Registration Dossier

Administrative data

First-aid measures

Description of First Aid Measures
Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Most Important Symptoms and Effects, Both Acute and Delayed
Symptoms and Effects of Exposure: No data available
Medical Conditions Aggravated by Exposure: None known

Indication of the Immediate Medical Attention and Special Treatment Needed
Notes to Physician: None

Fire-fighting measures

Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.

Special Hazards Arising from the Substance or Mixture
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire. May include oxides of carbon and nitrogen.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions. Dust can form an explosive mixture in air.

Advice for Fire-Fighters
During all firefighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

Accidental release measures

Personal Precautions, Protective Equipment and Emergency Procedures
Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental Precautions
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning Up
Measures for Cleaning /Collecting:
Remove all sources of ignition. Contain the source of the spill if it is safe to do so. Collect spilled material by a method that controls dust generation. Avoid use of a filtered vacuum to clean spills of dry solids. Clean spill area thoroughly.

Additional Consideration forLarge Spills:
Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Cleanup operations should only be undertaken by trained personnel.

Handling and storage

Precautions for Safe Handling
Ground and bond all bulk transfer equipment. Avoid open handling. Minimize dust generation. Use local exhaust ventilation or perform work under fume hood/fume cupboard. Avoid inhalation and contact with skin, eye, and clothing. When handling, use appropriate personal protective equipment . Wash hands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls.

Conditions for Safe Storage, Including any Incompatibilities
Storage Conditions: Store at room temperature in properly labeled containers. Keep away from heat, sparks and flames.
Specific end use(s): Pharmaceutical process intermediate

Transport information

Land transport (ADR/RID)

UN number:
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations
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Marine transport (IMDG)

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Exposure controls / personal protection

Control Parameters
The purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categories when the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL). The OEB given is based upon an analysis of all currently available data; as such, this value may be subject to revision when new information becomes available.

Pfizer Occupational Exposure Band (OEB): OEB 3 - Contact Hazards Unknown (control exposure to the range of 10ug/m3 to < 100ug/m3)

Exposure Controls
Engineering Controls: Engineering controls should be used as the primary means to control exposures. Use process containment, local exhaust ventilation, or other engineering controls to maintain airborne levels within the OEB range.

Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Contact your safety and health professional or safety equipment supplier for assistance in selecting the correct protective clothing/equipment based on an assessment of the workplace conditions, other chemicals used or present in the workplace and specific operational processes.

Hands: Wear 2 layers of impervious disposable gloves (e.g. Nitrile, etc.) to prevent skin contact. (Protective gloves must meet the standards in accordance with EN374, ASTM F1001 or international equivalent.)

Eyes: Wear safety goggles as minimum protection. (Eye protection must meet the standards in accordance with EN166, ANSI Z87.1 or international equivalent.)

Skin: Wear impervious protective clothing to prevent skin contact – consider use of disposable clothing where appropriate. (Protective clothing must meet the standards in accordance with EN13982, ANSI 103 or international equivalent.)

Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Band (OEB) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEB (e.g. particulate respirator with a full mask, P3 filter). (Respirators must meet the standards in accordance with EN136, EN143, ASTM F2704-10 or international equivalent.)

Stability and reactivity

Reactivity: No data available

Chemical Stability: Stable under normal conditions of use.

Possibility of Hazardous Reactions
Oxidizing Properties: No data available

Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions. As a precautionary measure, keep away from heat sources and electrostatic discharge.

Incompatible Materials: As a precautionary measure, keep away from strong oxidizers

Hazardous Decomposition Products: No data available

Disposal considerations

Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. 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.