Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, information requirement 8.7.1 (a screening study for reproductive/ developmental toxicity) does not need to be conducted as a pre-natal developmental toxicity study is available on the substance (as required under REACH Annex IX, 8.7.2).
In addition, the substance is considered to be carcinogenic, mutagenic and toxic to reproduction (category 1B) and the appropriate risk management measures are implemented.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion