[No public or meaningful name is available]

Endpoint summary

Additional information

 Genetic toxicity (mutagenicity) in bacteria in vitro

A bacterial gene mutation assay (Ames test) was performed with Amides, C18, branched and linear according to OECD TG 471 (Bowles, 2003). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested in two repetitions (triplicates each) at concentrations from 0.15 to 5000 µg/mL (vehicle: DMSO) in the preliminary toxicity test, and at concentrations from 50 to 5000 µg/mL (-/+ S9) (vehicle: DMSO) in the mutation test. No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. Cytotoxicity was observed in a preliminary toxicity test at concentrations at 5000 µg/plate. Thus, 5000 µg/plate was the highest concentration used in this test with and without metabolic activation. The included positive and negative/vehicle controls showed the expected results. Under the conditions of the study, the test substance did not induce mutations in the bacterial gene mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.

 

Genetic toxicity (chromosome aberration) in human lymphocytes in vitro

An in vitro chromosome aberration test in human lymphocytes was performed with Amides, C18, branched and linear according to OECD TG 473 (Wright, 2003). Human lymphocytes of fresh heparinized whole blood from peripheral circulation of a volunteer were tested in two repetitions at concentrations from 19.53 to 5000 µg/mL (vehicle: DMSO) in the preliminary toxicity test, at concentrations from 9.77 to 312.5 µg/mL (-/+ S9) (vehicle: DMSO) and at concentrations from 9.77 to 312.5 µg/mL (- S9) and 4.88 to 78.13 µg/mL (+ S9) in the aberration test. No significant increase in the number of polyploid and aberrant cells was noted in any of the tested concentrations with and without metabolic activation system. Cytotoxicity was observed in the first experiment at concentrations at 78.13 µg/mL (- S9) and 156.25 µg/mL (+ S9) and in the second experiment at concentrations at 19.53 µg/mL (- S9) and 39.06 µg/mL (+ S9). Precipitation of the test material was observed at a concentration of 156.25 µg/mL. Under the conditions of the study, the test substance did not induce polyploid and aberrant cells in the chromosome aberration test in human lymphocytes in absence and presence of a metabolic activation system.

 

Genetic toxicity (mammalian erythrocyte micronucleus assay) in vivo

An in vivo mammalian erythrocyte micronucleus assay was performed with Amides, C18, branched and linear according to OECD TG 474 and in compliance with GLP (Flanders, 2014).The test material was administered via single intraperitoneal application to 7 male Albino mice of each dose group at nominal concentrations of 100, 200, and 400 mg/kg bw. Bone marrow cells of mice from each dose level were freshly isolated 24 hours post-application. In addition, a second group dosed with the test item at 400 mg/kg bw was killed 48 hours post-application. The ratio of polychromatic erythrocytes (PCE) and normochromatic erythrocytes (NCE) was determined by counting and differentiating isolated and fixed erythrocytes. Appropriate negative (7 males, arachis oil) and positive controls (5 males, 50 mg/kg bw cyclophosphamide) were included in the study and showed the expected result. No statistically significant increase in the frequency of micronucleated polychromatic erythrocytes was observed in the 48 or 24-hour 400 mg/kg bw test item dose groups, or the 24-hour 200 mg/kg bw dose group. A very modest, but statistically significant, increase was observed in the 24-hour 100 mg/kg bw test item dose group when compared to the vehicle control group. However, this finding was considered to be artefactual and of no toxicological significance. Based on the results of the study the test substance is negative for the induction of micronuclei under the conditions of the test.

Justification for selection of genetic toxicity endpoint
No study was selected, since the available studies address different relevant types of genetic toxicity, and all available in vitro and in vivo genetic toxicity studies were negative.

Short description of key information:
In vitro genotoxicity:
Bacterial reverse mutation assay (Ames test / OECD guideline 471): negative
In vitro chromosome aberration test in human lymphocytes (CA / OECD guideline 473): negative

In vivo genotoxicity:
Micronucleus assay (OECD guideline 474): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data on genetic toxicity of Amides, C18, branched and linear do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC and are therefore conclusive but not sufficient for classification.