12-aminododecanoic acid

Endpoint summary

Additional information

In Vitro Genetic Mutation Study in Bacteria

In the key study, the potential of the test material to produce genotoxic effects was investigated in accordance with the standardised guideline OECD 471. The study was performed in line with GLP and accepted standardised guidelines with a high standard of reporting. The study was assigned a reliability score of 1 according to the principles for assessing data quality set out in Klimisch (1997) and is considered suitable for assessment as an accurate reflection of the test material.

The test material did not show mutagenic activity in Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 either in the absence or in the presence of metabolic activation, under the conditions employed in this evaluation.

 

Supporting information is provided in the form of a second bacterial assay.

The study is only briefly reported but is conducted to sound scientific principles. It was not conducted to a specific guideline; however it bears similarity to OECD 471. Mention is made of the basic methodology of the study but the report lacks precise details of both the procedure followed and the reporting of the results. In accordance with the criteria of Klimisch (1997) it was judged that the appropriate reliability score was 2.

The test material was judged negative for the potential of mutagenicity in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2.

 

In Vitro Gene Mutation Study in Mammalian Cells

The key study was conducted in accordance with OECD 473 to assess the potential of the test material to cause chromosome aberrations in cultured CHO cells in the presence and absence of metabolic activation.

It was performed to GLP and in line with an accepted standardised guideline with a high standard of reporting. The study was assigned a reliability score of 1 according to the principles for assessing data quality set out in Klimisch (1997) and is considered suitable for assessment as an accurate reflection of the test material.

The test material is considered non-clastogenic in this system. The test material did not induce a statistically significant increase in the number of cells with structural chromosome aberrations in cultured CHO cells, at any of the concentrations used, under the conditions employed in this examination.

 

In Vitro Mammalian Cell Gene Mutation

The key study was conducted in accordance with OECD 476 to assess the potential of the test material to induce mutations at the HGPRT locus of CHO cells in the presence and absence of metabolic activation.

It was performed to GLP and in line with an accepted standardised guideline with a high standard of reporting. The study was assigned a reliability score of 1 according to the principles for assessing data quality set out in Klimisch (1997) and is considered suitable for assessment as an accurate reflection of the test material.

The test material neither induced a reproducible positive response at any one of the test material concentrations nor a concentration-related increase in mutant frequency.

Justification for selection of genetic toxicity endpoint
No study selected since the variety of studies is necessary to address the genotoxic risk of exposure to the test material (see below discussion).

Short description of key information:
IN VITRO GENETIC MUTATION STUDY IN BACTERIA
Key study: Bacterial reverse mutation in bacteria: Negative (Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 or TA 100 with and without S9 mix).
Supporting study: Bacterial reverse mutation in bacteria: Negative (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 with and without S9 mix)

IN VITRO GENE MUTATION STUDY IN MAMMALIAN CELLS
Key study: In vitro chromosome aberration: Negative (CHO cells with and without S9 mix).

IN VITRO MAMMALIAN CELL GENE MUTATION
Key study; Gene mutation in mammalian cells: Negative (HGPRT locus of CHO cells with and without S9 mix).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for genetic toxicity based on the overall negative response noted in the available in vitro genetic toxicity studies.