Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
52.5 mg/kg bw/day
Study duration:

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.