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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
ECHA considers registration dossiers for substances > 100 tpa as technically complete even if they do not contain the results of a screening study for reproductive/developmental toxicity if:
- a 90-day subchronic toxicity study is available
- if the dossier contains either the results of, or a testing proposal for a prenatal developmental toxicity study
As a subchronic 90-day oral toxicity study is already available and a developmental/teratogenicity is planned to be conducted, the reprotoxicity screening study is waived.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion