Registration Dossier

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
A study equivalent/similar to OECD 414 (Prenatal Developmental Toxicity Study; Palmer et al. 1974) was performed on a substance utilised in this dossier for Read-Across purposes (sodium dodecyl sulphate), therefore negating the need to commisssion an additional toxicity to reproduction study. As per Regulation (EC) 1907/2006, Annex VII, Part 8.7.1, Column 2 - the study/ies do(es) not generally need to be conducted if:
a pre-natal developmental toxicity study (Annex IX, 8.7.2: Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure - B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414) is available.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion