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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.