Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Data waiving:
exposure considerations
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 accordance with column 2 of REACH Annex VIII and IX, the developmental toxicity studies do not need to be conducted since relevant human exposure can be excluded in accordance with Annex XI Section 3.2.a (see IUCLID chapter 13.2 report: Exposure Based Adaptation).

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion