Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

First-aid measures

Inhalation: Move to fresh air. Call a physician if symptoms develop or persist. For breathing difficulties,
oxygen may be necessary.
Skin contact: Remove contaminated clothing. Wash off with soap and plenty of 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 c
onsult a physician.
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.

Fire-fighting measures

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:
High concentration of airborne dust may form explosive mixture with air. 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 contain
ers from fire area if you can do so without risk.

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:
Wear appropriate protective equipment and clothing during clean-up. Keep unnecessary personnel
away. Keep people away from and upwind of spill/leak. Ensure adequate ventilation. Avoid inhalation
of dust from the spilled material. Ventilate the contaminated area. Avoid contact with eyes, skin, and
clothing. Do not touch damaged containers or spilled material unless wearing appropriate protective
clothing.
Environmental precautions: 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. Avoid the generation of du
sts during clean-up. Avoid release to the environment.
Large Spills: Stop the flow of material, if this is without risk. Absorb in vermiculite, dry sand or earth
and place into containers. Clean surface thoroughly to remove residual contamination.
Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove
residual contamination.
Never return spills to original containers for re-use.

Handling and storage

Precautions for safe handling:
Minimise dust generation and accumulation. Routine housekeeping should be instituted to ensure that
dusts do not accumulate on surfaces. Dry powders can build static electricity charges when subjecte
d to the friction of transfer and mixing operations. Provide adequate precautions, such as electrical
grounding and bonding, or inert atmospheres. Do not handle, store or open near an open flame, sour
ces of heat or sources of ignition. Protect material from direct sunlight. Avoid breathing dust. Provide
appropriate exhaust ventilation at places where dust is formed. Wear personal protective equipm
ent. Avoid contact with eyes, skin, and clothing. Do not taste or swallow. Observe good industrial h
ygiene 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, sparks and open flame. Prevent electrostatic charge build-up by using commo
n bonding and grounding techniques.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
Not regulated as dangerous goods.
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Inland waterway transport (UN RTDG/ADN(R))

UN number:
Not regulated as dangerous goods.
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Marine transport (UN RTDG/IMDG)

UN number:
Not regulated as dangerous goods.
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Air transport (UN RTDG/ICAO/IATA)

UN number:
Not regulated as dangerous goods.
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Exposure controls / personal protection

Appropriate engineering controls:
Provide adequate general and local exhaust ventilation. Keep air contamination levels below the
exposure limits or within the OEB range. Use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits or within the OE
B range.


 


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 goggles as minimum protection (additionally, face shield
recommended for open handling).
Skin protection: Wear appropriate chemical resistant gloves. Nitrile gloves are recommended.
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:
In case of insufficient ventilation, wear suitable respiratory equipment. Respiratory protection should
be provided in instances where exposure to dust, mists, aerosols or vapors are likely. If airborne
exposures are within or exceed the Occupational Exposure Band (OEB) range, wear an appropriate
respirator with a protection factor sufficient to control exposures to the bottom of the OEB range.
Chemical respirator with organic vapour cartridge, full facepiece, dust and mist filter. 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.

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. Minimise dust generation and accumulation.
Keep away from heat, sparks and open flame.
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

Avoid release to the environment. Do not allow this material to drain into sewers/water supplies.
Do not discharge into drains, water courses or onto the ground. 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.