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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye contact:  Rinse immediately with plenty of water for at least 15 minutes. Keep eye wide open while

rinsing. Obtain medical attention.

Skin contact:  Take off contaminated clothing and shoes immediately. Wash off immediately with plenty

of water for at least 15 minutes. Obtain medical attention. Discard contaminated clothing

or wash before re-use.

Inhalation:  Move to fresh air. Oxygen or artificial respiration if needed. Obtain medical attention.

Ingestion:  Do NOT induce vomiting. Consult a physician if necessary. Never give anything by

mouth to an unconscious person.

Notes to Physician: Material not fully tested. .

Medical Surveillance:  Employees who are pregnant, are breast-feeding, or who are concerned with other

reproductive issues should be encouraged to consult with the occupational health physician

monitoring worker's health.

Fire-fighting measures

Flammable Properties:  Not readily combustible

Extinguishing Media: Suitable extinguishing media: Dry chemical, Water spray, Foam

Unsuitable extinguishing media:  Do NOT use water jet.

Protection of Firefighters: Specific hazards: Not available. Protective equipment: Use personal protective equipment. In the event of fire, wear selfcontained breathing apparatus.

Hazardous Combustion Products: carbon oxides (COx), nitrogen oxides (NOx)

Other information:  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. Decontaminate protective clothing and equipment before reuse.

Accidental release measures

Personal precautions: Refer to protective measures listed in sections 7 and 8. Use personal protective equipment. Examples include tightly fitting safety goggles, disposable lab coat of low permeability with cuffs, double gloves and shoe covers. Wear respiratory protection. Depending on the nature of the spill (quantity and extent of spill) additional protective clothing and equipment such as a self-contained breathing apparatus may be needed.

Environmental precautions: Prevent release to drains and waterways. Prevent release to the environment.

Containment Methods Wet down any dust to prevent generation of aerosols, if appropriate. Cover with suitable material.

Cleanup Methods:  Spill prevention procedures and a spill response procedure should be implemented. Contain and collect spillage and place in container for disposal according to local regulations (see Section 13). Clean spill area with a deactivating solution (if available) followed by detergent and water after spill pick-up. Handle waste materials, including gloves, protective clothing, contaminated spill cleanup material, etc., as appropriate for

chemically and pharmacologically similar materials.

Other information Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration. Avoid dispersal of dust in the air (i.e., clearing dust surfaces with compressed air). Nonsparking tools should be used.

Handling and storage

Handling Precautions:  Minimize 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 subjected to the friction of transfer and mixing operations. Provide adequate precautions, such as electrical grounding and bonding, or inert atmospheres. Do not use in areas without adequate ventilation. Avoid exposure - obtain special instructions before use. Avoid formation of dust and aerosols. Keep away from heat and sources of ignition. Prevent release to drains and waterways.

Container Requirements: Store in sturdy containers appropriate to maintain the integrity of this material for its intended use.

Storage Conditions:  Store at room temperature. Protect against light. Keep away from heat, sparks and flames.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
Not listed
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Inland waterway transport (UN RTDG/ADN(R))

UN number:
Not listed
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Marine transport (UN RTDG/IMDG)

UN number:
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Air transport (UN RTDG/ICAO/IATA)

UN number:
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Exposure controls / personal protection

Recommended Industrial Hygiene Monitoring Methods: A specific exposure sampling method is not available. Contact the Bristol-Myers Squibb

AIHA accredited Industrial Hygiene Laboratory at (USA) 732-227-6338. General - The health hazard risk of handling this material is dependent on many factors, including physical form, % API in material being handled, duration and frequency of process task, and effectiveness of controls. If it is necessary to handle this compound outside of engineering controls, an exposure risk assessment should be conducted and procedures documented by a qualified EHS professional.

Engineering Controls and Ventilation:

Use process enclosures, containment technology, or other engineering controls to keep

airborne levels below recommended exposure limit. When handling quantities up to 3

milligrams, a standard laboratory with general laboratory dilution ventilation (e.g. 6-12 air

changes per hour) is appropriate. When handling quantities up to 1 kilogram, work in either a

standard laboratory (<500 g) or designated laboratory (500 g to <1 kg) using a fume hood,

biological safety cabinet(Class II, Type A2 with thimble connection, B1, or B2)or approved

vented enclosure. HEPA filtered exhaust preferred for fume hoods containing particularly

"dusty" operations. Quantities exceeding 1 kilogram should be handled in a designated

laboratory or containment facility using appropriate containment technology. A laminar

flow/powder containment booth or appropriate isolation technology should be considered for

handling more than 1 kilogram of active compound. HEPA filtered exhaust preferred. For

manufacturing and pilot plant operations, barrier/containment technology and direct coupling

(totally enclosed processes that create a barrier between the equipment and the room) with use

of double or split butterfly valves, hybrid unidirectional airflow/local exhaust ventilation

solutions (e.g. powder containment booth) should be used. Glove bags, isolator/glove box

systems are optional. HEPA filtration of exhaust from dry product handling areas is required.

It is recommended that all dust control equipment such as local exhaust ventilation and

material transport systems involved in handling of this product contain explosion relief vents

or an explosion suppression system or an oxygen deficient environment. Ensure that dusthandling

systems (such as exhaust ducts, dust collectors, vessels, and processing equipment)

are designed in an manner to prevent the escape of dust into the work area (i.e., there is no

leakage from the equipment). Use only appropriately classified electrical equipment and

powered industrial trucks.

Respiratory protection

Use and selection of respiratory protection is based upon engineering controls in use and

potential for aerosol generation. When engineering controls are not sufficient control

exposure, wear an approved respirator with NIOSH Class 100 or high efficiency particulate

(HEPA) filters or cartridges (EN 140/EN 136) when exposures are up to 10 times the exposure

control guideline. Wear a loose-fitting (Tyvek or helmet type) HEPA powered-air purifying

respirator (PAPR) (EN 12941) when exposures are 10-25 times the exposure control

guideline. Wear a full facepiece negative pressure respirator with Class 100 or HEPA filters

(EN 136) when exposures are 25-50 times the exposure control guideline. Wear a tightfitting,

full facepiece HEPA PAPR (EN 12942) when exposures are 50-100 times the exposure

control guideline. Wear a hood-shroud HEPA PAPR (EN 12941) or full facepiece supplied

air respirator (EN 139) operated in a pressure demand or other positive pressure mode when

exposures are 100-1000 times the exposure control guideline.

Eye protection Safety glasses with side-shields are recommended (EN 166). Face shields or chemical safety

goggles (EN 166) may be required if splash potential exists or if corrosive materials are

present. Note: Choice of eye protection may be influenced by the type of respirator which is

selected.

Hand protection

Wear gloves at all times when handling containers, including when unpacking, inspecting or

transporting within a facility. Impervious gloves are recommended. (EN 420, EN 374).

Double gloving for all manufacturing personnel potentially in direct contact with the

compound should be considered. If material is handled in solution, the solvent should also be

considered when selecting protective clothing material.

Skin and body protection

Wear a laboratory coat (EN 340) when handling quantities up to 500 grams. For quantities up

to 1 kilogram, wear disposable laboratory coat (EN 340) or coverall of low permeability (EN

1149-1) . For quantities over 1 kilogram and manufacturing operations, wear disposable

coverall of low permeability (EN 1149-1) and disposable shoe covers.

Hygiene Wash hands and face before breaks and immediately after handling the product.

Environmental exposure controls

Prevent release to drains and waterways.

Stability and reactivity

Stability

Chemical Stability: Stable under normal conditions.

Conditions to avoid:  Not available

Materials to avoid: Not available

Hazardous decomposition products: Hazardous decomposition products formed under fire conditions.: carbon oxides (COx), nitrogen oxides (NOx)

Hazardous reactions: Hazardous polymerisation does not occur.

Sensitivity to static discharge/Dust exp.

Explosion Severity Factor: 222 m.b_/s St2 Material exhibits strong explosion characteristics if ignited as a dust cloud.

Minimum Ignition Energy: > 10 - < 25 mJ Material is very susceptible to igniting as a dust cloud under certain conditions due to low minimum ignition energy.

Volume Resistivity (ambient): 170.0000E+12 ohm.m Material is highly susceptible to accumulating static charges during processing.

Charge decay time (ambient): 5.5 H

Ignition temperature: > 490 - < 510 °C

Layer decomposition: No exotherm observed.

Summary Statements

Powder handling equipment such as dust collectors, dryers, and mills may require additional

protective measures (e.g. explosion venting, inerting, etc.). Provide suitable bonding and

grounding for containers, personnel, and process equipment to control static charges. NOTE:

THIS DATA IS REPRESENTATIVE FOR THE SPECIFIC PROCESS STATE OF THE MATERIAL NOTED ON THIS SDS ONLY. Dust explosion severity risk can vary upon processing or environmental change (e.g. milling, micronizing, sieving, blending or heating can increase the risk of explosion), and may require additional dust explosion testing.

Disposal considerations

Advice On Disposal And Packaging

Disposal should be in accordance with applicable regional, national and local laws and regulations. Local regulations may be more stringent than regional or national requirements. This information presented only applies to the material as supplied.

Other information Disposal by incineration is recommended