure: Environment: exposure from formulation
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Environment: exposure from processing
Exposure to the:
Substance
Remark:
21-OCT-2004
Source of exposure: Environment: exposure through private use
Exposure to the:
Substance
Remark:
21-OCT-2004
1.11 Additional Remarks
1.12 Last Literature Search
1.13 Reviews
UNEP PUBLICATIONS
279
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Remark:
Reliability:
16-DEC-2003
(9)
Value:
Decomposition:
905 degree C
no at degree C
Remark:
Test substance:
Reliability:
Flag:
20-OCT-2004
30-SEP-2004
2.3 Density
Type:
Value:
density
ca. 1.25 - 1.42 g/cm at 20 degree C
Remark:
Flag:
20-OCT-2004
Type:
density
Test substance:
Reliability:
280
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Value:
Test substance:
Flag:
20-OCT-2004
Type:
Value:
density
1.26 - 1.6 g/cm at 20 degree C
Test substance:
Flag:
20-OCT-2004
Type:
Value:
bulk density
ca. 750 kg/m3 at 20 degree C
Test substance:
Reliability:
Reliability:
Reliability:
Flag:
20-OCT-2004
2.3.1 Granulometry
2.4 Vapour Pressure
Remark:
Reliability:
08-JAN-2004
281
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Reliability:
Flag:
20-OCT-2004
Remark:
Reliability:
Flag:
20-OCT-2004
Water
Remark:
Flag:
19-OCT-2004
Solubility in:
Water
Remark:
21-OCT-2004
Solubility in:
Value:
Water
115 mg/l at 25 degree C
Remark:
Flag:
03-DEC-2003
Solubility in:
other: alcohol
Remark:
Reliability:
Insoluble in alcohol.
(2) valid with restrictions
Peer-reviewed handbook data.
Reliability:
Reliability:
Reliability:
282
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Flag:
17-DEC-2003
pH
11 - 13
value:
Remark:
Reliability:
Flag:
21-OCT-2004
Remark:
Reliability:
Flag:
21-OCT-2004
Remark:
Reliability:
(1)
21-OCT-2004
Remark:
Reliability:
21-OCT-2004
(27)
UNEP PUBLICATIONS
283
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Remark:
Reliability:
21-OCT-2004
2.9 Flammability
Result:
non flammable
Remark:
Reliability:
21-OCT-2004
not explosive
Remark:
Reliability:
21-OCT-2004
no oxidizing properties
Remark:
Reliability:
21-OCT-2004
Remark:
284
UNEP PUBLICATIONS
OECD SIDS
2. PHYSICO-CHEMICAL DATA
Reliability:
34.4
39.5
40.5
41.1
(4) not assignable
Collection of data
3.46
3.28
3.14
2.87
45
950 (at 25C)
280
45
19-DEC-2003
(12)
Value:
Remark:
Reliability:
Total solids
Molar ratio
Viscosity
wt %
SiO2/K2O
mPa.s at 20C
------------------------------------------------29.9
3.89
180
34.8
3.21
30
52.4
2.24
200
(4) not assignable
Handbook data
21-OCT-2004
(27)
UNEP PUBLICATIONS
285
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
3.1.1 Photodegradation
Remark:
Reliability:
26-JAN-2004
Reliability:
18-DEC-2003
Remark:
Reliability:
18-DEC-2003
Polymerisation-Depolymerisation:
Upon dilution of concentrated commercial silicate solutions
with water, the highly cross-linked polysilicate ions
depolymerize rapidly to monosilicate ions, the extent of
depolymerisation depending on the dilution factor.
(2) valid with restrictions
Acceptable procedure and publication
(29)
The basic consideration is that silica dissolves according
to : SiO2 + H2O = Si(OH)4. At low concentrations most species
are present as monomers, at higher concentrations
polymerisation will occur.
Most soluble silicates are in the form:
M2O . mSiO2 . nH2O
where M = alkali metal, predominantly Na, but also K. The
index m (molar ratio) ranges between 0.5 - 4, most commonly
m = 3.3. Stability depends to a large extent on pH, above pH
10.6 the solutions are chemically stable. The increase of
ionic strength accelerates nucleation and deposition and
decreases the SiO2 solubility. Coating of surfaces by
organic matter may hamper dissolution, but at the same time
Si(OH)4 may form complexes with organic matter, a process
which favours dissolution.
(4) not assignable
Handbook data
(10)
286
UNEP PUBLICATIONS
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Remark:
Reliability:
Flag:
18-DEC-2003
Reliability:
Flag:
18-DEC-2003
287
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
Remark:
Reliability:
Flag:
18-DEC-2003
SiO2 enters surface waters via the four main application areas
where emissions to water systems might occur (household
detergents, pulp-and paper production, water treatment, and
soil stabilisation).
Seen in the context of the natural silica cycle, and natural
loading of water systems with silicates due to weathering of
soil and rocks, weathering of sediments and atmospheric
deposition, this amount is small.
(2) valid with restrictions
Well-documented scientific publication.
Critical study for SIDS endpoint
(34) (39)
Reliability:
19-DEC-2003
3.3.2 Distribution
Remark:
18-DEC-2003
Remark:
Reliability:
18-DEC-2003
OECD SIDS
3. ENVIRONMENTAL FATE AND PATHWAYS
18-DEC-2003
3.7 Bioaccumulation
Remark:
Reliability:
08-JAN-2004
UNEP PUBLICATIONS
289
OECD SIDS
4. ECOTOXICITY
AQUATIC ORGANISMS
4.1 Acute/Prolonged Toxicity to Fish
Type:
Species:
Exposure period:
Unit:
LC0:
LC50:
LC100:
static
Leuciscus idus
48 hour(s)
mg/l
= 146
> 146
> 146
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
290
OECD SIDS
4. ECOTOXICITY
Test substance:
Reliability:
Flag:
05-FEB-2003
static
Daphnia magna
24 hour(s)
mg/l
= 146
> 146
> 146
Method:
Year:
GLP:
Test substance:
Method:
Result:
(Crustacea)
Analytical monitoring: no data
UNEP PUBLICATIONS
291
OECD SIDS
4. ECOTOXICITY
Test condition:
TEST ORGANISMS
- Strain: Daphnia magna Straus, own breed, strain identical
with the strain of the Bundesgesundheitsamt/Inst.
Wasser-Boden-Luft
- Supplier: Henkel KGaA
- Wild caught: no
- Feeding: algae (Chlorella kessleri)
- Feeding during test: no
STOCK AND TEST SOLUTION AND THEIR PREPARATION:
Stock solution of 10 g test substance/l test medium.
Aliquots of 5 ml were pipetted into 95 ml test medium and
distributed into test vessels.
DILUTION WATER
- Hardness: about 14dH (80 mg Ca and 12.2 mg Mg per litre)
- Salinity: test medium
294 mg/l CaCl2 x 2H2O
123 mg/l MgSO4 x 7H2O
63 mg/l NaHCO3
5.5 mg/l KCl
TEST SYSTEM
- Test type: Daphnia magna acute toxicity
- Concentrations: 500 mg product/l (nominal)
- Renewal of test solution: no, static test
- Exposure vessel type: glass beakers, covered with glass
plates
- Number of replicates, animals per replicate: approximately
20 animals per concentration, no replicates
- Test temperature: about 22 C
- Dissolved oxygen: not reported
- pH: not reported
- Adjustment of pH: not reported
- Intensity of irradiation: not reported
- Photoperiod: about 16 hours photoperiod/day
DURATION OF THE TEST: 24 hours
TEST PARAMETER: Immobilisation
MONITORING OF TEST SUBSTANCE CONCENTRATION: no
SOURCE: Henkel KGaA
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: not reported
ANY OTHER INFORMATION: 29.1% potassium silicate, soluble and
not volatile at room temperature, molar ratio SiO2/K2O:
3.9-4.1
(2) valid with restrictions
Guideline study, but the report details are limited.
Critical study for SIDS endpoint
(31)
Test substance:
Reliability:
Flag:
05-FEB-2003
292
UNEP PUBLICATIONS
OECD SIDS
4. ECOTOXICITY
UNEP PUBLICATIONS
293
OECD SIDS
5. TOXICITY
LD50
rat
other: Cpb:Wu, Wistar Random
male/female
no data
2.50, 3.00, 3.60, 4.32, 5.20 ml/kg bw
= 5700 mg/kg bw
Method:
Year:
GLP:
Test substance:
other
1981
no
other TS
Method:
Result:
Test condition:
Test substance:
294
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Reliability:
Flag:
05-FEB-2003
rabbit
29 other: wt%
Occlusive
24 hour(s)
0
not irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
295
OECD SIDS
5. TOXICITY
12-JAN-2004
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
Result:
rabbit
39 other: wt%
Occlusive
24 hour(s)
2
slightly irritating
Method:
GLP:
Test substance:
Method:
04-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
PDII:
rabbit
85 other: wt%
Occlusive
24 hour(s)
8
Reliability:
Result:
Test condition:
Test substance:
Reliability:
296
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Result:
highly irritating
Method:
GLP:
Test substance:
Method:
04-FEB-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
8.8 other:wt%
Occlusive
4 hour(s)
3
other: deionised water
0
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
UNEP PUBLICATIONS
297
OECD SIDS
5. TOXICITY
Result:
Flag:
25-NOV-2003
AVERAGE SCORE:
- Erythema: 0
- Edema: 0
REVERSIBILITY: 48 hours after treatment the effects were no
longer present.
OTHER EFFECTS: Very slight erythema was observed 24 and 48
hours after treatment. None of these effects were observed
thereafter. This is reported in the summary but not in the
table of effects.
TEST ANIMALS:
- Strain: New Zealand White
- Sex: not reported
- Source: not reported
- Age: not reported
- Weight at study initiation: 3.0 kg (average)
- Number of animals: 3
- Controls: yes (unexposed skin area on same animal)
ADMINSTRATION/EXPOSURE:
- Preparation of test substance: dilution in deionised water
- Area of exposure: Intact skin (shaved)
- Occlusion: yes
- Vehicle: deionised water
- Concentration in vehicle: 8.75%
- Total volume applied: 0.5 ml
- Post-exposure period: 7 days
- Removal of test substance: yes
IN VITRO TEST SYSTEM: not relevant
EXAMINATIONS:
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 7 days
SOURCE: Woellner-Werke GmbH
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 25% dilution of 35 wt% potassium
waterglass. Molar ratio 3.4.
(2) valid with restrictions
Guideline study, but no information on purity of test
substance.
Critical study for SIDS endpoint
(19)
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
7 other:wt%
Occlusive
4 hour(s)
5
other: deionised water
0
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
298
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
35 other:wt%
Occlusive
4 hour(s)
3
other: deionised water
.17
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
299
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
33 other:wt%
Semiocclusive
4 hour(s)
1
water
3
moderately irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
300
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Flag:
04-AUG-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
29 other:wt%
Occlusive
4 hour(s)
5
other: deionised water
.25
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Test condition:
Test substance:
Reliability:
Result:
UNEP PUBLICATIONS
301
OECD SIDS
5. TOXICITY
Test condition:
Test substance:
Reliability:
Flag:
25-NOV-2003
Species:
Concentration:
Exposure:
Exposure Time:
No. of Animals:
Vehicle:
PDII:
Result:
rabbit
36 other:wt%
Semiocclusive
4 hour(s)
1
water
1
slightly irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
302
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Test substance:
Reliability:
Flag:
25-NOV-2003
rabbit
80 other: wt%
highly irritating
Method:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
UNEP PUBLICATIONS
303
OECD SIDS
5. TOXICITY
Reliability:
12-JAN-2004
(34)
Species:
Concentration:
Dose:
Comment:
No. of Animals:
Vehicle:
Result:
rabbit
7 other:wt%
.1 ml
not rinsed
6
other: deionised water
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Flag:
304
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
25-NOV-2003
(14)
Species:
Concentration:
Dose:
Comment:
No. of Animals:
Vehicle:
Result:
rabbit
29 other:wt%
.1 ml
not rinsed
6
water
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Flag:
25-NOV-2003
Species:
UNEP PUBLICATIONS
305
OECD SIDS
5. TOXICITY
Concentration:
Dose:
Comment:
No. of Animals:
Vehicle:
Result:
35 other:wt%
.1 ml
not rinsed
3
water
slightly irritating
Method:
Year:
GLP:
Test substance:
Method:
Flag:
25-NOV-2003
Species:
Concentration:
Dose:
rabbit
8.8 other:wt%
.1 ml
Result:
Test condition:
Test substance:
Reliability:
306
UNEP PUBLICATIONS
OECD SIDS
5. TOXICITY
Comment:
No. of Animals:
Vehicle:
Result:
not rinsed
3
water
not irritating
Method:
Year:
GLP:
Test substance:
Method:
Result:
Test condition:
Test substance:
Reliability:
Flag:
25-NOV-2003
5.3 Sensitization
UNEP PUBLICATIONS
307
OECD SIDS
5. TOXICITY
Remark:
Reliability:
Flag:
25-NOV-2003
Type of experience:
Remark:
Reliability:
25-NOV-2003
308
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
309
OECD SIDS
6. REFERENCES
UNEP PUBLICATIONS
OECD SIDS
6. REFERENCES
UNEP PUBLICATIONS
311