Registration Dossier

Administrative data

Description of key information

Treatment of male rats with Bourgeonal was associated with marked systemic toxicity at 250 and 100 mg/kg/day 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Treatment of male rats with Bourgeonal was associated with marked systemic toxicity at 250 and 100 mg/kg/day and, testicular/epididymal toxicity at 100 mg/kg/day. The known metabolite, 4-tert-butylbenzoic acid (TBBA) of the parent substance, which may be associated with testicular toxicity, was found in the urine of males treated at 100 or 25 mg/kg/day.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Treatment of male rats with Bourgeonal was associated with marked systemic toxicity at 250 and 100 mg/kg/day and, testicular/epididymal toxicity at 100 mg/kg/day. The known metabolite, 4-tert-butylbenzoic acid (TBBA) of the parent substance, which may be associated with testicular toxicity, was found in the urine of males treated at 100 or 25 mg/kg/day.
In a read across substance the no-observable effect level to rats of both sexes for a period of at least 4 weeks was observed to be 60 mg/kg/d.

Justification for classification or non-classification

effects observed apply to effects on firtility and as such are addressed in section 7.8