1-Pyrrolidinecarboxylic acid, 2-[5-[4'-[2-[(2S)-1-[(1,1-dimethylethoxy)carbonyl]-2-pyrrolidinyl]-1H-imidazol-5-yl][1,1'-biphenyl]-4-yl]-1H-pyrazol-3-yl]-, 1,1-dimethylethyl ester, (2S)-

Guidance on Safe Use

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.If skin irritationpersists, call a physician.  

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

Ingestion Obtain medical attention.  Do NOT induce vomiting.  Never give anything by mouth to  an unconscious person.  

Notes to Physician Material not fully tested.  Pregnant or nursing women should avoid  exposure.  

Medical Surveillance Employees who are pregnant, are breast-feeding, or who are concerned with other  reproductive issues should be encouraged toconsult with the occupational health physician monitoring worker's health.  

Other information Precautionary risk management may be different from the exposure categories in the annex.

Fire-fighting measures

Flammable Properties Not available

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

self-contained breathing apparatus.  

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

Other information 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, lab coat and impervious gloves.  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 withsuitable material.  

Cleanup Methods  Contain and collect spillage and place in container for disposal according to local  regulations.   Use a HEPA vacuum or moisten     materials to minimize dust generation during pick-up.  Clean area with detergent and water after spill pick-up,if appropriate.  Handle waste materials , including gloves, protective clothing, contaminated spill cleanup material, etc., as appropriate for chemically and pharmacologically similar materials.

     

Handling and storage

Handling Precautions  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.  Store over dessicant material.  Do not store near  incompatible substances.  Protect against light.       Keep away from heat, sparks and flames.  

Transport information

Shipping

SpecialProvisions

Shipping

Remarks

Marine transport (UN RTDG/IMDG)

Shipping

Remarks

Shipping

Remarks

SpecialProvisions

Exposure controls / personal protection

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 15 milligrams, a standard laboratory with general laboratory dilution ventilation (e.g. 6-12 air changes per hour) is

appropriate.  When handling quantities from 15 milligrams to 1 kilogram, work in a standard laboratory using a fume hood, biological safety

cabinet(Class II, all types), or approved vented enclosure.  Quantities exceeding 1 kilogram should be handled in a designated laboratory.  A

laminar flow/powder containment booth is recommended for handling >1 kilograms of active substance.  For manufacturing and pilot plant

operations, use direct coupling and closed transfer systems for all bulk transfers. Use dust tight valves as appropriate.  HEPA filtration of local

exhaust ventilation (LEV) is required.  

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 respiratorwith 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 (E136) when exposures are 25-50 times the exposure control guideline.  

Wear a tight-fitting, full facepiece HEPA PAPR (EN 12942) when exposures are 50-100 times the exposure control guideline.   Wear a hooshroud HEPA PAPR (EN 12941) or full facepiece supplied air respirato(EN 139) operated in a pressure demand or other positive pressure modewhen 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 splashpotential exists or if corrosive materials are present.   Note: Choice of eyeprotection may be influenced by the type of respirator which is selected.  

Hand protection Impervious nitrile, rubber and latex gloves are recommended (EN 420, EN374).   If material is handled in solution, the solvent should also be considered when selecting protective clothing material.  Please note that employees who are allergic to natural rubber latex should use nitrile

gloves.  

Skin and body protection Wear a laboratory coat (EN 340) when handling quantities up to 1 kilogram.  For quantities over 1 kilogram, wear laboratory coat(EN 340)or coverall of low permeability (EN 1149-1).  For manufacturing operations, wear coverall of low permeability (EN 465/1149-1).        For manufacturing operations, wear coverall of low permeability (EN 1149-1).

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

Chemical Stability  Stable under normal conditions.  Material is light sensitive.  

Conditions to avoid  : light  

 

Materials to avoid|:  strong acids  

Hazardous decomposition  products

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

Hazardous reactions None known.      

Sensitivity to static discharge/Dust exp.  

Summary Statements Although material has not been specifically tested, fine dust suspended in air in sufficient concentration and in the presence of an ignition source may pose a potential explosion hazard.  Provide appropriate bonding and grounding protection to control static charge.     Powder handling equipment such as dust collectors, dryers, and mills may require additional protective measures (e.g. explosion venting, inerting, etc.).  

Disposal considerations

Advice On Disposal And Packaging:  Disposal should be in accordance with applicable regional, national and  local laws and regulation

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.