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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Additional information

Study does not need to be conducted according to REACH Annex VIII 8.7.1 because information from teratogenicity studies and repeated dose studies are available. Since significant scientific evidence for a lack of reprotoxic effects of the substance is drawn from these results and an additional two generation study is not expected to add any further relevant knowledge on this endpoint. Due to animal welfare aspects and/or laws, an additional study is therefore not warranted.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
150 mg/kg bw/day
Additional information

NOAEL for maternal toxicity: Administration of 4,6-bis(octylthiomethyl)-o-cresol during gestation by oral gavage at a dose level of 300 mg/kg elicited slight maternal toxicity (slightly reduced body weight gain and - possibly - slightly reduced food consumption), but no embryotoxicity, and no teratogenicity.
Administration of 50 and 150 mg/kg did not elicit any maternal toxicity, embryotoxicity, or teratogenicity

Justification for classification or non-classification

Based on the results there is a significant scientific evidence for a lack of reprotoxic effects of 4,6-bis(octylthiomethyl)-o-cresol and an additional two generation study is not expected to add any further relevant knowledge on this endpoint. Due to animal welfare aspects and/or laws, an additional study is therefore not warranted.

Additional information