Registration Dossier

Administrative data

Description of key information

The oral NOEL and NOAEL are set at 52.5 mg/kg bw/day..

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
52.5 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Three repeated dose toxicity: oral studies are provided by ECHA in the migrated NONS files, and the results are all taken into account in this summary

The worst case result, at 90 days, is seen in Repeated dose toxicity: oral.002. This study gives a NOEL and NOAEL of 52.5 mg/kg bw/day, and this is accepted as the criticial endpoint.

Justification for classification or non-classification

N-(n-octyl)-2 -pyrrolidinone has a NOEL and NOAEL of 52.5 mg/kg. The substance therefore does not meet the requirements for a classification.