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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Emergency measure - Inhalation: Remove the person from exposed area to fresh area

immediately. Get medical advice following prolonged exposure

.

Emergency measure - Eyes: Wash immediately with large amounts of water or normal

saline; keep the eyelid open with the finger. Get medical

advise if symptoms appear.

Emergency measure - Skin: Remove contaminated clothes and shoes immediately. Wash

affected area with soap or mild detergent and large amount

of water until no evidence of chemical remains (15-20

minutes). Get medical attention if symptoms appear.

Emergency measure - Ingestion: If swallowed wash out mouth with water provided person is

conscious. Do not induce vomiting. Treat symptomatically and

supportively. Get medical advice if symptoms appear.

Fire-fighting measures

Recommended extinguishing agent: Dry chemical, carbon dioxide, water spray or regular foam

Product arising from burning: Thermal decomposition or combustion may include toxic and

hazardous fumes.

Product determined by test: N

Protective equipment: Safety Shoes/Boots for Schwarz Pharma Employees:

All safety Shoes/Boots used on site must as a minimum have

antistatic properties, conform to EN 345 S1 and be CE

Marked. Personnel working in production, warehouse and

maintenance areas must wear safety boots. This is to provide

the wearer with extra ankle support. Personnel in other

areas have a choice between safety shoes and safety boots.

Safety Shoes/Boots for Contractors:

All safety Shoes/Boots used on site must as a minimum have

antistatic properties, conform to EN 345 S3 and be CE

Marked. Contractors working at Schwarz Pharma Limited must

provide their own safety boots.

Safety Shoes/Boots for Visitors:

All safety Shoes/Boots used on site must as a minimum have

antistatic properties, conform to EN 345 S1 and be CE

Marked. Visitors on site will be provided with Safety shoes

at reception and should be returned to reception after use.

These shoes are then sanitised with a shoe sanitiser before

being returned to storage.

Safety Wellingtons:

All Safety Wellingtons used on site must as a minimum, have

antistatic properties, conform to EN 345 S1 and be CE

marked.

Hearing Protection:

Two forms of hearing protection are available to Schwarz

Pharma personnel working on site. Helmet mounted ear muffs

or Ear plugs. Both of which must conform to EN 352. Hearing

protection must provide sufficient attenuation to bring

Noise exposure to below 80  dB(A).

Safety helmets:

Helmets must be worn by all personnel beyond the red line

area including contractors and visitors. All helmets must be

CE marked and must conform to EN397 1995. All Schwarz

Pharma Limited employees will have their Helmets changed

every two years or sooner if they have been damaged.

Hi Viz Traffic Jackets or Hi Viz Vests:

Must be worn by all contractors on site. Schwarx Pharma

personnel not involved  with routine chemical handling will

also be provided with Hi Viz Traffic Jackets or Hi Viz

Vests. All Hi Viz clothing must be CE marked and conform to

EN 471.

Gas masks:

All full face gas masks must be CE marked and conform to EN

136.

Safety glasses:

General safety glasses must be CE marked and conform to EN

166. These glasses should be at lease impact resistant to

level 1F of the standard. Safety Over glasses must be CE

marked and conform to EN 166.  These glasses should be at

lease impact resistant to level 1F of the standard.

Disposable white overalls:

Such overalls must be CE marked  and should be Antistatic to

conform to EN1149. These suits  should have limited Splash

protection against chemicals to a minimum Type 6.

Breathing Air Hoses:

Must conform to EN270 or EN 139 Air Hoods must conform to EN

270 and EN 464.

Air Suits must conform to EN 943 part 1. Couplings for same

must conform to EN 270.

Gloves must conform to EN388, EN374 and EN 1149 part -1 and

-2.

Accidental release measures

Emergency measures in case of spillage: Sweep up and place into a suitable container for disposal in

compliance with the national laws.

Dress standard PPE (Personal Protection Equipment) EN

standards for PPE are as follows: EN136 respirator fitted

with and A2B2E2K2-P3 cartridge, gloves used are EN grade 10

gloves, safety glasses rated to EN166 and safety shoes rated

to EN345 S1.

Keep away from sources of ignition.

Handling and storage

Handling: Avoid inhalation, contact and ingestion. When use do not

eat, drink or smoke.

In all working places provide sufficient ventilation.

EN standards for PPE are as follows: EN136 respirator fitted

with an A2B2E2K2-P3 cartridge, gloves used are EN grade 10

gloves, safety glasses rated to EN166 and safety shoes rated

to EN345 S1.

Engeneering controls are as follows:

Local Exhaust Ventilation System in BPC comprises of a

single fan extraction system which discharges into the main

EPA licensed Emission point for the BCP building. The LEV

system is active on both the ground floor and the first

floor of the building. From the fan a number of main headers

are tied in. At the point of use a four inch PVC duct stems

from the main header which is then connected to a six inch

neederman head unit which provides flexibility of use to the

operator. The minimum face velocity required form each

point is 0.5 m/s.

The fire alarm system in the BCP plant is an L1/M Analogue

Addressable Fire Alarm System. This comprises of IP and I.S.

Heat detector heads in the production areas and IP and I.S.

rated Smoke detectors in the non process areas. All exits

have a break glass unit just inside them and there are break

glass units within 30 m of any operator.

The Fire Sprinkler system in the building is fed from the

main water supply to the site. Again all areas of the

building have sprinkler head protection suitably located

which are inspected by the insurance people on at least an

annual basis. Integrated into the sprinkler system is a foam

tank which draws foam into and mixes with water to provide

further protection.

Storage: Store in cold, dry and dark places; keep container tightly

closed when not in use.

Packaging of the substance and or preparation: The substance is transported in 25 kg HDPE drums.

Transport information

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Remarksopen allclose all

Marine transport (UN RTDG/IMDG)

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Air transport (UN RTDG/ICAO/IATA)

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Special provisions / remarks
Remarks:
Transport: not regulated
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Exposure controls / personal protection

Stability and reactivity

Danger other than fire: not known

Chemical reaction with water: Not hazardous (see related Chilworth study no. J13564)

Dust explosion: Not known

Dust explosion determined by test: N

Disposal considerations

Industry - Possibility of recovery/recycling: Recovery offsite

Industry - Possibility of neutralisation: none

Industry - Possibility of destruction - incineration: Recommended

Industry - Possibility of destruction - water purification: Not applicable

Industry - Possibility of destruction - other: Not known

Public at large - Possibility of recovery/recycling: Not applicable

Public at large - Possibility of neutralisation: Not applicable

Public at large - Possibility of destruction: controlled discharge: Not applicable

Public at large - Possibility of destruction - incineration: Not applicable

Public at large - Possibility of destruction - water purification: Not applicable

Public at large - Possibility of destruction - others: Not known