Registration Dossier

Administrative data

First-aid measures

Description of first aid measures:
General advice: Move out of dangerous area. Remove contaminated clothing immediately and dispose of safely.
If inhaled: Move to fresh air. Make the victim blow his nose. Seek medical advice immediately.
In case of skin contact: Rinse immediately with plenty of water for at least 15 minutes. Seek medical advice immediately.
In case of eye contact: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Seek medical advice immediately.
If swallowed: Do not induce vomiting. Call emergency medical care. In case of acute poisoning, lie the victim in half upright position. Put the victim under medical supervision. Keep the victim warm.

Most important symptoms and effects, both acute and delayed
Symptoms: Nausea, vomiting. Drowsiness.

Indication of any immediate medical attention and special treatment needed
Treatment: No data available. Treat symptomatically.

Fire-fighting measures

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

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) Hydrogen chloride (HCl)

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.

Accidental release measures

Personal precautions, protective equipment and emergency procedures:
Insulating breathing apparatus and chemical suit.

Environmental precautions:
Avoid any spreading of the product.

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.

Reference to other sections:
Additional advice: Evacuation of area and intervention of special services.

Handling and storage

Precautions for safe handling:
Advice on safe handling (industrial scale): Local ventilation and emission point dust extraction. Enclosed transfer strongly recommended. Work in a defined area with restricted access recommended. Take precautionary measures against electrostatic loading. Earth vessels and equipment well.
Advice on safe handling (laboratory scale): Handling in a fume cupboard. Work in a defined area with restricted access recommended.

Conditions for safe storage, including any incompatibilities:
Requirements for storage rooms and vessels: Keep in a cool, well-ventilated place.
Advice on common storage: Keep away from chemicals as it is a pharmaceutical substance
Further information on storage conditions: Keep in a well closed container, away from moisture and light.
Storage temperature: Keep at room temperature (below 30°C).
Advised packaging material: Glass, plastic, stainless steel.
Sensitivity: The product is sensitive to light.

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

Occupational Exposure Limits:
OEL-8h (Sanofi): 7 μg/m3

Personal protection equipment
(IMPORTANT: to be adapted following the workplace risk assessment.)
Special recommendations: Pregnant women, seek medical advice before handling. Specific dermal hazard: avoid any contact with skin. Warning drivers of machines on risks of drowsiness.

Industrial workplace
Respiratory protection: Air supplied hood.
Hand protection: Doubled gloves recommended. Glove material : Nitrile rubber Layer thickness : 0,11 mm Break through time: > 480 min
Eye/face protection: See respiratory protection.
Body Protection: Dedicated protective suit.
Hygiene measures: Shower recommended.

Laboratory
Respiratory protection: Handle in a fume cupboard.
Hand protection: Suitable gloves.
Eye/face protection: Safety glasses.
Body Protection: Dedicated working clothes recommended.
Hygiene measures: Wash hands.

Stability and reactivity

Safety remarks: Dust may be explosive (no data available).
Reactivity: No data available.
Chemical stability: No data available.
Possibility of hazardous reactions: No data available.
Conditions to avoid: No data available.
Incompatible materials: Strong oxidizing agents.
Hazardous decomposition products: Supposed thermal decomposition/oxidation: Carbon monoxide and carbon dioxide Nitrogen oxides (NOx) Hydrogen chloride (HCl)

Disposal considerations

Product: Deliver to the Environmental service of the factory or to any specialized and approved disposal service. Classified as NARCOTIC drug. Alert the competent authority.
Uncleaned packaging: Deliver to the Environmental service of the factory or to any specialized and approved disposal service. Make the container unusable.