Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
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Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Manufacture name:
Manufacturing process of the substance
Related composition(s):
Composition 7
Name of activity / technique:
Manufacture of the substance
Environmental release category (ERC):
ERC1: Manufacture of the substance
Name of activity / technique:
Manufacture of the substance
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 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
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
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Formulation, re-packing, storage and distribution of the substance
Related composition:
Composition 7
Name of activity / technique:
Formulation, re-packing, storage and distribution
Environmental release category (ERC):
ERC2: Formulation into mixture
ERC3: Formulation into solid matrix
Name of activity / technique:
Formulation into friction materials
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
PROC 5: Mixing or blending in batch processes
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 15: Use as laboratory reagent
Product category formulated:
PC 0: Other: Friction material manufacture, wear-resistant material in disc-pads, brake-linings and clutch
Substance supplied to that use in form of:
as such
in a mixture
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Cold press moulding process of the dry mixtures
Related composition:
Composition 7
Name of activity / technique:
Cold press moulding process of the dry mixtures
Environmental release category (ERC):
ERC2: Formulation into mixture
ERC3: Formulation into solid matrix
Name of activity / technique:
Cold press moulding process of the dry mixtures
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Product category formulated:
PC 0: Other: wear-resistant material in disc-pads, brake-linings and clutch
Substance supplied to that use in form of:
in a mixture
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Manufacture of automotive brakes parts
Regulatory status:
other: use of the substance in mixture above the concentration limit specified in REACH art. 14
Related composition:
Composition 7
Name of activity / technique:
Manufacture of automotive brakes parts
Environmental release category (ERC):
ERC5: Use at industrial site leading to inclusion into/onto article
Name of activity / technique:
Manufacture of automotive brakes parts
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Process category (PROC):
PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category used:
PC 0: Other: automotive components
Sector of end use:
SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment
SU 0: Other: automotive
Substance supplied to that use in form of:
as such
in a mixture
Subsequent service life relevant for this use:
yes
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Production of final articles from the pre-formed mixtures
Regulatory status:
other: use of the substance in mixture above the concentration limit specified in REACH art. 14
Related composition:
Composition 7
Name of activity / technique:
Production of final articles from the pre-formed mixtures
Environmental release category (ERC):
ERC5: Use at industrial site leading to inclusion into/onto article
Name of activity / technique:
Production of final articles from the pre-formed mixtures
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 14: Tabletting, compression, extrusion, pelletisation, granulation
PROC 24: High (mechanical) energy work-up of substances bound in materials and/or articles
Product category used:
PC 0: Other: (non intended to be released): wear resistant articles used in manufacturer of automatives
Sector of end use:
SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant for this use:
yes
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Industrial use of article in automotive industry
Related composition:
Composition 7
Environmental release category (ERC):
ERC4: Use of non-reactive processing aid at industrial site (no inclusion into or onto article)
Process category (PROC):
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category used:
PC 0: Other: automotive components
Sector of end use:
SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant for this use:
yes
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Professional use of articles in automotive industry
Regulatory status:
other: use of the substance in mixture above the concentration limit specified in REACH art. 14
Related composition:
Composition 7
Name of activity / technique:
Professional use of article in automotive industry
Environmental release category (ERC):
ERC8a: Widespread use of non-reactive processing aid (no inclusion into or onto article, indoor)
ERC8d: Widespread use of non-reactive processing aid (no inclusion into or onto article, outdoor)
Name of activity / technique:
Professional use of article in automotive industry
Process category (PROC):
PROC 21: Low energy manipulation of substances bound in materials and/or articles
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category used:
PC 0: Other: automotive maintenance/manufacturer, automotive components
Sector of end use:
SU 17: General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment
SU 0: Other: garages
Substance supplied to that use in form of:
in a mixture
Subsequent service life relevant to this use:
yes
Related assessment:
use assessed in a joint CSR
Reason / purpose:
exposure-related information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Use of final products by the general population
Regulatory status:
other: use of the substance in mixture above the concentration limit specified in REACH art. 14
Related composition:
Composition 7
Name of activity / technique:
Use of final product by the general population
Environmental release category (ERC):
ERC8d: Widespread use of non-reactive processing aid (no inclusion into or onto article, outdoor)
Environmental release category (ERC):
ERC8f: Widespread use leading to inclusion into/onto article (outdoor)
Name of activity / technique:
Use of final product by the general population
Product category (PC):
PC 0: Other: automotive maintenance/manufacturer, automotive components
Substance supplied to this use in the form of:
in a mixture
Subsequent service life relevant to this use:
yes
Related assessment:
use assessed in a joint CSR

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion