SAFETY DATA SHEET

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

1.1. Product identifier
Trade name or designation VIDAS High sensitive Troponin I - STR (X10)
of the mixture
Registration number -
Synonyms None.
SDS number 1307
Product code 415386
Issue date 27-November-2015
Version number 01
1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses In vitro diagnostic medical device
Uses advised against None known.
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 uktechnical@biomerieux.com

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 gcs_immunomarcy@biomerieux.com

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 Regulation (EC) No 1272/2008 as amended
Health hazards
Serious eye damage/eye irritation Category 1 H318 - Causes serious eye
damage.

Hazard summary Causes serious eye damage. Harmful if swallowed. Causes skin irritation. Irritating to eyes.
Prolonged exposure may cause chronic effects. Occupational exposure to the substance or
mixture may cause adverse health effects.
2.2. Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains: Diethanolamine
Hazard pictograms

Signal word Danger

Material name: VIDAS High sensitive Troponin I - STR (X10) SDS UK

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 Hazard statements
H318 Causes serious eye damage.
Precautionary statements
Prevention
P280 Wear protective gloves/protective clothing/eye protection/face protection.
Response
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
Storage Not available.
Disposal Not available.
Supplemental label information None.
2.3. Other hazards None known.

SECTION 3: Composition/information on ingredients

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

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

203-868-0
Classification: Acute Tox. 4;H302, Skin Irrit. 2;H315, Eye Dam. 1;H318, Carc. 2;H351, STOT RE
2;H373, Aquatic Chronic 3;H412

Sodium azide < 0.2 26628-22-8 01-2119457019-37-XXXX 011-004-00-7 #

247-852-1
Classification: Acute Tox. 2;H300, Acute Tox. 1;H310, Aquatic Acute 1;H400, Aquatic Chronic 1;H410

Other components below reportable levels 90 - 100

List of abbreviations and symbols that may be used above
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
4.1. Description of first aid measures
Inhalation
Skin contact
Eye contact
Ingestion
4.2. Most important symptoms
and effects, both acute and
delayed
4.3. Indication of any
immediate medical attention
and special treatment needed
Get medical attention if symptoms occur. Show this safety data sheet to the doctor in attendance.
If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing.
For breathing difficulties, oxygen may be necessary. Call a physician if symptoms develop or
persist.
Not available.
Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if
present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists.
IF SWALLOWED: Immediately call a POISON CENTRE or doctor/physician. Rinse mouth. Never
give anything by mouth to a victim who is unconscious or is having convulsions. Do not induce
vomiting without advice from poison control center. If vomiting occurs, keep head low so that
stomach content doesn't get into the lungs. Get medical attention if symptoms occur.
Severe eye irritation. Symptoms may include stinging, tearing, redness, swelling, and blurred
vision. Skin irritation. May cause redness and pain.
Provide general supportive measures and treat symptomatically.

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
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 Unsuitable extinguishing Not available.
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 Not available.
procedures
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency Keep unnecessary personnel away. Wear appropriate protective equipment and clothing during
personnel clean-up. Do not breathe vapour. Do not touch damaged containers or spilled material unless
wearing appropriate protective clothing. For personal protection, see section 8.
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: Stop the flow of material, if this is without risk. Dike the spilled material, where this is
containment and cleaning up possible. Absorb in vermiculite, dry sand or earth and place into containers. Following product
recovery, flush area with water.

Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to
remove residual contamination.

Never return spills to original containers for re-use.

6.4. Reference to other For personal protection, see section 8. For waste disposal, see section 13 of the SDS.
sections

SECTION 7: Handling and storage

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

SECTION 8: Exposure controls/personal protection

8.1. Control parameters
Occupational exposure limits
UK. EH40 Workplace Exposure Limits (WELs)
Components Type Value
Sodium azide (CAS STEL 0.3 mg/m3
26628-22-8)
TWA 0.1 mg/m3
EU. Indicative Exposure Limit Values in Directives 91/322/EEC, 2000/39/EC, 2006/15/EC, 2009/161/EU
Components Type Value
Sodium azide (CAS STEL 0.3 mg/m3
26628-22-8)
TWA 0.1 mg/m3
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)

Exposure guidelines
UK EH40 WEL: Skin designation
Sodium azide (CAS 26628-22-8) Can be absorbed through the skin.
8.2. Exposure controls
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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. Eye
wash facilities and emergency shower must be available when handling this product.
Individual protection measures, such as personal protective equipment
General information Use personal protective equipment as required. Personal protection equipment should be chosen
according to the CEN standards and in discussion with the supplier of the personal protective
equipment.
Eye/face protection Avoid contact with eyes. Wear safety glasses with side shields (or goggles). Eye wash fountain is
recommended.
Skin protection
- Hand protection Wear protective gloves. Use protective gloves made of: Nitrile.
- Other Wear suitable protective clothing. Wear protective gloves.
Respiratory protection Do not breathe dust/fume/gas/mist/vapors/spray. In case of insufficient ventilation, wear suitable
respiratory equipment.
Thermal hazards Not applicable.
Hygiene measures Wash hands after handling.
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.
Form Not available.
Colour Colourless to light yellow.
Odour Not available.
Odour threshold Not available.
pH 9.2
Melting point/freezing point Not available.
Initial boiling point and boiling Not available.
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not applicable.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Vapour pressure Not available.
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.
Decomposition temperature Not available.
Viscosity Not available.
Explosive properties Not available.
Oxidising properties Not available.
9.2. Other information No relevant additional information available.

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SECTION 10: Stability and reactivity
10.1. Reactivity
10.2. Chemical stability
10.3. Possibility of hazardous
reactions
10.4. Conditions to avoid
10.5. Incompatible materials
10.6. Hazardous
decomposition products
The product is stable and non-reactive under normal conditions of use, storage and transport.
Material is stable under normal conditions.
No dangerous reaction known under conditions of normal use.
Contact with incompatible materials.
Strong acids.
No hazardous decomposition products are known.

SECTION 11: Toxicological information

General information Occupational exposure to the substance or mixture may cause adverse effects.
Information on likely routes of exposure
Inhalation Prolonged inhalation may be harmful.
Skin contact Causes skin irritation.
Eye contact Causes serious eye damage.
Ingestion Harmful if swallowed.
Symptoms Severe eye irritation. Symptoms may include stinging, tearing, redness, swelling, and blurred
vision. Skin irritation. May cause redness and pain.
11.1. Information on toxicological effects

Acute toxicity Harmful if swallowed.

Components Species Test results
Diethanolamine (CAS 111-42-2)
Acute
Dermal
LD50 Rabbit 11.9 ml/kg
Oral
LD50 Rat 710 mg/kg
Sodium azide (CAS 26628-22-8)
Acute
Dermal
LD50 Rabbit 20 mg/kg
Oral
LD50 Bird 23.7 mg/kg
Mouse 27 mg/kg
Rat 27 mg/kg
TD Rat 5460 mg/kg

* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Causes skin irritation.
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.
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.

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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
Sodium azide (CAS 26628-22-8)
Aquatic
Crustacea EC50 Water flea (Daphnia pulex) 2.8 - 6.2 mg/l, 48 hours
Fish LC50 Bluegill (Lepomis macrochirus) 0.68 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
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
Contaminated packaging
EU waste code
Disposal methods/information
Special precautions
Dispose of in accordance with local regulations. Empty containers or liners may retain some
product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions). Avoid discharge into water courses or onto the ground.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied. Empty containers should be taken to an approved waste handling site for recycling or
disposal.
Waste codes should be assigned by the user based on the application for which the product was
used. The Waste code should be assigned in discussion between the user, the producer and the
waste disposal company.
Collect and reclaim or dispose in sealed containers at licensed waste disposal site. This material
and its container must be disposed of as hazardous waste. Must be incinerated in a suitable
incineration plant holding a permit delivered by the competent authorities. Dispose of
contents/container in accordance with local/regional/national/international regulations.
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 established.
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 and II, as amended
Not listed.
Regulation (EC) No. 850/2004 On persistent organic pollutants, Annex I as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 1 as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 2 as amended
Not listed.
Regulation (EU) No. 649/2012 concerning the export and import of dangerous chemicals, Annex I, Part 3 as amended
Not listed.
Regulation (EU) No. 649/2012 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, as amended
Not listed.
Regulation (EC) No. 1907/2006, REACH Article 59(10) 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, as amended
Not listed.
Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are
breastfeeding, as amended
Not listed.
Other EU regulations
Directive 2012/18/EU on major accident hazards involving dangerous substances
Sodium azide (CAS 26628-22-8)
Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at
work, as amended
Diethanolamine (CAS 111-42-2)
Sodium azide (CAS 26628-22-8)
Directive 94/33/EC on the protection of young people at work, as amended
Diethanolamine (CAS 111-42-2)
Sodium azide (CAS 26628-22-8)
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 Young people under 18 years old are not allowed to work with this product according to EU
Directive 94/33/EC on the protection of young people at work. 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.

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Information on evaluation
method leading to the
classification of mixture
Full text of any H-statements
not written out in full under
Sections 2 to 15
Revision information
Training information
Disclaimer
Material name: VIDAS High sensitive Troponin I - STR (X10)
415386 Version #: 01 Issue date: 27-November-2015
The classification for health and environmental hazards is derived by a combination of calculation
methods and test data, if available.
H300 Fatal if swallowed.
H302 Harmful if swallowed.
H310 Fatal in contact with skin.
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.
H400 Very toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
H412 Harmful to aquatic life with long lasting effects.
None.
Follow training instructions when handling this material.
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. bioMérieux SA cannot anticipate all
conditions under which this information and its product, or the products of other manufacturers in
combination with its product, may be used. It is the user’s responsibility to ensure safe conditions
for handling, storage and disposal of the product, and to assume liability for loss, injury, damage or
expense due to improper use. The information in the sheet was written based on the best
knowledge and experience currently available.
SDS UK
8/8