Registration Dossier

Administrative data

First-aid measures

General information: IF exposed or concerned: Get medical advice/attention. For personal protection. 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. Wash
contaminated clothing before reuse.

Description of first aid measures
Inhalation: Move to fresh air. Get medical advice/attention if you feel unwell.
Skin contact: Remove contaminated clothing immediately and wash skin with soap and water. If skin irritation or
rash occurs: Get medical advice/attention. Wash contaminated clothing before reuse.
Eye contact: Do not rub eyes. Rinse thoroughly with plenty of water for at least 15 minutes and consult a
physician. Remove contact lenses, if present and easy to do.
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 unconsious person.

Most important symptoms and effects, both acute and delayed:May cause an allergic skin reaction. Dermatitis. Rash. Dusts may irritate the respiratory tract, skin
and eyes. Coughing. Headache. Dizziness. Nausea. Prolonged exposure may cause chronic
effects. Individuals with cardiac conditions may be more susceptible to toxicity in cases of
overexposure.

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: Strong dust explosion characteristic. May form explosible dust-air mixture if dispersed. Very high
sensitivity of a dust cloud to ignition, based on minimum ignition energy. Fine particles (such as
dust and mists) may fuel fires/explosions.

Extinguishing media
- 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.

Advice for firefighters
-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

Personal precautions, protective equipment and emergency procedures
-For non-emergency personnel: Keep unnecessary personnel away. Local authorities should be advised if significant spillages
cannot be contained.
-For emergency responders: Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Ensure
adequate ventilation. ELIMINATE all ignition sources (no smoking, flares, sparks or flames in
immediate area). Avoid the generation of dusts during clean-up. Wear appropriate protective
equipment and clothing during clean-up. Ventilate the contaminated 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. Eliminate all ignition sources (no smoking, flares, sparks, or flames in
immediate area). Take precautionary measures against static discharge. Use only non-sparking
tools. Avoid the generation of dusts during clean-up. Prevent product from entering drains.
-Large Spills: Stop the flow of material, if this is without risk. 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. Absorb with earth, sand or other non-combustible material and
transfer to containers for later disposal. Clean surface thoroughly to remove residual
contamination.
-Small Spills: Absorb spill with vermiculite or other inert material. 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. Provide appropriate exhaust ventilation at places where dust is
formed. Take precautionary measures against static discharges. 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. Minimise dust generation and
accumulation. 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. Do
not handle, store or open near an open flame, sources of heat or sources of ignition. Protect
material from direct sunlight. Wear appropriate personal protective equipment. Do not breathe
dust. Do not get in eyes, on skin, or on clothing. Avoid prolonged exposure. 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. Protect from sunlight. Do not
handle or store near an open flame, heat or other sources of ignition. This material can
accumulate static charge which may cause spark and become an ignition source. 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

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

Recommended monitoring procedures: Follow standard monitoring procedures.

Derived no effect levels (DNELs): Not available.

Predicted no effect concentrations (PNECs): Not available.

Exposure guidelines: OEL Additional Information: Sensitizer - skin

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. Provide eyewash station and safety shower.

- 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).

Skin protection
- Hand protection: Wear appropriate chemical resistant gloves.
- Other: Wear appropriate chemical resistant clothing. Impervious protective clothing is recommended if
skin contact with drug product is possible and for bulk processing operations.

Respiratory protection: Respiratory protection should be provided in instances where exposure to dust, mists, aerosols or
vapors are likely. 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.

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. Contaminated work
clothing should not be allowed out of the workplace.

Environmental exposure controls: Inform appropriate managerial or supervisory personnel of all environmental 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. Very high sensitivity of a dust cloud to ignition, based on
minimum ignition energy. Keep away from heat, sparks, flame and all other sources of ignition.
Strong dust explosion characteristic. Avoid conditions which create dust. Protect from sunlight.

Incompatible materials Strong oxidising agents.

Hazardous decomposition products: Irritating and/or toxic fumes and gases may be emitted upon the product's decomposition.

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 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.