Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Nopyl acetate was tested in a reverse gene mutation assay in bacteria, performed according to OECD guideline 471 and in compliance with GLP, in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102), either with or without metabolic activation, up to a limiting plate incorporation of 5000 micrograms/plate or up to cytotoxic concentrations. The results were negative.

Nopyl acetate was also tested, in presence and in absence of metabolic activation, in a chromosome aberration test performed in cultured human lymphocytes according to OECD guideline 473 and in compliance with GLP. The substance did not increase the rate of chromosomal aberrations except under the test condition 20h exposure without S9. This result was judged equivocal and nopyl acetate was reinvestigated in an in vitro micronucleus test under the same experimental conditions (20h exposure without S9) in the same test system (cultured human lymphocytes). The result was clearly negative.

The results of a gene mutation test (HPRT) in CHO cells were also negative. Nopyl acetate was tested with and without metabolic activation. The study was performed according to OECD guideline 476 and in compliance with GLP.

There is no requirement to conduct additional genotoxicity tests with nopyl acetate, as negative results were obtained in appropriate test systems.


Justification for selection of genetic toxicity endpoint
Several studies in vitro were used to complete this endpoint: Ames, chromosome aberration, micronucleus and HPRT tests.

Short description of key information:
Negative results were obtained with nopyl acetate in two in vitro mutagenicity tests (Ames test and HPRT test). The results of a chromosome aberration test were also negative except for the test condition 20h exposure without S9. However, the toxicological significance of this observation was considered questionable and the substance was reinvestigated immediately in an in vitro micronucleus test performed under the same experimental conditions (20h exposure without S9) and with the same test system (cultured human lymphocytes). The result was then clearly negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of the in vitro tests performed with nopyl acetate (mutagenicity in bacteria, mutagenicity in mammlian cells and clastogenicity tests) were negative. Based on these studies, nopyl acetate is not expected to induce heritable mutations in germ cells and is therefore not classified for mutagenicity/genotoxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.