Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according OECD TG 422 was performed. 2 -tert-buty-5 -methylphenol was administered to SD(Crj:CD) rats by gavage at doses of 0 (vehicle ; corn oil) 2.5, 12.5 and 60 mg/kg from 14 days before mating to 14 days after mating in males and from 14 days before mating to day 3 of lactation in females. The NOAEL for maternal and pubs toxicity was considered to be 12.5 mg/kg/days
Effect on fertility: via oral route
Dose descriptor:
NOAEL
12.5 mg/kg bw/day
Additional information

6-tert-butyl-m-cresol shall be registrated according REACH Article 18 (transported isolated intermediate) an no studies for reproduction are required according REACH Annex VII. Further testing is not justified on scientific and animal welfare grounds.

However a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according OECD TG was performed. According this study the NOAEL = 12.5 mg/kg/day.


Short description of key information:
no studies available for fertility relating to 6-tert-butyl-m-cresol

Effects on developmental toxicity

Description of key information
no studies available for developmental toxicity/teratogenicity relating to 6-tert-butyl-m-cresol
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
12.5 mg/kg bw/day
Additional information

However a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according OECD TG was performed. According this study the NOAEL = 12.5 mg/kg/day.

Toxicity to reproduction: other studies

Additional information

6-tert-butyl-m-cresol shall be registrated according REACH Article 18 (transported isolated intermediate) an no studies for reproduction are required according REACH Annex VII.

A reproductive toxicity study in rats (OECD TG 422) revealed that this substance was toxic to the dams at 60 mg/kg, causing depression of the body weight gain and a slight decrease in the number of corpora lutea and implantations. This effect in dams influenced the outcome of pregnancy, seen as a decrease in the number of live births and depression of weight gain in the offspring. These effects were not seen at 12.5 mg/kg/day. No evidence of malformations was observed at any dose

The study demonstrates that the NOAEL for reproduction is the same as for the repeated dose (NOAEL = 12.5 mg/kg/day).

No adverse effects on reproduction are expected if the daily dose did not exceed the dose for the NOAEL for the repeated dose toxicity

Justification for classification or non-classification

there is no evidence to cause a suspicion of impaired fertility or developmental toxicity in the absence of signs of marked maternal toxicity.

A classification is therefore not necessary