Registration Dossier

Administrative data

Description of key information

5 male and 5 female rats per group were fed 1000, 10000 ppm thymol in the diet (= ca. 67, 667 mg/kg bw/day)  for 19 weeks. Additional a combined repeat dose and reproductive/developmental toxicity screening test at doses of 0 (vehicle), 8, 40, 200 mg/kg day is available. No repeated dose studies are available for dermal and inhalation toxicity.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
667 mg/kg bw/day
Study duration:

Additional information

In the repeated dose feeding study for 19 weeks no effects (indicates that there was no effect on growth or hematology, and no macroscopic or microscopic change is the tissue) at tghe highest applied dose (10.000 ppm = 667 mg/kg bw/d) were seen.

The gavage study (combined Repeat dose and Reproductive/Developmental toxicity screening test) revealed local effects with 40 mg/kg bw/d on the forestomach due to the corrosive properties of thymol which were not seen in the 19 weeks oral feed study, where the test substance is incorporated in the feed matrix.

Therefore for systemic effects the oral feed study was used and for local effects the gavage study, respectively.

Justification for classification or non-classification

Based on the result of the oral repeated dose studies a classification is not justified