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Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro, the following studies are available:

1) An Ames assay was conducted under OECD 471 using Salmonella tester strains (Jones, 1989). Key study.

It is concluded that no evidence of mutagenic potential of the test substance was obtained in this bacterial test system at the dose levels used.

2) Another Ames assay was conducted using Salmonella tester strains (Lavelle, 1986). Supporting study.

3) A GLP-compliant mouse lymphoma assay performed by SITEK Research Laboratories with N-Octylpyrrolidone is available, which can be used to address this endpoint for N-(n-dodecyl) pyrrolidinone. As pointed out in chapter 4 of the Read-Across-justification report, these two molecules show analogue alerts with respect to DNA and protein binding potency. Further, both molecules proved to be negative for mutagenicity in the Ames test. Consequently, this justifies the use of the Mouse lymphoma assay performed with N-(n-octyl)- 2-pyrrolidinone for addressing this endpoint for N-(n-dodecyl)pyrrolidinone.

Under conditions of this study, the test substance was found to be nonmutagenic in either with or without S-9 metabolic activation.

4) Cytogenetic assay in-vitro study: waived based upon REACH Annex VIII Section 8.4.2 column 2 on grounds that adequate data from a reliable in vivo mutagenicity study are available which shows a clear negative result.


Short description of key information:
Negative based on the following studies:
1) An Ames assay was conducted under OECD 471 using Salmonella tester strains (Jones, 1989). Key study.
2) Another Ames assay was conducted using Salmonella tester strains (Lavelle, 1986). Supporting study.
3) A GLP-compliant mouse lymphoma assay performed with N-Octylpyrrolidone is available, which can be used to address this endpoint for N-(n-dodecyl) pyrrolidinone.
4) Cytogenetic assay in-vitro study: waived based upon REACH Annex VIII Section 8.4.2 column 2 on grounds that adequate data from a reliable in vivo mutagenicity study are available which shows a clear negative result.
5) Genetic toxicity in vivo: A mouse micronucleus test which is key study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Genetic toxicity: Both in-vitro Ames and mouse lymphoma test and in-vivo mouse micronucleus test give negative results.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.5.1 the substance is not classified for genetic toxicity endpoint.