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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