Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
genetic toxicity in vivo, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Three invitro gene mutation studies were conducted:
- the Mammalian Cell Gene Mutation test using the HPRT genes following OECD 476
Three invitro/exvivo gene mutation studies were conducted:
- the Mammalian Cell Gene Mutation test using the HPRT genes following OECD 476
- the Bacterial Reverse Mutation Test / Ames test following OECD 471 and EU B.13/14
- the Mammalian Cell Micronucleus Test following OECD 487 and EU B.49
As two of the three conducted invitro/exvivo tests exhibited clear negative results, and one test, the Mammalian Cell Micronucleus Test, exhibited not a positive, but an ambiginous test, no further invivo testing on gentoxicity is scientifically necessary and responsible with respect to the animal protection provisions.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion