Safety Data Sheet in accordance with Regulation (EC) n°1907/2006

HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015

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

1.1. Product identifier

Product name: HYDROXOCOBALAMIN

Synonyms: RU3141

CAS-No.: 13422-51-0

1.2. Relevant identified uses of the substance or mixture and uses advised against
Active ingredient for medical use.

Pharmacological activity:
Substance pharmacologically active. Hematopoietic vitamin.
1.3. Details of the supplier of the safety data sheet
Name : Sanofi

Street address : 54, rue La Boétie  75008 Paris

FR

Telephone : +33153774000

Telefax : +33153774133

Safety data sheet prepared by: "Product Stewardship France" - Tel : 33 1 41 24 51 77 [email protected]

1.4. Emergency telephone number : + 33 1 45 42 59 59 (ORFILA)

SECTION 2. Hazards identification

2.1. Classification of the substance or mixture:

CLP/GHS Classification (REGULATION (EC) No 1272/2008)
Not a dangerous substance according to GHS.

DSD/DPD Classification (EU Directives 67/548/EEC or 1999/45/EC) [The product is classified and labelled in
accordance with EC Directives]

R-phrase(s) -: -
2.2. Label elements:

CLP/GHS-Labelling (REGULATION (EC) No 1272/2008)

Hazard statements -: -

Precautionary statements
P260: Do not breathe dust.
P262: Do not get in eyes, on skin, or on clothing.
P314: Get medical advice/ attention if you feel unwell.
P402 + P404: Store in a dry place. Store in a closed container.
P411: Store at temperatures not exceeding 8°C .
P501: Dispose of contents/ container to an approved waste disposal plant.

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
DSD/DPD Labelling in accordance with 67/548/EEC or 1999/45/EC (The product is classified and labelled in
accordance with EC Directives)

R-phrase(s) -: -

S-phrase(s) S 7/8: Keep container tightly closed and dry.

S22: Do not breathe dust.
S24/25: Avoid contact with skin and eyes.
S47.8: Keep at temperature not exceeding 8 °C.

2.3. Other hazards:

Physical, chemical and : Low risk of dust explosion.

toxicological hazards
Environmental effects : No data available on environmental effects.

Sanofi hazard bands:

Hygiene : OEB 2 (approved)

Safety : SHB 2
Further information see chapter 16.

SECTION 3. Composition/information on ingredients

3.1. Substances:
Product Description : Co.alpha-[alpha-(5,6-dimethylbenzimidazolyl)]-Co.beta-hydroxocobamide
CAS-No. : 13422-51-0
EINECS-No. : 236-533-2
Molecular formula : C62 H89 Co N13 O15 P

SECTION 4. First aid measures

4.1. Description of first aid measures:

General advice : Take the victim out of the contaminated area. Remove contaminated clothing
immediately and dispose of safely.

If inhaled : Move to fresh air. Make the victim blow his nose. Seek medical advice.

In case of skin contact : Rinse immediately with plenty of water for at least 15 minutes. Seek medical
advice.

In case of eye contact : Rinse immediately with plenty of water, also under the eyelids, for at least 15
minutes. Seek medical advice.

If swallowed : Do NOT induce vomiting. Make the victim rinse his mouth with water. Seek
medical advice.

4.2. Most important symptoms and effects, both acute and delayed
Symptoms : Red urine coloration.
Headache.
Fever.
Allergic reactions

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
4.3. Indication of any immediate medical attention and special treatment needed

SECTION 5. Firefighting measures

5.1. Extinguishing media:

Suitable extinguishing media : All means (e.g. water, carbon dioxide, dry chemical extinguisher).

Unsuitable extinguishing media : Strong water jet.

5.2. Special hazards arising from the substance or mixture:

In case of fire, the product may emit toxic and/or irritating fumes.
Supposed thermal decomposition/oxidation:
Carbon monoxide and carbon dioxide
Nitrogen oxides (NOx)
Phosphorus compounds
Inorganic oxide(s) and carbonate(s)

5.3. Advice for firefighters:

Special protective equipment : Use self-contained breathing apparatus. Wear full protective suit.

Further information : Use extinguishing measures that are appropriate to local circumstances and
the surrounding environment. Avoid discharging extinguishing water in the
environment.

SECTION 6. Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures:

Particle filter half mask, filter P3. Safety glasses. Suitable gloves. Work clothes.

6.2. Environmental precautions:

Avoid spreading of product.

6.3. Methods and materials for containment and cleaning up:

General advice : Sweep and shovel the solid product into a container specially adapted for its
recovery or destroying (avoiding dust formation). Close and label thoroughly.

Cleaning of contaminated zone : After cleaning up the product, rinse the polluted area with water.

Elimination of recovered materials : Deliver to the Environmental service of the factory or to any specialized and
approved disposal company.

6.4. Reference to other sections:

Additional advice:

Intervention of special services recommended.

SECTION 7. Handling and storage

7.1. Precautions for safe handling:

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
Advice on safe handling (industrial : Handling in a hood recommended.
scale) Take precautionary measures against electrostatic loading. Earth vessels and
equipment well.

Advice on safe handling : Handling in a hood recommended.

(laboratory scale)

7.2. Conditions for safe storage, including any incompatibilities:

Requirements for storage rooms : Keep in a cool, well-ventilated place.

and vessels

Advice on common storage : Keep away from chemicals as it is a pharmaceutical substance

Further information on storage : Keep away from heat. Keep in a well closed container, away from moisture
conditions and light.

Storage temperature : Keep at temperature not exceeding 46 °F (8°C.)

Advised packaging material : Glass, polyethylene, polypropylene.

Sensitivity
Light : The product is sensitive to light.
Humidity : strongly hygroscopic

7.3. Specific end use(s):

SECTION 8. Exposure controls/personal protection

8.1. Control parameters:

Occupational Exposure Limits:

OEL-8h (Sanofi): : 300 µg/m3

Remarks : (approved)

Sanofi hazard bands-Hygiene : OEB 2 (approved)

Further information see chapter 16.

8.2. Exposure controls:

Personal protection equipment
(IMPORTANT: to be adapted following the workplace risk assessment.)

Industrial Workplace

Respiratory protection : Particle filter (P3) half mask recommended.

Hand protection : Suitable gloves.

Glove material : Nitrile rubber
Layer thickness : 0,11 mm
Break through time: > 480 min

Eye/face protection : Safety glasses.

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
Body protection : Work clothes.

Hygiene measures : Wash hands.

Laboratory

Respiratory protection : Handling in a hood recommended.

Hand protection : Suitable gloves recommended.

Eye/face protection : Safety glasses.

Body Protection : Working clothes.

Hygiene measures : Wash hands.

SECTION 9. Physical and chemical properties

9.1. Information on basic physical and chemical properties:

Physical state : Solid

Form : powder
Colour : dark red
Odour : odourless
Molar mass : 1.346,41 g/mol

Melting point : > 300 °C

Flash point : Not applicable.

Thermal decomposition : 190 °C

Method: under nitrogen

105 °C
Method: under oxygen

Minimum ignition energy : MIE > 1000 mJ (very low sensitivity to ignition).

Vapour pressure : No data available.

Density : No data available.

Bulk density : approx. 360 kg/m3

Solubility in water : Sparingly soluble in water.

Solubility/qualitative : Soluble in alcohols.

pH value : 8 - 10
at 20 g/l

Octanol/water partition coefficient : No data available.

9.2. Other information:

Resistivity : > 1E14 Ohm.m (extremely insulating solid).

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
Decay time : < 1 hour (very dissipative solid).

SECTION 10. Stability and reactivity

Safety remarks : Low risk of dust explosion.

10.1. Reactivity : No data available.

10.2. Chemical stability : No data available.

10.3. Possibility of hazardous : Unknown.

reactions

10.4. Conditions to avoid : No data available.

10.5. Incompatible materials : Strong oxidizing agents.

10.6. Hazardous decomposition : Supposed thermal decomposition/oxidation:

products Carbon monoxide and carbon dioxide
Nitrogen oxides (NOx)
Phosphorus compounds
Inorganic oxide(s) and carbonate(s)

Sanofi hazard bands-Safety : SHB 2

Further information see chapter 16.

SECTION 11. Toxicological information

11.1. Information on toxicological effects

Acute toxicity

Acute oral toxicity : > 2.000 mg/kg

(LD50) Species: mouse
Data relate to a (another) salt.

Acute intravenous toxicity (IV) : > 50 mg/kg

(LD50) Species: Mouse

Skin corrosion/irritation : May be irritating to human skin.

Serious eye damage/-irritation : May be irritating to human eyes.

Respiratory or skin sensitisation : May produce an allergic reaction.

No experimental data available. No cases reported at workplace.

Specific target organ toxicity : No data available.

(STOT) - Single exposure

Aspiration hazard : Not applicable.

Chronic/Long-term toxicity

Germ cell mutagenicity : No data available.

Carcinogenicity : No data available.

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015
Reproductive toxicity : No teratogenic effects in animal studies.

Specific target organ toxicity : No data available.

(STOT) - repeated exposure

Further information:

Pharmacological activity : Substance pharmacologically active. Hematopoietic vitamin.

Other toxicity data : Red urine coloration.

Headache.
Fever.
Coughing, dyspnea (respiratory disorders).

SECTION 12. Ecological information

12.1. Toxicity:

Acute invertebrates toxicity : No data available.

12.2. Persistence and degradability:

Biological degradability : No data available.

12.3. Bioaccumulative potential:

Bioaccumulation : No data available.

12.4. Mobility in soil:

Behaviour in environmental : No data available.

compartments

12.5. Results of PBT and vPvB assessment:

Results of PBT and vPvB : No data available.

assessment

12.6. Other adverse effects:

Note : Ecological data not available.

Do not release material and cleaning waters into the environment.

SECTION 13. Disposal considerations

13.1. Waste treatment methods:

Product : Deliver to the Environmental service of the factory or to any specialized and
approved disposal service.

Uncleaned packaging : Recycling possible after cleaning.

Deliver to the Environmental service of the factory or to any specialized and
approved disposal service.

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015

SECTION 14. Transport information

Land transport
ADR: Not classified as dangerous in the meaning of transport regulations.

Sea transport
IMDG: Not classified as dangerous in the meaning of transport regulations.

Air transport
IATA: Not classified as dangerous in the meaning of transport regulations.

SECTION 15. Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture:

15.2. Chemical Safety Assessment:

SECTION 16. Other information

Version : 2.4 Revision date 27.01.2015

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.

Note: major information modified since the last version of the sheet are marked by a vertical line in front of the relevant change.

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 Safety Data Sheet in accordance with Regulation (EC) n°1907/2006
HYDROXOCOBALAMIN
Substance key: FR01676 Version:2.4 (World) Revision Date: 27.01.2015

Definition of Sanofi-OEB:
OEB is the occupational exposure band with the following levels (solids - a similar but distinct scale is used for liquids, named
OEB V):

Occupational Exposure Occupational Exposure

Band Level
OEB 1 > 1000 µg/m³
OEB 2 100 - 1000 µg/m³
OEB 3 10 – 100 µg/m³
OEB 4 1 – 10 µg/m³
OEB 5 < 1 µg/m³

Additional notations may be applied as suffixes to the OEL/OEB and are used to communicate additional information that is not
directly indicated by the OEL/OEB classifications. This information is necessary to perform an efficient risk assessment and
determine the correct exposure controls. The meanings of the suffixes is explained in this way:

Notation/Suffixes Danger
Reprotoxic Hazard for pregnant women. Exposure below the OEL is
G1
acceptable.
G2 Hazard for pregnant women. Exposure even below the OEL is not acceptable.
Respiratory sensitization hazard with serious potential consequences
Sr
(anaphylactic reactions).
Sk Specific dermal hazard (High dermal absorption / Danger of skin sensitization).
Corrosive compound - Important dermal and ocular hazard If corrosive
Cor
compounds.

Définition of SHB and EHB:

Substances are classified on a scale from 1, the less hazardous, to 5, the most hazardous, according to their safety properties,
eg explosivity, flammability, etc. (SHB) and ecotoxicological properties, eg persistance, ecotoxicity (EHB)

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