Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In addition to the technical issues for a OECD 422/421 study, an assessment of the available data on the substance was also considered.
The study does not need to be conducted if the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or the substance is a known germ cell mutagen and appropriate risk management measures are implemented.
The substance is currently classified as Carc. Cat 2 (H351: Suspected of causing cancer) and was mutagenic in in-vitro gene mutation studies, although the genotoxicity data is inconclusive for classification. The substance has also been identified as a possible alkylating agent.
Therefore, although the substance is not confirmed to be a genotoxic carcinogen or germ cell mutagen, there is known hazards for both carcinogenicity and mutagenicity. Appropriate risk management measures are implemented during use to ensure safety to workers. Therefore, a reproductive toxicity study is considered unnecessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion