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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Read across to structural analogue, EC Name; 6,6’-di-tert-butyl-4,4’-butylidenedi-m-cresol; CAS No. 85 -60 -9, treatment by oral gavage in male and female Wistar Han rats revealed no parental, reproductive, or developmental toxicity up to 1000 mg/kg body weight/day.

Based on these results, a parental, reproductive and developmental No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg/day was derived.


Short description of key information:
Parental, reproductive and developmental No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg/day was derived.

Justification for selection of Effect on fertility via oral route:
Effect level determined in accordance with OECD guideline no. 421.

Justification for classification or non-classification

Based on the results of a close structural analogue the substance does not trigger any of the requirements for classification. The registered susbstance is therefore not classified.

Additional information