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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Manufacture, use & exposure

Uses at industrial sites

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Uses at industrial sites

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Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Contributing activity / technique for the environment
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workers
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 4: Chemical production where opportunity for exposure arises
PROC 19: Hand-mixing with intimate contact and only PPE available.
Product category used:
PC 0: Other: Intermediate
Sector of end use:
SU 9: Manufacture of fine chemicals
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
yes

Uses at industrial sites

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Regulatory status:
other: Pharmaceutical
Contributing activity / technique for the environment
Name of activity / technique:
Use of intermediate in the manufacture of API
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workers
Name of activity / technique:
Use of intermediate in the manufacture of API
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
PROC 4: Chemical production where opportunity for exposure arises
PROC 5: Mixing or blending in batch processes
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
PROC 15: Use as laboratory reagent
Product category used:
PC 29: Pharmaceuticals
Sector of end use:
SU 0: Other: Production of pharmaceuticals
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no
Related assessment:
use assessed in a joint CSR

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Product (article) characteristic

Amounts used, frequency and duration of use (or from service life)

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
site specific biological STP
Application of site specific biological STP sludge on agricultural soil:
no

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
dedicated re-collection infrastructure required

Other conditions affecting environmental exposure

Place of use:
indoor

Releases to waste and the environment

Release to external waste

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
solid (unspecified form)

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Conditions and measures related to personal protection, hygiene and health evaluation

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor