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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Additional information

For these endpoints read-across is based on the study of Dr. U. Kaspers performed in 2005 with Wistar Rats exposed to N-Octylpyrrolidone in an extended One-Generation Reproduction Toxicity Study performed under GLP according to the OECD Guideline 415. In addition, a summary is added of the embryotoxicity study performed under GLP with N-Octylpyrrolidone in the rat (Becker et al. 1991).

The reproduction toxicity study (Kaspers, 2005) with analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) was conducted according to OECD Guideline 415 (One-Generation Reproduction Toxicity Study). Key study.

This study showed that general systemic toxicity of the test substance = 1000 mg/kg bodyweight/day in F0 parental males, 100 mg/kg bodyweight/day in F0 parental females; developmental toxicity (growth and development of the F1 offspring until sexual maturity) = 300 mg/kg body weight/day in both genders.

Short description of key information:
A reproduction toxicity study (Kaspers, 2005) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) is available which is key study. This study resulted in a NOAEL for fertility of 1000 mg/kg in both P and F1 generations.

Justification for classification or non-classification

One generation reproductive toxicity study: NOAEL = 1000 mg/kg bw/day.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.7.1 the test substance is not classified for this reproductive toxicity endpoint.

Additional information