Registration Dossier

Guidance on Safe Use

Guidance on Safe Use

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Administrative data

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.

Most important symptoms and effects, both acute and delayed:

Symptoms : Nausea, vomiting, Diarrhea, Central nervous system disorders, Irritations, Hematological disorders, Sedation, Drowsiness, Neurological disorders.

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

Advice for firefighters:
Special protective equipment for firefighters: Use self-contained breathing apparatus.

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

Accidental release measures

Personal precautions, protective equipment and emergency procedures:
Appropriate gas full face respirator or air supplied hood depending on released quantities. Dedicated work clothes. Suitable gloves.

Environmental precautions:
Avoid any spreading of the product. Protect sewage.

Methods and materials for containment and cleaning up:
General advice : Take up with absorbent material (eg sand, kieselguhr, universal binder) 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 recommended.

Handling and storage

Precautions for safe handling:
Advice on safe handling (industrial scale): Local ventilation and emission point fume extraction. Enclosed transfer recommended.
Take precautionary measures against electrostatic loading. Earth vessels and equipment well.

Advice on safe handling (laboratory scale): Handling in a hood.

Conditions for safe storage, including any incompatibilities:
Requirements for storage areas and containers: Keep in a 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. Provide for a retention basin.

Storage temperature : Keep at ambient temperature (+15 to +25°C).

Recommended packaging materials: Glass, polyethylene, polypropylene.Stainless steel.

Packaging materials to be avoided : Metals which can be attacked like iron, aluminium, etc.

Sensitivity: No particular observation.

Transport information

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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

Control parameters:
Occupational Exposure Limits:
OEL-8h (Sanofi): : 100 μg/m3
Remarks : (approved)
Sanofi hazard bands-Hygiene : OEB V3 G1 (approved)

Exposure controls:
Personal protective equipment
(IMPORTANT: to be adapted following the workplace risk assessment.)
Special recommendations : Pregnant women, seek medical advice before handling.

Industrial workplace:

Respiratory protection : Appropriate gas full face respirator or powered-air purifying respirator.

Hand protection :
Suitable gloves.
Glove material : Butyl rubber
Layer thickness : 0,7 mm
Break through time: > 480 min

Eye/face protection : See respiratory protection.
Body Protection : Dedicated working clothes recommended.
Additional technical information on the plant : Use under strictly controlled conditions.

Hygiene measures : Wash hands.

Laboratory:

Respiratory protection : Handling in a hood.
Hand protection : Suitable gloves.
Eye/face protection : Safety glasses.
Body Protection : Working clothes.
Hygiene measures : Wash hands.

Stability and reactivity

Safety remarks : No particular observation.
Reactivity : No data available
Chemical stability : No data available
Possibility of hazardous reactions: No data available
Conditions to avoid : Avoid strong heating.
Incompatible materials : Strong oxidizing agents. Many metals.
Hazardous decomposition products: Supposed thermal decomposition/oxidation: Carbon monoxide and carbon dioxide

Disposal considerations

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

Uncleaned empty packaging : Deliver to the Environmental service of the factory or to any specialized and approved disposal service.