K822585 SDS00082258563 EN R2 459894 Chromogenix Coamatic Fviii Msds

SAFETY DATA SHEET Doc.
ID: SDS00082258563_EN
COAMATIC FACTOR VIII Revision: 02
CO: 459894
Edited on: 10/20/2015
IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY
Identification of the product

Product Name: COAMATIC FACTOR VIII
Product Number: 0082258563
Use of the product: For in vitro diagnostic use
Company identification: MANUFACTURER: DISTRIBUTOR EU:
Instrumentation Laboratory Co. Via Leonardo da Vinci, 36
180 Hartwell Road, 20877 Roncello (MB), Italy
Bedford, MA 01730-2443 (USA)
Tel. +1 800 678 0710 DISTRIBUTOR US/CANADA:
Fax +1 781 863 9928 Instrumentation Laboratory Co.
526 Route 303
Orangeburg, New York 10962 (USA)
E-mail address of the competent person: [email protected]
Emergency phone: +44 (0) 3700 492 795
+1 215 207 0061 (USA and Canada)
INFORMATION ON COMPOSITION/HAZARD OF THE PRODUCT
Mixture classification
According to Mixture classification
Kit
P/N Mixture name Hazard Communication Standard, According to
configuration
29 CFR 1910.1200 (HCS) 1272/2008/EC Regulation
Hazardous Product Regulation HPR (WHMIS 2015)
000H00510 FACTOR REAGENT Respiratory or skin sensitization, cat.1 Resp. Sens. 1, H334 2 x 3 mL
000H00455 S-2765+I-2581 Not classified Not classified 1 x 6 mL
BUFFER, STOCK
000H00603 Not classified Not classified 1 x 24 mL
SOLUTION
Disclaimer
This document is intended only as a guide to appropriate precautionary handling of this product by a trained person, or supervised by a person
trained in chemical handling. The product shall not be used for purposes different from those indicated in section 1, unless having received
suitable written instructions on how to handle the material. Use the product in accordance with the Good Laboratory Practice. This document
cannot describe all potential dangers of use or interaction with other chemicals or materials. It is the user’s responsibility for the product’s safe
use, the product’s suitability for the intended use and the product’s safe disposal. No representation or warranties, either expressed or implied,
of merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to the information set forth herein
or to the product to which the information refers. The contained information in this SDS are in accordance with Annex II of the Regulation (EC)
No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals
(REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012) as
recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR (WHMIS 2015) as recommended by Health Canada
(HC).
Prepared by: Chemsafe Srl
Page 1 of 26
SAFETY DATA SHEET Doc. ID: SDS00082258563_EN
FACTOR REAGENT Revision: 02
CO: 459894
Edited on: 10/20/2015
SECTION 1. IDENTIFICATION OF THE MIXTURE AND OF THE COMPANY
1.1 Identification of the mixture

Product Name: FACTOR REAGENT
Product Number: 000H00510
1.2 Use of the mixture:
Relevant use: For in vitro diagnostic use.
Uses advised against: There are no specific uses advised against.
1.3 Company identification: MANUFACTURER: DISTRIBUTOR EU:
526 Route 303
1.4 Emergency phone: +44 (0) 3700 492 795
+1 215 207 0061 (USA and Canada)
SECTION 2. HAZARDS IDENTIFICATION
2.1 Classification of the mixture:

This product is hazardous according to Regulations (EC) No 1272/2008, OSHA 29 CFR 1910.1200 and Hazardous Product Regulation HPR
(WHMIS 2015).
Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet.
According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
according to Hazardous Product Regulation HPR (WHMIS 2015):
Hazard class Hazard category Hazard statement
May cause allergy or asthma symptoms or breathing
RESPIRATORY OR SKIN SENSITISATION cat. 1
difficulties if inhaled. (H334)
For exposure limits see ch. 8
Potential adverse physicochemical, human health and environmental effects (see also ch. 9-12)
The product may cause allergy or asthma symptoms or breathing difficulties if inhaled.
Under normal conditions of use, the mixture does not cause adverse effects to the environment.
2.2 Label elements, according to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR
1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015):
Hazard pictogram(s):
Signal word(s): Danger

Hazard statement(s): May cause allergy or asthma symptoms or breathing difficulties if inhaled. (H334)
Avoid breathing vapors/ spray. (P261)
[In case of inadequate ventilation] wear respiratory protection. (P284)
IF INHALED: Remove person to fresh air and keep comfortable for breathing. (P304 + P340)
Precautionary statement(s):
If experiencing respiratory symptoms: Call a POISON CENTER/doctor . (P342 + P311)
Dispose of contents/container in accordance with local/regional/national/international
regulation. (P501)
Contains Factor IXa, Factor X.
Other labeling details: Up to 60.7% of the mixture consists of component of unknown acute toxicity (oral, dermal,
inhalation) for the human health and for the aquatic environment.
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2.3 Other hazards (which do not results in the classification)

The mixture does not meet the criteria for PBT or vPvB.
Warning:
The product contains bovine material. All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem
health inspection by a veterinarian, and they were apparently free from infectious and contagious material. However, the material should
be treated as potentially infectious.
Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma symptoms or breathing difficulties if inhaled.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Composition: solid containing organic and inorganic components, bovine source material.
3.1 Hazardous components:
Classification
EINECS/ Conc. % Classification
Name CAS n° 29 CFR 1910.1200 (HCS)
ELINCS n° w/w* 1272/2008/EC
HPR (WHMIS 2015)
Factor X Not available Not available < 1.5 % Skin Corrosion/Irritation, cat. 2 Skin Irrit. 2, H315
Index N. (Annex VI of CLP Reg.): Eye damage/Eye Irritation, cat. 2A Eye Irrit. 2, H319
647-014-00-9 - proteases with Specific target organ Toxicity – STOT SE 3, H335
the exception of those specified Single Exposure, cat. 3 Resp. Sens. 1, H334
elsewhere in this Annex Sensitization-Respiratory, cat. 1
Factor IXa Not available Not available < 1.5 % Skin Corrosion/Irritation, cat. 2 Skin Irrit. 2, H315
Index N. (Annex VI of CLP Reg.): Eye damage/Eye Irritation, cat. 2A Eye Irrit. 2, H319
Calcium chloride dehydrate 233-140-8 10035-04-8 0.3-0.4% Eye damage/irritation, cat. 2 Eye Irrit.2, H319
Index N. (Annex VI of CLP Reg.): (as Calcium (10043-52-4
017-013-00-2 chloride as Calcium
anhydrous) chloride anhydr.)
Bovine thrombin 232-648-7 9002-04-4 0.0004- Skin Corrosion/Irritation, cat. 2 Skin Irrit. 2, H315
Index N. (Annex VI of CLP Reg.): 0.0005% Eye damage/Eye Irritation, cat. 2A Eye Irrit. 2, H319
For exposure limits see ch. 8, for hazard statements text see ch. 16.
* a range may be indicated, considering batch-to batch variation.
The mixture does not contain substances listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP,
OSHA:. See Section 11 and 15.
SECTION 4. FIRST AID MEASURES
4.1 Description of first aid measures

Ingestion: If swallowed rinse mouth with plenty of water provided person is conscious. Do not induce vomiting.
Get medical advice if adverse symptoms appear.
Inhalation exposure: If inhaled, move person to fresh air. If breathing is difficult, oxygen should be administered. Get
medical advice immediately (show the SDS or the label were possible).
Contact with skin: Remove contaminated clothes and shoes. Wash immediately affected area with soap or mild
detergent and plenty of water until the removal of the mixture (15-20 minutes). Get medical advice if
adverse symptoms appear.
Contact with eyes: Wash immediately with plenty of water or normal saline for at least 15 minutes. Keep eyelid open with
the finger. Get medical advice if adverse symptoms appear.
4.2 Most important symptoms and effects (acute and delayed)
Acute: Inhalation: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Skin : May be irritant for skin.
Eyes: May cause irritation.
Ingestion: may cause irritation to the gastrointestinal mucous membranes.
Delayed: Delayed symptoms and effects are not known.
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4.3 Indication of any immediate medical attention and special treatment needed
Medical monitoring: Based on the assessment of risk of hazardous chemical agents, the competent person will settle the
appropriate medical surveillance protocol, in accordance with the national legislation, in order to
protect the health status of the workers.
Antidotes, if known: Not known.
SECTION 5. FIRE-FIGHTING MEASURES
5.1 Extinguishing media

Suitable extinguishing media: Water spray or regular foam, CO2, dry powder.
Unsuitable extinguishing media: Not known.
5.2 Special hazards arising from the substance or mixture
Hazardous combustion products: Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, NOx, SOx,
HCl.
5.3 Advice for firefighters
Protective actions: Water jets can be used successfully to cool containers exposed to the fire and disperse fumes.
Equipment for self-protection: Self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves.
Equipment must be conformed with the national/international standards and used in highest condition
of protection on the basis of the information reported in the previous sub-sections.
SECTION 6. ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions, protective equipment and emergency procedures

For non-emergency Remove the ignition and heat sources, provide sufficient ventilation and evacuate the area.
personnel: Respiratory protection: is not required. Where risk assessment shows air-purifying respirators are
appropriate, use masks with approved filter. Suitable protective clothing, rubber or polythene gloves,
rubber shoes, safety glasses.
For emergency responders: Wear appropriate protective equipment (see Section 8) to minimize exposure to the product.
6.2 Environmental precautions Do not let the product enter drainage system, surface and ground-water or soil. Contact local
authorities in case of environmental release. Do not empty into drains.
6.3 Methods and material for Soak up with inert absorbent material, and clean with plenty of water. collect spilled material in
containment and cleaning up containers. Send to the storage waiting for disposal procedures.
6.4 Reference to other sections See also section 8 and 13.
SECTION 7. HANDLING AND STORAGE
7.1 Precautions for safe handling Handle in a well ventilated place, and away from sparkles and flames - sources of ignition. Keep the
mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear
suitable Personal Protection Equipment (see section 8).
Do not eat, drink and smoke in the working areas. Wash hands with soap and water after handling
the mixture. Remove contaminated clothing and protective equipment before entering eating areas.
7.2 Conditions for safe storage, Recommended temperature: store at 2-8°C. Avoid light exposure and keep away from heat sources.
incompatibilities Room ventilation: well ventilated workplace. Keep containers tightly closed and labelled with the name
of the product. Avoid environmental release.
Keep away from food and drinks.
7.3 Specific end use Factor Reagent is intended for in vitro diagnostic use. The material contains Factor X and Factor IXa,
may cause allergy or asthma symptoms or breathing difficulties if inhaled. It contains also Bovine
serum albumin (BSA), might cause allergic skin reaction and/or allergy or asthma symptoms or
breathing difficulties if inhaled. It should be treated as potentially infectious. Avoid inhalation of
dust/fume. Use the product in accordance with the Good Laboratory Practice.
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SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Control parameters

Community/National occupational exposure limit values:
(1)
Calcium chloride
Canada – Ontario: Occupational exposure limit (OEL) for calcium chloride of 5 mg/m3 has been established by the Ministry of Labor
Community/National biological exposure limit values: Not established.
DNEL values (components):
Workers Consumers
Component Route of exposure Acute effects Chronic effects Acute effects Chronic effects
local systemic local systemic local systemic local systemic
Calcium chloride Oral (mg/(mg/kg bw/day
anhydr. (2) Dermal (mg/kg bw/day)
Inhalation (mg/m3) 10 5 5 2.5
PNEC values (components): Not established.

The measurement of substances at the workplace must be carried out with standardized methods or, failing that, with appropriate
methods.
8.2 Exposure controls
8. 2. 1. Appropriate engineering controls
Appropriate risk management measures, that must be adopted at the workplace, have to be selected and applied, following the risks
assessment carried out by the employer, in connection with his working activity. If the results of this evaluation show that the general
and collective prevention measures are not sufficient to reduce the risk, and if you cannot prevent exposure to the mixture by other
means, adequate personal protective equipment must be adopted, complying with the relevant technical national/international standards.
8.2.2. Individual protection measures, such as Personal Protective Equipment (PPE)
Respiratory protection: Respiratory protection is not required. Where risk assessment shows air-purifying respirators are
appropriate, use masks with approved filter.
Use only devices approved by the Competent Authorities such as NIOSH (USA) and CEN (EU).
Skin protection: Protective clothing, rubber gloves.
Eye protection: Safety glasses.
Hand protection: Protective gloves.
Other protective systems: Personal protective equipment (PPE) useful for reducing individual exposure.
8.2.3.Environmental exposure controls
Avoid any release into the environment.
SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties

Value Related to
Appearance: solid
Odor: not available
Color: White to off white
pH: not available
Flammability: not available
Explosive properties: not available
Oxidizing properties: not available
Density: not available
Solubility: not available
Water Solubility: Soluble Mixture
Melting point/range: not available
9.2 Other information
Miscibility miscible
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SECTION 10. STABILITY AND REACTIVITY
10.1 Reactivity This mixture is considered not reactive under the normal conditions of the usage.
10.2 Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 –
8 °C.
10.3 Possibility of hazardous Not foreseen.
reactions
10.4 Conditions to avoid: Keep away from heat, water, humidity and light.
10.5 Incompatible materials Strong oxidising agents.
10.6 Hazardous decomposition Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, NOx, SOx,
products: HCl.
SECTION 11. TOXICOLOGICAL INFORMATION
The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided
bellow.
11.1 Information on toxicological effects
Symptoms and effects for each route of exposure:
Dermal: May cause skin irritation.
Ingestion: Ingestion may cause irritation to the gastrointestinal mucous membranes.
Inhalation: The product may cause allergy or asthma symptoms or breathing difficulties if inhaled.
Contact with eyes: May cause eye irritation.
Toxicokinetic effects (Absorption, Distribution, Metabolism, Excretion):
Calcium chloride : is easily dissociated into calcium and chloride ions in water. The absorption, the distribution and the excretion of the
(1)
ions in animals are regulated separately. Both ions are essential constituents of the body of all animals.
Acute toxicity Value m.u. Effects Related to
(1)
Oral: LD50 (rat) =3,798 - 4,179 mg/Kg The acute oral toxicity is attributed to Calcium chloride
LD50 (rabbit)=500 – 1,000 the severe irritating property of the
original substance or its high-
concentration solutions to the
gastrointestinal tract.
(1)
Dermal: LD50 (rabbit) > 5,000 mg/Kg Calcium chloride
Inhalation: LC50 (rat) > 40 mg/m3/4h (1)
Calcium chloride
Corrosion/Irritation
Skin Corrosion/Irritation Calcium chloride is not irritating for the skin. (1)
(1)
Serious eye damage/ irritation Calcium chloride is irritating for the eyes.
Sensitization:
Skin sensitization: Calcium chloride: Due to lack of data the classification is not possible.
Bovine serum albumin (BSA), which is present in bovine plasma, could develop allergic skin reactions in
laboratory workers after dealing with BSA powder. Based on the available data, the criteria for
classification are not satisfied.
Respiratory sensitization: The material contains Factor X and Factor IXa, may cause allergy or asthma symptoms or breathing
difficulties if inhaled.
Bovine serum albumin (BSA), which is present in bovine plasma, could develop allergic reactions in
laboratory workers after dealing with BSA powder. It is reported a case of occupational asthma and
rhinitis in a laboratory worker caused by the inhalation of 100% BSA powder. The patient had a high
serum-spercific IgE level to BSA, and experienced severe systemic reactions, including eye itching,
conjunctivitis, rhinorrhea, nasal obstruction, sneezing, shortness of breath, bronchospasm and
decreased blood pressure. It was suggested an IgE-mediated response as the pathogenic mechanism.
(3)
Based on the available data, the criteria for classification are not satisfied.
CMR effects
Germ cell mutagenicity; Calcium chloride: Genetic toxicity of calcium chloride was negative in the bacterial mutation tests and
(1)
the mammalian chromosome aberration test.
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Reproductive toxicity: Calcium chloride: No reproductive toxicity study has been reported. A developmental toxicity study
equivalent to an OECD Guideline Study reveals no toxic effects on dams or fetuses at doses up to 189
mg/kg bw/day (mice), 176 mg/kg bw/day (rats) and 169 mg/kg bw/day (rabbits). (1)
Carcinogenesis: Substances listed in the National Toxicology Program (NTP) Report on Carcinogens, in the International
Agency for Research on Cancer (IARC) Monographs or found to be potential carcinogen by OSHA:
Substance OSHA IARC NTP
No component listed
STOT –single exposure Not available.
STOT – repeated exposure Calcium chloride: A study for repeated dose oral toxicity in rats shows no adverse effect of calcium
chloride on rats fed 20 mg CaCl2/g diet (comparable to 1000 mg/kg bw/day or more) for 12 months.(1)
Aspiration hazards Not available.
Other information: Not available.
Reasons for the lack of classification:
Where the mixture resulted in a non-classification, this may be due to the availability of data which does not impose a classification for
that specific end-point, or due to lack of data, or due to availability of inconclusive data or data which are not sufficient to get a
classification as for the criteria adopted in Regulations mentioned in this data sheet.
SECTION 12. ECOLOGICAL INFORMATION
The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are
provided bellow.
12.1 Toxicity species, media, units, test duration and test conditions. Related to
(1)
Acute toxicity with fish: LC50 Pimephales promelas= 4,630 mg/l/96 hours Calcium chloride
Chronic toxicity with fish: Not available
(1)
Acute toxicity with crustaceans: EC50 Daphnia magna = 1062 mg/L/48 hr Calcium chloride
(1)
Chronic toxicity with The chronic toxicity study with Daphnia magna shows that a 16% impairment Calcium chloride
crustaceans: of reproduction (EC16) is caused at the concentration of 320 mg/L.
(1)
Acute toxicity with algae: EC50 Selenastrum capricornutum = 2900 mg/L/72 hours (biomass) Calcium chloride
Chronic toxicity with algae: Not available
Toxicity data on soil micro- and Not available
macroorganisms
Toxicity data on birds, bees and Not available
plants:
12.2 Persistency and The methods for determining the biological degradability are not applicable to inorganic substances.
degradability: Once emitted into the environment, calcium chloride, which has a high water solubility, will dissociate
into the calcium cation and the chloride anion. The calcium ion may bind to soil particulate or may
form stable inorganic salts with sulphate and carbonate ions.
12.3 Bioaccumulation potential: Considering its dissociation properties, Calcium chloride per se is not expected to accumulate in living
organisms.
12.4 Mobility in soil: The chloride ion is mobile in soil and eventually drains into surface water because it is readily dissolved
in water.
12.5 Results of PBT and vPvB Not performed.
assessment
12.6 Other toxic effects: Not available.
SECTION 13. DISPOSAL CONSIDERATION
National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected.
13.1 Waste treatment methods
Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws.
SECTION 14. TRANSPORT INFORMATION
Not classified in accordance with ADR/RID, IMDG, IATA and DOT regulations.
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SECTION 15. REGULATORY INFORMATION
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
EU Regulations
●
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of
workers at work (Official Journal L 183 , 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements.
●
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal
protective equipment.
●
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical
agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131 ,
05/05/1998 P. 0011 – 0023.
●
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
●
Commission Regulation (EU) 2015/830 of 28 May 2015 amending Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
●
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December on classification, labelling and packaging
of substances and mixtures 2008 (and subsequent amendments and supplements).
Restriction of use: none
Substance(s) under authorization: none
US Federal Regulations:
State Components listed Note
Massachusetts No component listed
New York No component listed
New Jersey No component listed
Pennsylvania No component listed
California Prop. 65
Ingredient name Cancer Reproductive NSRL or MADL (µg/day)
No component listed
Clean Water Act (CWA) 307 No component listed

Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs) No component listed
Clean Air Act Section 602 Class I Substances No component listed
Clean Air Act Section 602 Class II Substances No component listed
DEA List I Chemicals (Precursor Chemicals) No component listed
DEA List II Chemicals (Essential Chemicals) No component listed
EPA List of Lists

CAS No./SARA/ SARA/ SARA/ CERCLA SARA/EPCRA RCRA CAA 112(r)
IV V VII
Regulatory Name 313 Category EPCRA 302 EPCRA 304 RQ 313 TRI Code RMP TQ
I II III VI
Code EHS TPQ EHS RQ
No component listed
I
SARA/313 Category Code: Emergency Planning and Community Right-to Know Act Section 313 Category Code
II I
SARA/EPCRA 302 EHS TPQ: Extremely Hazardous Substance Threshold Planning Quantity (Emergency Planning and Community Right-to Know Act
Section 302 Category Code)
III I
SARA/EPCRA 304 EHS RQ: Extremely Hazardous Substance Reportable Quantity (Emergency Planning and Community Right-to Know Act Section
304 Category Code)
IV
CERCLA RQ: Reportable Quantity (Comprehensive Environmental Response, Compensation, and Liability Act)
VI
SARA/EPCRA 313 TRI: Toxics Release Inventory (Emergency Planning and Community Right-to Know Act Section 313 Category Code)
VI
RCRA Code: Resource Conservation and Recovery Act Code
VII
CAA 112(r) RMP TQ: Risk Management Plan Threshold Quantity (Clean Air Act Section 112(r))
United States Inventory (TSCA 8b): All components are listed or exempted.
Canada Domestic Substances List (DSL): All components are listed.
15.2 Chemical safety assessment: A chemical safety assessment has not been carried out for the mixture by the supplier.
SECTION 16. OTHER INFORMATION
Revisions: ▪ Edition n. 01, dated 10/06/2010.

▪ Revision n. 01, dated 03/16/2011.
▪ Revision n. 02, dated 10/20/2015. Main changes are in sections 2 to16, adapting the SDS format
and contents to Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012),
Hazardous Product Regulation HPR (WHMIS 2015), and Regulation (EU) 2015/830 of 28 May 2015.
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Acronyms: ACGIH: American Conference of Governmental Industrial Hygienists

AIHA: American Industrial Hygiene Association
ADR: Agreement concerning the carriage of dangerous goods by Road
BCF: Bioaccumulative factor
BEI : Biological Esposure Indices
CAS: Chemical Abstract Service (division of the American Chemical Society
CLP: Classification, Labeling and Packaging
DNEL: Derived No-Effect Levels
EC50: the effect concentration associated with 50% response.
EINECS: European Inventory of Existing Commercial Substances
EPA: US Environmental Protection Agency
IARC: International Agency for Research on Cancer
IATA: International Air Transport Association Code
IMDG: International Maritime Dangerous Goods Code
LC50: Lethal Concentration to 50 % of a test population
LD50: Lethal Dose to 50% of a test population (Median Lethal Dose)
LOEL: Lowest Observed Effect Level
MADL: Maximum Allowable Daily (or Dose) Level
NOAEL: No Observed Adverse Effect Level)
NOEC: no observed effect concentration, means the test concentration immediately below the
lowest tested concentration with statistically significant adverse effect.
NSRL: National Science Research Laboratory
NTP: National Toxicology Program
OEL: Occupational Exposure Limit
OSHA: Occupational Safety and Health Administration
PPE : Personal protective Equipment
PBT: Persistent, Bioaccumulative and Toxic substances
PNEC: Predicted No Effect Concentration
RID: Regulation concerning the International carriage of Dangerous goods by rail
TLV/TWA: Threshold Limit Value/Threshold Weighted Average
vPvB: very Persistent, very Bioaccumulative
WEEL: Workplace Environmental Exposure Level (air concentration of agents in a healthy worker's
breathing zone)
Information related to the Regulation EC/1272/2008:
Hazard statement(s): H315: Causes skin irritation.
H319: Causes serious eye irritation.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335: May cause respiratory irritation.
Information on workers training: Follow National requirements to ensure protection of human health and the environment.
Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008,
according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to HPR (WHMIS 2015) :
Classification: Classification procedure
May cause allergy or asthma symptoms or breathing difficulties if inhaled. (H334) Cut-off method
The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR
1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR
(WHMIS 2015) as recommended by Health Canada (HC).
Bibliographic references:
(1
Calcium Chloride, SIDS Initial Assessment Report For SIAM 15 Boston, USA 22-25th October 2002
(2)
Calcium chloride anh., Registration dossier, available at: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb43f6f-23a1-5205-e044-
00144f67d031/AGGR-dc2ba8fd-c7fc-402e-906e-b6cd0864ad5e_DISS-9eb43f6f-23a1-5205-e044-00144f67d031.html#AGGR-dc2ba8fd-c7fc-402e-
906e-b6cd0864ad5e
(3)
http://e-aair.org - Allergy, Asthma and Immunology Research (AAIR) 2009, October, Occupational asthma caused by inhalation of bovine serum
albumin powder, Case report
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Product Name: S-2765 +I-2581
526 Route 303
1.4 Emergency phone: +44 (0) 3700 492 795
+1 215 207 0061 (USA and Canada)

This product is not hazardous according to Regulations (EC) No 1272/2008, OSHA 29 CFR 1910.1200 and Hazardous Product Regulation
HPR (WHMIS 2015).
according to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
Not classified
For exposure limits see section 8.
Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment.
Hazard pictogram(s): None

Signal word(s): None
Hazard statement(s): None
Precautionary statement(s): None
Safety data sheet available on request. (EUH210)
inhalation) for the human health and for the aquatic environment.
Use the product in accordance with the Good Laboratory Practice.

Safety precautions:
Wear suitable protective clothing, gloves and eye/face protection.
Do not let the product enter drainage system, surface and ground-water or soil. Do not empty into drains.

Page 10 of 26
S-2765 + I-2581 Revision: 02
CO: 459894
Edited on: 10/20/2015
Composition: solid containing organic components.

Classification
HPR (WHMIS 2015)
Dipotassium [[N,N'-ethylenebis[N- 239-803-8 15708-48-2 5-6% Eye damage/Eye Irritation, cat.2A Eye Irrit. 2, H319
(carboxymethyl)glycinato]](4-)- Skin Corrosion/Irritation, cat. 2 Skin Irrit.2, H315
N,N',O,O',ON,ON']magnesate(2-) Specific target organ Toxicity – STOT SE 3, H335
Single Exposure, cat.3
p-nitroaniline *** 202-810-1 100-01-6 < 0.0001%*** Acute Toxicity – Oral, cat. 3 Acute Tox. 3, H331
Index N. (Annex VI of CLP Reg.): Acute Toxicity – Dermal, cat. 3 Acute Tox. 3, H311
612-012-00-9 Acute Toxicity – Inhalation, cat. 3 Acute Tox. 3, H301
Specific target organ Toxicity – STOT RE 2, H373
Repeated Exposure, cat. 3 Aquatic Chronic 3,
Aquatic Chronic 3** H412
**Environmental classification according to Reg. N. 1272/2008 (EC) and subsequent amendments.
***p-nitroaniline, including the proportion of p-nitroaniline from Na-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-p-nitroanilide
dihydrochloride. Na-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-p-nitroanilide dihydrochloride is readily split by specific enzymes and
releases p-nitroaniline.
The mixture contains one substance listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA:
p-Nitroaniline. See Section 11 and 15.

medical advice if adverse symptoms appear.
Acute: Inhalation: may cause irritation to respiratory ways.
Medical monitoring: Not foreseen.

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Hazardous combustion products: Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, NOx.

7.3 Specific end use S-2765 +I-2581 is intended for in vitro diagnostic use. Use the product in accordance with the Good
Laboratory Practice.

Community/National occupational exposure limit values:
p-Nitroaniline (1) Limit value – 8 hours Limit value – short term
Austria 1 ppm; 6 mg/m3
Belgium 3 mg/m3
Denmark 0.5 ppm; 3 mg/m3 1 ppm; 6 mg/m3
Finland 1 ppm; 5.7 mg/m3 3 ppm; 17 mg/m3 - 15 minutes average value
France 3 mg/m3
Hungary 6 mg/m3
Ireland 3 mg/m3
Latvia 0.1 mg/m3
Poland 3 mg/m3 10 mg/m3
Spain 3 mg/m3 - skin
Switzerland 0.5 ppm; 3 mg/m3
Page 12 of 26
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United Kingdom [6 mg/m3]

The UK Advisory Committee on Toxic Substances has expressed concern that, for the OELs shown in parentheses
[..], health may not be adequately protected because of doubts that the limit was not soundly-based. These OELs
were included in the published UK 2002 list and its 2003 supplement, but are omitted from the published 2005
list.
Canada - Ontario 3 mg/m3
Canada - Quebec 3 mg/m3
New Zealand 3 mg/m3
USA - NIOSH 3 mg/m3
USA - OSHA 1 ppm; 6 mg/m3
Australia 3 mg/m3
ACGIH (1992)(2): TLV/TWA: 3 mg/m3 (skin). Notation: A4: not classifiable as a human carcinogen.
IDLH(3): 300 mg/m3
Community/National biological exposure limit values:
P-Nitroaniline (6): Methemoglobin inducers: Determinant: methemoglobin in blood; BEI = 1.5% of hemoglobin. Sampling time: during
or end of shift.
DNEL values (components):
Workers Consumers
Component Route of exposure Acute effects Chronic effects Acute effects Chronic effects
local systemic local systemic local systemic local systemic
P-Nitroaniline (4) Oral (mg/(mg/kg bw/day 0.201
Dermal (mg/kg bw/day) 0.1763 0.04347
Inhalation (mg/m3) 0.201 0.05
PNEC values (components): P-Nitroaniline (4) PNEC aqua freshwater = 0.024 mg/l
PNEC aqua marine water = 0.0024 mg/l
PNEC aqua intermittent release = 0.24 mg/l
PNEC STP = 1 mg/l
PNEC sediment freshwater = 64.247424 mg/kg sediment dw
PNEC sediment marine water = 64.247424 mg/kg sediment dw
PNEC soil = 25.961088 mg/kg soil dw
methods.
Page 13 of 26
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Value Related to
Appearance: solid
Odor: not available
Color: White to off white
pH: 7.4-7.6 Mixture
Flammability: not available
Explosive properties: not available
Oxidizing properties: not available
Density: not available
Water Solubility: Soluble Mixture
Melting point/range: not available
9.2 Other information not available
8°C.
reactions
10.4 Conditions to avoid: Keep out from heat, water, humidity, and light.
10.5 Incompatible materials Strong oxidizing agents.
10.6 Hazardous decomposition Thermal decomposition or combustion may include toxic and hazardous fumes of COx, NOx.
products:
bellow.
Dermal: Prolonged or repeated skin contact may cause irritation.
Inhalation: Inhalation of the product may cause irritation to respiratory ways.
Contact with eyes: May cause irritation.
4-Nitroaniline : is readily absorbed orally, by inhalation and dermally and is eliminated in the form of numerous metabolites essentially
via the kidneys. 4-Nitroaniline is rapidly distributed into all tissues. (5)
(4)
Oral: LD50 (wild bird) = 75 mg/Kg p-nitroaniline
(4)
LD50 (rat) = 750 – 3,250 mg/Kg p-nitroaniline
(4)
Dermal: LD50 (rat) > 500 mg/Kg p-nitroaniline
LD50 (guinea pig) > 500
(7)
Inhalation: LC50 (rat) = 2.53 mg/l/4h Read across from 2-nitroaniline p-nitroaniline
Other data: p-Nitroaniline causes the formation of MetHb. Due to the formation of methemoglobin (MetHb), is
capable of significantly disturbing the oxygen supply in organs and tissues. This can induce hypoxic
effects. (5)(6)
Page 14 of 26
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Skin Corrosion/Irritation p-Nitroaniline: When applied to rabbits' skin (test according to OECD guideline 404), there were slight
erythema and yellow discoloration short-term. Both effects were reversible within 24 hours. (10)
According to Aggregated Computational Toxicology Resource (ACToR) database; 4-nitroaniline was not
found to be irritating to the skin of rabbit. (8)
Serious eye damage/ irritation p-Nitroaniline: application to rabbits' eyes (test according to OECD guideline 405) led to only short-
term reddening of the conjunctiva and the effects were reversible within 24 hours.(10)
Sensitization:
Skin sensitization: p-Nitroaniline: No significant skin sensitization potential by 4-nitroaniline can be derived, either from
(5)
the few results with humans described in literature, or from the results of animal studies.
Respiratory sensitization: p-Nitroaniline: No significant respiratory sensitization potential by 4-nitroaniline can be derived, either
from the few results with humans described in literature, or from the results of animal studies. (5)
CMR effects
Germ cell mutagenicity; p-Nitroaniline: Various tests with the substance in microorganisms and mammalian cells produced
positive but sometimes inconsistent results. p-Nitroaniline was ascribed to have a genotoxic potential in
vitro but two in-vivo tests had negative results. Summarizing, the data pool available is insufficient to
assess the mutagenic potential of N. (6)
Reproductive toxicity: p-Nitroaniline: produced no evidence of adverse reproductive performance, including mating, fertility
and pregnancy, littering or pup survival and development, in a two-generation rat reproduction study
using a dosage which produced significant maternal toxicity (increased spleen weight, anemia, elevated
blood methemoglobin levels) related to methemoglobinia following chronic dosing. p-Nitroaniline is not
considered to cause a primary effect on fetal development. (8)

No component listed
p-Nitroaniline: In a two-year study, the administration of p-Nitroaniline to mice by gavage showed
inconclusive evidence of carcinogenic activity in male mice, based to increased incidence of
haemangiomas of the liver and haemangiosarcomas or haemangiosarcomas (combined) in other
locations. In female mice is not observed evidence of carcinogenic activity. (9)(6)
STOT – repeated exposure p-Nitroaniline: The repeated exposure to p-Nitroaniline can cause methemoglobinemia and hemolysis,
anemia and jaundice, liver damage. (9)(6)
Other information:
provided bellow.
(4)
Acute toxicity with fish: LC50 Brachydanio rerio = 87.6 mg/l/96 hours p-nitroaniline
(4)
Acute toxicity with crustaceans: EC50 crustaceans = 24 mg/l/48hours p-nitroaniline
Chronic toxicity with Not available
crustaceans:
(4)
Acute toxicity with algae: EC50 = 68 mg/l/24 h p-nitroaniline
Chronic toxicity with algae: Not available
Toxicity data on soil micro- and Not available
macroorganisms
Page 15 of 26
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Edited on: 10/20/2015

plants:
12.2 Persistency and p-nitroaniline is not biodegradable and is expected to have moderate persistence potential.(7)
degradability:
(7)
12.3 Bioaccumulation potential: p-nitroaniline is are expected to have low bioaccumulation potential.
12.4 Mobility in soil: p-Nitroaniline: If released to soil, is expected to have high mobility, based upon Koc values of 54-87.
(10)
12.5 Results of PBT and vPvB Not available.

assessment
EU Regulations
●
●
●
05/05/1998 P. 0011 – 0023.
●
●
●
Massachusetts p-Nitroaniline -
New York p-Nitroaniline -
Mutagen
New Jersey p-Nitroaniline
Reactive* - Second Degree
Pennsylvania p-Nitroaniline Environmental Hazard
* “Reactive” is used interchangeably with the NFPA term “instability.”
California Prop. 65
No component listed

Page 16 of 26
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Edited on: 10/20/2015
EPA List of Lists

CAS No./SARA/ SARA/ EPCRA 302 SARA/ EPCRA CERCLA SARA/EPCRA RCRA CAA 112(r)
Regulatory Name
313 Category Code I EHS TPQ II 304EHS RQ III RQ IV 313 TRI V Code VI RMP TQ VII
p-Nitroaniline 100-01-6 - - 5000 313 P077 -
I
II I
III I
304 Category Code)
IV
VI
VI
VII

▪ Revision n. 01, dated 03/16/2011.
▪ Revision n. 02, dated 10/20/2015. Main changes are in sections 2 to16, adapting the SDS format and
contents to Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012), Hazardous
Product Regulation HPR (WHMIS 2015), and Regulation (EU) 2015/830 of 28 May 2015.
NOEC: no observed effect concentration, means the test concentration immediately below the lowest
tested concentration with statistically significant adverse effect.
breathing zone)
Page 17 of 26
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Hazard statement(s): H331: Toxic if inhaled.
H311: Toxic in contact with skin.
H301: Toxic in contact with skin.
H373: May cause damage to organs through prolonged or repeated exposure.
H412: Harmful to aquatic life with long lasting effects.
H315: Causes skin irritation.
H335: May cause respiratory irritation.
Not classified -
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29
CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation
HPR (WHMIS 2015) as recommended by Health Canada (HC).
(1)
GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx
(2)
ACGIH, TLVs and BEIs based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents &
Biological Exposure Indices, 2012
(3)
OSHA Occupational Chemical Database, https://www.osha.gov/chemicaldata/chemResult.html?recNo=2
(4)
4-nitroaniline, Registration dossier on ECHA, available at http://apps.echa.europa.eu/registered/data/dossiers/DISS-d018ef27-b601-3c5c-
e044-00144f67d249/AGGR-7af23cd1-289d-4962-8eda-cbf579986b83_DISS-d018ef27-b601-3c5c-e044-00144f67d249.html#AGGR-7af23cd1-
289d-4962-8eda-cbf579986b83
(5)
The MAK Collection for Occupational Health and Safety Published Online: 14 AUG 2014, available at
http://onlinelibrary.wiley.com/doi/10.1002/3527600418.mb10001e3014/pdf
(6)
GESTIS Substance database, 4-Nitroaniline, ZVG 17030
(7)
U.S. Environmental Protection Agency September, 2009 Hazard Characterization Document, SCREENING-LEVEL HAZARD
CHARACTERIZATION Mononitroanilines Category , 2-Nitrobenzenamine (CASRN 88-74-4) , 4-Nitrobenzenamine (CASRN 100-01-6)
(8)
High Productio Volume Chemical Challenge program, test Plan for the Mononitroaniline category, Solutia Inc.
(9)
http://www.salute.gov.it/sicurezzaChimica, MSDS for p-nitroaniline, Code RE 1623
(10)
Hazardous Substances Data Bank (HSDB), p-Nitroaniline, HSN: 1156
Page 18 of 26
BUFFER, STOCK SOLUTION Revision: 02
CO: 459894
Edited on: 10/20/2015

Product Name: BUFFER, STOCK SOLUTION
526 Route 303
1.4 Emergency phone: +44 (0) 3700 492 795
+1 215 207 0061 (USA and Canada)

This product is not hazardous according to Regulations (EC) No 1272/2008, OSHA 29 CFR 1910.1200 and Hazardous Product Regulation
HPR (WHMIS 2015).
According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and
Not classified
For exposure limits see ch. 8
Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment.
Hazard pictogram(s): None

Signal word(s): None
Hazard statement(s): None
Precautionary statement(s): None
Safety data sheet available on request. (EUH210)
inhalation) for the human health and the aquatic environment.

Warning:
The product contains bovine material. All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem
health inspection by a veterinarian, and they were apparently free from infectious and contagious material. However, the material should
be treated as potentially infectious.
Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma symptoms or breathing difficulties if inhaled.
Page 19 of 26
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Edited on: 10/20/2015
Composition: liquid containing organic and inorganic components, bovine material.

Classification
HPR (WHMIS 2015)
Tris Hydrochloride 214-684-5 1185-53-1 2.5-2.6 % Skin Corrosion/Irritation, cat. 2 Skin Irrit. 2, H315
Eye damage/Eye Irritation, cat. 2B Eye Irrit. 2, H319
Tris-Hydroxymethyl aminomethane 201-064-4 77-86-1 0.9-1 % Skin Corrosion/Irritation,cat. 2 Skin Irrit. 2, H315
(Tris Amino)
The mixture does not contain substances listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP,
OSHA. See Section 11 and 15.

medical advice if adverse symptoms appear.
Acute: Inhalation: May cause irritation to the mucous membranes and upper respiratory tract.
The product contains bovine serum albumin, might cause might cause allergic skin reaction and/or
allergy or asthma symptoms or breathing difficulties if inhaled.
Medical monitoring: Not foreseen.

Hazardous combustion products: Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, NOx, SOx,
HBr, HCl.
Page 20 of 26
CO: 459894
Edited on: 10/20/2015

7.3 Specific end use BUFFER, Stock Solution is intended for in vitro diagnostic use. The product contains bovine material.
All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem
health inspection by a veterinarian, and they were apparently free from infectious and contagious
material. Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma
symptoms or breathing difficulties if inhaled. However, the material should be treated as potentially
infectious. Use the product in accordance with the Good Laboratory Practice.

Community/National occupational exposure limit values: Not established.
Community/National biological exposure limit values: Not established.
DNEL values (components): Not established.
PNEC values (components): Not established.
methods.
Page 21 of 26
CO: 459894
Edited on: 10/20/2015

Value Related to
Appearance: Liquid/clear
Odor: not available
Color: Slightly yellow
pH: 7.8-8.0 Mixture
Flammability: Aqueous solution, not expected to be flammable
Explosive properties: Aqueous solution, not expected to be explosive
Oxidizing properties: Aqueous solution, not expected to be oxidant
Density: Not available
Water Solubility: Miscible Mixture
Melting point/range: Liquid, not applicable
9.2 Other information
Miscibility miscible
8 °C.
reactions
10.4 Conditions to avoid: Keep away from heat and light.
10.5 Incompatible materials Strong oxidising agents.
10.6 Hazardous decomposition Thermal decomposition or combustion may generate toxic and hazardous fumes of COx, SOx, HCl,
products: HBr, NOx.
bellow.
Dermal: May cause skin irritation.
Inhalation: May cause irritation to the mucous membranes and upper respiratory tract.
Contact with eyes: May cause eye irritation.
Other: The product contains bovine serum albumin; might cause might cause allergic skin reaction and/or
allergy or asthma symptoms or breathing difficulties if inhaled.
Tris amino: is not metabolized appreciably and is eliminated by the kidneys. Ionized tromethamine is excreted by kidney, so the effect is
that of excretion of hydrogen ions. Elimination of drug from body is entirely by renal excretion. It is not known whether tromethamine is
distributed into human milk. (1)
Page 22 of 26
CO: 459894
Edited on: 10/20/2015

(2)
Oral: LD50 (rat) > 3,000 mg/kg Tris Amino
(3)
Dermal: LD50 (rat) > 5,000 mg/kg Tris Amino
Inhalation: not available
Other: not available

Skin Corrosion/Irritation Tris Amino: Tromethamine was a mild irritant to rabbits at 25% with a pH of 10.8. At 40%,
tromethamine was not irritating. Intradermal injections of tromethamine were severely irritating to
rabbits at pH 10.4 but were only mildly irritating at pH 7.4. The supporting substance 2-Amino-2-
methyl-1-Propanol (AMP) was found to be irritating to rabbits, with burrowing lesions noted when
applied to abraded skin sites; there was mild irritation noted when applied to unabraded skin.(2)
Tris Hydrochloride: irritant to skin (read across from Tris Amino).
(2)
Serious eye damage/ irritation Tris Amino (100%) was not an ocular irritant when administered to rabbits.
(5)
Tris Hydrochloride : mild eye irritant in rabbits.
Sensitization:
(2)
Skin sensitization: Tris Amino: The supporting chemical AMP is not sensitizing to guinea pig skin.
(5)
Tris Hydrochloride: Not a sensitizer in experimental animals.
Bovine serum albumin (BSA), which is present in bovine plasma, could develop allergic skin reactions in
laboratory workers after dealing with BSA powder. Based on the available data, the criteria for
classification are not satisfied.
Respiratory sensitization: Bovine serum albumin (BSA), which is present in bovine plasma, could develop allergic reactions in
laboratory workers after dealing with BSA powder. It is reported a case of occupational asthma and
rhinitis in a laboratory worker caused by the inhalation of 100% BSA powder. The patient had a high
serum-spercific IgE level to BSA, and experienced severe systemic reactions, including eye itching,
conjunctivitis, rhinorrhea, nasal obstruction, sneezing, shortness of breath, bronchospasm and
decreased blood pressure. It was suggested an IgE-mediated response as the pathogenic mechanism.
(7)
Based on the available data, the criteria for classification are not satisfied.
CMR effects
Germ cell mutagenicity; Tris Amino: The supporting chemical, AMP, was not mutagenic to bacteria and mammalian cells in vitro,
and did not induce micronuclei in mice in vivo.
Tris Hydrochloride: Ames test negative.(6)
Reproductive toxicity: Tris Amino: In an oral gavage combined reproductive/developmental toxicity screening test in rats no
effects on reproductive or developmental parameters were observed at the doses tested; the NOAEL for
reproductive and developmental toxicity is 1000 mg/kg-day, the highest dose tested. (2)
No component listed
(4)
Tris Amino: based on the available data, the substance is not carcinogenic.
STOT – repeated exposure There are no documented long-term effects of Tris Amino treatment, and no serious side-effects on
record that are directly attributed to treatment with the compound. (3)
Other information: Not available.
Page 23 of 26
CO: 459894
Edited on: 10/20/2015
provided bellow.
(2)
Acute toxicity with fish: LC50 Leuciscus idus > 10,000 mg/L/ 96-h Tris Amino
(1)
Acute toxicity with crustaceans: Water fleas (Daphnia magna) were exposed to AMP at unspecified concentrations Tris Amino
for 48 hours. LC50 = 193 mg/L/48 h.
(6)
EC50 daphnia > 100 mg/l/48h Tris HCl
Chronic toxicity with Not available
crustaceans:
(2)
Acute toxicity with algae: EC50 Selenastrum capricornutum >100 mg/L/ 96 h Tris Amino
Chronic toxicity with algae: Not available.
Toxicity data on soil micro- and Not available.
macroorganisms
plants:
(1)
12.2 Persistency and Tris Amino is not readily biodegradable is expected to have moderate persistence.
degradability:
Tris Hydrochloride: readily biodegradable. (6)
(1)
12.3 Bioaccumulation potential: Tris-Hydroxymethyl aminomethane is expected to have low bioaccumulation potential.
(2)
12.4 Mobility in soil: Tris Amino is expected to have high mobility in soil.
12.5 Results of PBT and vPvB Not performed.
assessment
EU Regulations
●
●
●
05/05/1998 P. 0011 – 0023.
●
●
●
Page 24 of 26
CO: 459894
Edited on: 10/20/2015
Massachusetts No component listed
New York No component listed
New Jersey No component listed -
Pennsylvania No component listed
California Prop. 65
No component listed

EPA List of Lists

CAS No./SARA/ SARA/ SARA/ CERCLA SARA/EPCRA RCRA CAA 112(r)
IV V VII
Regulatory Name 313 Category EPCRA 302 EPCRA 304 RQ 313 TRI Code RMP TQ
I II III VI
Code EHS TPQ EHS RQ
No component listed
I
II I
III I
304 Category Code)
IV
VI
VI
VII
Protac: Not listed on the TSCA Inventory. It is for research and development use only.

▪ Revision n. 01, dated 03/16/2011
▪ Revision n. 02, dated 10/20/2015. Main changes are in sections 2 to16, adapting the SDS format and
contents to Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012), Hazardous
Product Regulation HPR (WHMIS 2015), and Regulation (EU) 2015/830 of 28 May 2015.
Page 25 of 26
CO: 459894
Edited on: 10/20/2015

NOEC: no observed effect concentration, means the test concentration immediately below the lowest
tested concentration with statistically significant adverse effect.
breathing zone)
Hazard statement(s): H315: Causes skin irritation.
Not classified -
1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29
CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation
HPR (WHMIS 2015) as recommended by Health Canada (HC).
(1)
HSDB Hazardous Substances Databank, Tromethamine
(2)
Screening-Level Hazard Characterization, Sponsored chemical 2-Amino-2-hydroxymethyl-1,3-propanediol (TRIS AMINO) CASRN 77-
86-1, U.S. Environmental Protection Agency, Hazard Characterization Document, September, 2014
(3)
ECHA, Registration Dossier, Tromethamine, http://apps.echa.europa.eu/registered/data/dossiers/DISS-d7f60455-0965-1602-e044-
00144f67d031/AGGR-932e53a4-4218-4161-b380-2c99a562941f_DISS-d7f60455-0965-1602-e044-00144f67d031.html#AGGR-932e53a4-4218-
4161-b380-2c99a562941f
(4)
TEST PLAN For Tris(hydroxymethy1)aminomethane (77-86-1) Submitted to the U.S. Environmental Protection Agency Under the
High Production Volume (HPV) Chemicals Challenge Program The Dow Chemical Company Midland, Michigan, 48674
(5)
Haz-Map, Tromethamine hydrochloride, available at http://hazmap.nlm.nih.gov/category-details?table=copytblagents&id=18456
(6)
Sigma Aldrich, SDS for Tromethamine Hydrochloride, Version 5.0, revision date 17.10.2013
(7)
http://e-aair.org - Allergy, Asthma and Immunology Research (AAIR) 2009, October, Occupational asthma caused by inhalation of
bovine serum albumin powder, Case report
Page 26 of 26

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SAFETY DATA SHEET Doc.

IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY

Identification of the product

INFORMATION ON COMPOSITION/HAZARD OF THE PRODUCT

000H00455 S-2765+I-2581 Not classified Not classified 1 x 6 mL

Prepared by: Chemsafe Srl

SECTION 1. IDENTIFICATION OF THE MIXTURE AND OF THE COMPANY

1.1 Identification of the mixture

SECTION 2. HAZARDS IDENTIFICATION

2.1 Classification of the mixture:

Signal word(s): Danger

2.3 Other hazards (which do not results in the classification)

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

SECTION 4. FIRST AID MEASURES

4.1 Description of first aid measures

SECTION 5. FIRE-FIGHTING MEASURES

5.1 Extinguishing media

SECTION 6. ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment and emergency procedures

6.4 Reference to other sections See also section 8 and 13.

SECTION 7. HANDLING AND STORAGE

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters

PNEC values (components): Not established.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES

9.1 Information on basic physical and chemical properties

SECTION 10. STABILITY AND REACTIVITY

SECTION 11. TOXICOLOGICAL INFORMATION

SECTION 12. ECOLOGICAL INFORMATION

SECTION 13. DISPOSAL CONSIDERATION

SECTION 14. TRANSPORT INFORMATION

SECTION 15. REGULATORY INFORMATION

Clean Water Act (CWA) 307 No component listed

EPA List of Lists

SECTION 16. OTHER INFORMATION

Revisions: ▪ Edition n. 01, dated 10/06/2010.

Acronyms: ACGIH: American Conference of Governmental Industrial Hygienists

SECTION 1. IDENTIFICATION OF THE MIXTURE AND OF THE COMPANY

1.1 Identification of the mixture

SECTION 2. HAZARDS IDENTIFICATION

2.1 Classification of the mixture:

Hazard pictogram(s): None

Use the product in accordance with the Good Laboratory Practice.

2.3 Other hazards (which do not results in the classification)

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS

Composition: solid containing organic components.

SECTION 4. FIRST AID MEASURES

4.1 Description of first aid measures

SECTION 5. FIRE-FIGHTING MEASURES

5.1 Extinguishing media

5.2 Special hazards arising from the substance or mixture

SECTION 6. ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment and emergency procedures

6.4 Reference to other sections See also section 8 and 13.

SECTION 7. HANDLING AND STORAGE

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters

United Kingdom [6 mg/m3]

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES