Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicity to reproduction

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Administrative data

screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
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
Justification for type of information:
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 are 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