Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: see attached SCCP study report
GLP compliance:
no
Species:
mouse
Strain:
Swiss
Sex:
female
Route of administration:
dermal
Vehicle:
acetone
Duration of treatment / exposure:
108 weeks
Frequency of treatment:
2 applications weekly
Remarks:
Doses / Concentrations:
1, 5 and 10% in acetone
Basis:

No. of animals per sex per dose:
50
Dose descriptor:
T25
Effect level:
> 10 other: percent
Based on:
test mat.
Sex:
female
Remarks on result:
not determinable
Remarks:
no T25 identified. Effect type:carcinogenicity (migrated information)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
T25
Study duration:
chronic
Species:
mouse

Additional information

Justification for classification or non-classification

Based on the available study the substance is not to be classified under REACH and CLP as carcinogenic