Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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