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Administrative data

Description of key information

In a 28-day oral gavage study reduced body weights were noted in high dose male rats at 500 mg/kg bw/d which proved to be reversible upon 14-day recovery. The NOAEL was 150 mg/kg bw/d.
In a read across approach subchronic 6-month inhalation studies with rats, guinea pigs and rabbits were considered. A NOAEC of 300 ppm (13.4 mmol/m³) was identified based on reduced body weight at 600 ppm (26.7 mmol/m³) in male rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
1 500 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

NOAEL (oral, rat) : subacute 28 -day gavage study in rats based on reduced body weight at 500 mg/kg bw/d

NOAEL (dermal, rat) calculated from 28 -day oral study, assuming a worst case of 100% dermal absorption

NOAEC (inhalation, rat) calculated from read across to 6-month repeated dose inhalation study with cyclohexene (NOAEC 300 ppm =13.4 mmol/m³) based on reduced body weight gain at 600 ppm

Justification for classification or non-classification

Based on the results in experimental studies upon repeated dosing, no classification according to EU and GHS criteria is required.