SAFETY DATA SHEET

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier
Trade name or designation VIDAS D-DIMER Exlusion II - STR (X10)
of the mixture
Article Reference 30 455
Registration number -
SDS number 999
Issue date 18-December-2013
Version number 01
1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses In vitro diagnostic medical device
1.3. Details of the supplier of the safety data sheet
Supplier
Company name bioMerieux UK Limited
Address Grafton Way, Basingstoke
Hampshire RG22 6HY
Telephone (44) 1256.461881
Fax (44) 1256.816863
e-mail [email protected]
Manufacturer
Company name bioMérieux SA
Address Chemin de l'Orme - 69280 Marcy-l'Etoile - France
Telephone +33(0)478877656
Fax +33(0)478872080
e-mail [email protected]
1.4. Emergency telephone 999 or Call a POISON CENTRE or doctor/physician
number

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture
The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification
applies.
Classification according to Directive 67/548/EEC or 1999/45/EC as amended
Classification Xi;R36
The full text for all R-phrases is displayed in section 16.
Hazard summary
Physical hazards Not classified for physical hazards.
Health hazards Irritating to eyes.
Environmental hazards Not classified for hazards to the environment.
Specific hazards Prolonged exposure may cause chronic effects.
Main symptoms Irritation of eyes and mucous membranes. Permanent eye damage including blindness could
result. Symptoms may include stinging, tearing, redness, swelling, and blurred vision.
2.2. Label elements
Label according to Directive 67/548/EEC or 1999/45/EC as amended

Irritant
R-phrase(s)
R36 Irritating to eyes.

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 S-phrase(s)
S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
Authorisation number None.
Supplemental label information Not applicable.
2.3. Other hazards None known.

SECTION 3: Composition/information on ingredients

3.2. Mixtures
General information
Chemical name % CAS-No. / EC No. REACH Registration No. INDEX No. Notes

Diethanolamine 5 - < 10 111-42-2 01-2119488930-28XXXX 603-071-00-1

203-868-0
Classification: DSD: Xn;R22-48/22, Xi;R38-41
CLP: Acute Tox. 4;H302, Skin Irrit. 2;H315, Eye Dam. 1;H318, Carc. 2;H351, STOT RE 2;H373,
Aquatic Chronic 3;H412

Other components below reportable levels 90 - 100

CLP: Regulation No. 1272/2008.
DSD: Directive 67/548/EEC.
M: M-factor
vPvB: very persistent and very bioaccumulative substance.
PBT: persistent, bioaccumulative and toxic substance.
#: This substance has been assigned Community workplace exposure limit(s).
Composition comments The full text for all R- and H-phrases is displayed in section 16.

SECTION 4: First aid measures

General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to
protect themselves.
4.1. Description of first aid measures
Inhalation Move to fresh air. Call a physician if symptoms develop or persist.
Skin contact Wash off with soap and water. Get medical attention if irritation develops and persists.
Eye contact Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. Call a physician or poison control centre immediately.
Ingestion Rinse mouth. Get medical attention if symptoms occur.
4.2. Most important symptoms Irritation of eyes and mucous membranes. May cause temporary blindness and severe eye
and effects, both acute and damage. Symptoms may include stinging, tearing, redness, swelling, and blurred vision.
delayed
4.3. Indication of any Provide general supportive measures and treat symptomatically. In case of shortness of breath,
immediate medical attention give oxygen. Keep victim warm. Keep victim under observation. Symptoms may be delayed.
and special treatment needed

SECTION 5: Firefighting measures

General fire hazards No unusual fire or explosion hazards noted.
5.1. Extinguishing media
Suitable extinguishing Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2).
media
Unsuitable extinguishing Do not use water jet as an extinguisher, as this will spread the fire.
media
5.2. Special hazards arising During fire, gases hazardous to health may be formed.
from the substance or mixture
5.3. Advice for firefighters
Special protective Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
equipment for firefighters
Special fire fighting Move containers from fire area if you can do so without risk.
procedures

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency Keep unnecessary personnel away. Wear appropriate personal protective equipment. For
personnel personal protection, see section 8.

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 For emergency responders Keep unnecessary personnel away. Use personal protection recommended in Section 8 of the
SDS.
6.2. Environmental precautions Avoid discharge into drains, water courses or onto the ground.
6.3. Methods and material for Large Spills: Absorb in vermiculite, dry sand or earth and place into containers. Following product
containment and cleaning up recovery, flush area with water.

Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to
remove residual contamination.
6.4. Reference to other For personal protection, see section 8. For waste disposal, see section 13.
sections

SECTION 7: Handling and storage

7.1. Precautions for safe Do not breathe vapour. Do not get this material in contact with eyes. Avoid prolonged exposure.
handling Wear appropriate personal protective equipment. Observe good industrial hygiene practices.
Wash hands thoroughly after handling.
7.2. Conditions for safe Store away from incompatible materials (see Section 10 of the SDS). Storage temperature:
storage, including any between 2 °C and 8 °C.
incompatibilities
7.3. Specific end use(s) Not available.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters
Occupational exposure limits No exposure limits noted for ingredient(s).
Biological limit values No biological exposure limits noted for the ingredient(s).
Recommended monitoring Follow standard monitoring procedures.
procedures
Derived no-effect level (DNEL) Not available.

Predicted no effect Not available.

concentrations (PNECs)

8.2. Exposure controls

Appropriate engineering Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates
controls should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation,
or other engineering controls to maintain airborne levels below recommended exposure limits. If
exposure limits have not been established, maintain airborne levels to an acceptable level. Provide
eyewash station.
Individual protection measures, such as personal protective equipment
General information Personal protection equipment should be chosen according to the CEN standards and in
discussion with the supplier of the personal protective equipment. Eye wash fountain is
recommended.
Eye/face protection Wear eye/face protection.
Skin protection
- Hand protection Use protective gloves made of: Nitrile.
- Other Wear suitable protective clothing.
Respiratory protection Do not breathe dust/fume/gas/mist/vapors/spray. When workers are facing concentrations above
the exposure limit they must use appropriate certified respirators.
Thermal hazards Not applicable.
Hygiene measures Handle in accordance with good industrial hygiene and safety practices.
Environmental exposure Environmental manager must be informed of all major releases.
controls

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties
Appearance
Physical state Liquid.
Colour Colourless to light yellow.
Odour Not available.
pH 9.2
Melting point/freezing point Not available.
Initial boiling point and boiling Not available.
range
Flash point Not available.

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Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Vapour pressure 0 hPa estimated
Vapour density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.
Solubility (other) Not available.
Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature Not available.
Explosive properties Not available.
Oxidizing properties Not available.
9.2. Other information
Density 1.11 g/cm3 estimated

SECTION 10: Stability and reactivity

10.1. Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
10.2. Chemical stability Material is stable under normal conditions.
10.3. Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
10.4. Conditions to avoid Contact with incompatible materials.
10.5. Incompatible materials Strong acids.
10.6. Hazardous No hazardous decomposition products are known.
decomposition products

SECTION 11: Toxicological information

General information Occupational exposure to the substance or mixture may cause adverse effects.
Information on likely routes of exposure
Ingestion Expected to be a low ingestion hazard.
Inhalation Prolonged inhalation may be harmful.
Skin contact Not available.
Eye contact Causes serious eye damage.
Symptoms Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Permanent eye
damage including blindness could result.
11.1. Information on toxicological effects

Components Species Test results

Diethanolamine (CAS 111-42-2)
Acute
Dermal
LD50 Rabbit 11.9 ml/kg
Oral
LD50 Rat 710 mg/kg
Other
LD50 Mouse 2300 mg/kg

* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Due to partial or complete lack of data the classification is not possible.
Serious eye damage/eye Causes serious eye damage.
irritation
Respiratory sensitisation Due to partial or complete lack of data the classification is not possible.
Skin sensitisation Due to partial or complete lack of data the classification is not possible.
Germ cell mutagenicity Due to partial or complete lack of data the classification is not possible.
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Carcinogenicity Risk of cancer cannot be excluded with prolonged exposure.
IARC Monographs. Overall Evaluation of Carcinogenicity
Diethanolamine (CAS 111-42-2) 2B Possibly carcinogenic to humans.
Reproductive toxicity Due to partial or complete lack of data the classification is not possible.
Specific target organ toxicity - Due to partial or complete lack of data the classification is not possible.
single exposure
Specific target organ toxicity - Due to partial or complete lack of data the classification is not possible.
repeated exposure
Aspiration hazard Due to partial or complete lack of data the classification is not possible.
Mixture versus substance No information available.
information
Other information Not available.

SECTION 12: Ecological information

12.1. Toxicity The product is not classified as environmentally hazardous. However, this does not exclude the
possibility that large or frequent spills can have a harmful or damaging effect on the environment.
Components Species Test results
Diethanolamine (CAS 111-42-2)
Aquatic
Crustacea EC50 Water flea (Ceriodaphnia dubia) 61.8 - 86.04 mg/l, 48 hours
Fish LC50 Fathead minnow (Pimephales promelas) 100 mg/l, 96 hours

* Estimates for product may be based on additional component data not shown.
12.2. Persistence and No data is available on the degradability of this product.
degradability
12.3. Bioaccumulative potential No data available.
Partition coefficient
n-octanol/water (log Kow)
Diethanolamine -1.43
Bioconcentration factor (BCF) Not available.
12.4. Mobility in soil No data available.
12.5. Results of PBT Not available.
and vPvB
assessment
12.6. Other adverse effects No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation
potential, endocrine disruption, global warming potential) are expected from this component.

SECTION 13: Disposal considerations

13.1. Waste treatment methods
Residual waste Dispose of in accordance with local regulations.
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.
EU waste code The Waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Disposal methods/information Dispose of contents/container in accordance with local/regional/national/international regulations.
Special precautions Dispose in accordance with all applicable regulations.

SECTION 14: Transport information

ADR
Not regulated as dangerous goods.
RID
Not regulated as dangerous goods.
ADN
Not regulated as dangerous goods.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.

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14.7. Transport in bulk Not available.
according to Annex II of
MARPOL 73/78 and the IBC
Code

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
EU regulations
Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I
Not listed.
Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II
Not listed.
Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended
Not listed.
Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended
Not listed.
Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry
Not listed.
Regulation (EC) No. 1907/2006, REACH Article 59(1) Candidate List as currently published by ECHA
Not listed.
Authorisations
Regulation (EC) No. 1907/2006, REACH Annex XIV Substances subject to authorization, as amended
Not listed.
Restrictions on use
Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended
Not listed.
Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at
work
Not listed.
Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are
breastfeeding
Not listed.
Other EU regulations
Directive 96/82/EC (Seveso II) on the control of major-accident hazards involving dangerous substances
Not listed.
Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work
Diethanolamine (CAS 111-42-2)
Directive 94/33/EC on the protection of young people at work
Diethanolamine (CAS 111-42-2)
Other regulations The product is classified and labelled in accordance with EC directives or respective national laws.
This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006.
National regulations Follow national regulation for work with chemical agents.
15.2. Chemical safety No Chemical Safety Assessment has been carried out.
assessment

SECTION 16: Other information

List of abbreviations Not available.
References Not available.
Information on evaluation The classification for health and environmental hazards is derived by a combination of calculation
method leading to the methods and test data, if available.
classification of mixture

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Full text of any statements or
R-phrases and H-statements
under Sections 2 to 15 R22 Harmful if swallowed.
R36 Irritating to eyes.
R38 Irritating to skin.
R41 Risk of serious damage to eyes.
R48/22 Harmful: danger of serious damage to health by prolonged exposure if swallowed.
H302 Harmful if swallowed.
H315 Causes skin irritation.
H318 Causes serious eye damage.
H351 Suspected of causing cancer.
H373 May cause damage to organs through prolonged or repeated exposure.
H412 Harmful to aquatic life with long lasting effects.
Revision information None.
Training information Follow training instructions when handling this material.
Classification according to Regulation (EC) No 1272/2008 as amended
Health hazards
Serious eye damage/eye irritation Category 1 H318 - Causes serious eye
damage.
Disclaimer The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information given is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release and is
not to be considered a warranty or quality specification. The information relates only to the specific
material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text. The information in the sheet was written
based on the best knowledge and experience currently available.

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