Registration Dossier

Administrative data

First-aid measures

General information: IF exposed or concerned: Get medical advice/attention. Ensure that medical personnel are aware
of the material(s) involved, and take precautions to protect themselves. Show this safety data
sheet to the doctor in attendance. For personal protection.

Inhalation: Move to fresh air. Call a physician if symptoms develop or persist. For breathing difficulties, oxygen
may be necessary.

Skin contact: Wash off with soap and water. Get medical advice/attention if you feel unwell. If skin irritation or
rash occurs: Get medical advice/attention. Wash contaminated clothing before reuse.

Eye contact: Do not rub eyes. 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 immediately

Ingestion: Rinse mouth. Call a physician or poison control centre immediately. Only induce vomiting at the
instruction of medical personnel. Never give anything by mouth to an unconscious person.

Most important symptoms and effects, both acute and delayed: Severe eye irritation. Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Permanent eye damage including blindness could result. May cause respiratory irritation.

Indication of any immediate medical attention and special treatment needed: Provide general supportive measures and treat symptomatically. Symptoms may be delayed.

Fire-fighting measures

General fire hazards: May form explosible dust-air mixture if dispersed. Strong dust explosion characteristic. Very high
sensitivity of a dust cloud to ignition, based on minimum ignition energy.

Suitable extinguishing media: Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2). Apply extinguishing media
carefully to avoid creating airborne dust. Avoid high pressure media which could cause the
formation of a potentially explosible dust-air mixture.

Unsuitable extinguishing media: Do not use water jet as an extinguisher, as this will spread the fire.

Special hazards arising from the substance or mixture: Explosion hazard: Avoid generating dust; fine dust dispersed in air in sufficient concentrations and in the presence of an ignition source is a potential dust explosion hazard. During fire, gases hazardous to health may be formed.

Special protective equipment for firefighters: Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

Special fire fighting procedures: In case of fire and/or explosion do not breathe fumes. Move containers from fire area if you can do
so without risk.

Specific methods: Use standard firefighting procedures and consider the hazards of other involved materials.

Accidental release measures

For non-emergency personnel: Keep unnecessary personnel away. Local authorities should be advised if significant spillages
cannot be contained.

For emergency responders: Ensure adequate ventilation. Wear appropriate protective equipment and clothing during clean-up.
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Ventilate the
contaminated area. ELIMINATE all ignition sources (no smoking, flares, sparks or flames in
immediate area). Do not breathe dust. Do not get in eyes, on skin, or on clothing. Do not touch
damaged containers or spilled material unless wearing appropriate protective clothing.

Environmental precautions: Avoid release to the environment. Inform appropriate managerial or supervisory personnel of all
environmental releases. Prevent further leakage or spillage if safe to do so. Avoid discharge into
drains, water courses or onto the ground.

Methods and material for containment and cleaning up:
-Ensure adequate ventilation. Avoid the generation of dusts during clean-up. ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area). Ground container and transfer equipment to eliminate static electric sparks. Avoid use of a filtered vacuum to clean spills of dry solids, due to the potential for electrostatic discharge and the strong dust explosion potential and very high sensitivity to ignition. Prevent product from entering drains.
-Large Spills: Stop the flow of material, if this is without risk. Collect spill with an inert, non-combustible absorbent material and transfer to labeled container for disposal. Clean contaminated surface thoroughly.
-Small Spills: Wipe up with a damp cloth and place in container for disposal. Clean surface thoroughly to remove residual contamination.
-Never return spills to original containers for re-use.

Handling and storage

Precautions for safe handling: Ensure adequate ventilation. Ignition of a dust cloud produces a very strong explosion. Prevent
dust accumulation to minimize explosion hazard. Avoid significant deposits of material, especially
on horizontal surfaces, which may become airborne and form combustible dust clouds and may
contribute to secondary explosions. Routine housekeeping should be instituted to ensure that
dusts do not accumulate on surfaces. Static electricity and formation of sparks must be prevented.
Dry powders can build static electricity charges when subjected to the friction of transfer and
mixing operations. Provide adequate precautions, such as electrical grounding and bonding, or
inert atmospheres. Ground container and transfer equipment to eliminate static electric sparks. Do
not handle, store or open near an open flame, sources of heat or sources of ignition. Protect
material from direct sunlight. Provide appropriate exhaust ventilation at places where dust is
formed. Do not breathe dust. Do not get in eyes, on skin, or on clothing. Avoid prolonged
exposure. Wear appropriate personal protective equipment. Observe good industrial hygiene
practices. When using, do not eat, drink or smoke. Wash thoroughly after handling. Wash
contaminated clothing before reuse. Avoid release to the environment.

Conditions for safe storage, including any incompatibilities: Keep containers tightly closed in a dry, cool and well-ventilated place. Do not store in direct
sunlight. Keep away from heat and sources of ignition. Take measures to prevent the build up of
electrostatic charge. Dry powders can build static electricity charges when subjected to the friction
of transfer and mixing operations. Prevent electrostatic charge build-up by using common bonding
and grounding techniques. Store away from incompatible materials.

Specific end use(s): Not available.

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

EXPOSURE PARAMETERS
Biological limit values: No biological exposure limits noted for the ingredient(s).

Recommended monitoring procedures: Follow standard monitoring procedures.

Derived no effect levels (DNELs): None available.

Predicted no effec concentrations (PNECs): None available.

Exposure guidelines OEL Additional Information: Severe Eye Irritant

EXPOSURE CONTROLS
Appropriate engineering controls: Provide adequate general and local exhaust ventilation. Good general ventilation (typically 10 air
changes per hour) should be used. Ventilation rates 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. If engineering measures are not
sufficient to maintain concentrations of dust particulates below the OEL (occupational exposure
limit), suitable respiratory protection must be worn. If material is ground, cut, or used in any
operation which may generate dusts, use appropriate local exhaust ventilation to keep exposures
below the recommended exposure limits. 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: Wear safety glasses with side shields (or goggles) and a face shield. (Ref: EN 166).

Skin protection
- Hand protection: Wear appropriate chemical resistant gloves. (Ref: EN 374). Use protective gloves made of: Nitrile.
or Polyvinyl chloride (PVC). for limited exposure.
- Other: Wear suitable protective clothing. Use protective clothing (uniforms, lab coats, disposable
coveralls, etc.) in both production and laboratory areas. Impervious protective clothing is
recommended if skin contact with drug product is possible and for bulk processing operations.
(Ref: EN 13982-1 in case of dust).

Respiratory protection: In case of insufficient ventilation, wear suitable respiratory equipment. If the applicable
Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection
factor sufficient to control exposures to below the OEL. Respiratory protection should be provided
in instances where exposure to dust, mists, aerosols or vapors are likely. Chemical respirator with
organic vapour cartridge, full facepiece, dust and mist filter. (Ref: EN 136). Use a positive-pressure
air-supplied respirator if there is any potential for an uncontrolled release, exposure levels are not
known, or any other circumstances where air-purifying respirators may not provide adequate
protection.

Thermal hazards: Wear appropriate thermal protective clothing, when necessary.

Hygiene measures: When using, do not eat, drink or smoke. Always observe good personal hygiene measures, such
as washing after handling the material and before eating, drinking, and/or smoking. Routinely
wash work clothing and protective equipment to remove contaminants.

Environmental exposure controls: Environmental manager must be informed of all major releases.

Stability and reactivity

Reactivity: The product is stable and non-reactive under normal conditions of use, storage and transport.

Chemical stability: Material is stable under normal conditions.

Possibility of hazardous reactions: No dangerous reaction known under conditions of normal use.

Conditions to avoid: Contact with incompatible materials. Strong dust explosion characteristic. Avoid conditions which
create dust. Keep away from heat, spark, open flames and other sources of ignition. Very high
sensitivity of a dust cloud to ignition, based on minimum ignition energy. Take measures to prevent
the build up of electrostatic charge. Minimise dust generation and accumulation.

Incompatible materials: Strong oxidising agents.

Hazardous decomposition products: Irritating and/or toxic fumes and gases may be emitted upon the product's decomposition. Thermal decomposition products may include oxides of carbon, nitrogen, and sulfur.

Disposal considerations

Waste treatment methods
Residual waste: 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.

Contaminated packaging: 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: Avoid release to the environment. Do not discharge into drains, water courses or onto the ground.
Do not allow this material to drain into sewers/water supplies. Considering the relevant known
environmental and human health hazards of the material, review and implement appropriate
technical and procedural waste water and waste disposal measures to prevent occupational
exposure and environmental release. It is recommended that waste minimization be practiced.
The best available technology should be utilized to prevent environmental releases. This may
include destructive techniques for waste and wastewater. Dispose of contents/container in
accordance with local/regional/national/international regulations.

Special precautions: Dispose in accordance with all applicable regulations.