4-methyl-3-decen-5-ol

Endpoint summary

Additional information

In Vitro bacterial reverse mutation test (Ames).

The key study for this endpoint, Verspeek-Rip (2002), was performed to the standardised guidelines OECD 471and EU Method B.13/14 and in compliance with GLP. The study was performed and reported to a high standard. In accordance with the criteria for assessing data quality as described by Klimisch (1997), the study was assigned a reliability score of 1. The study was performed using both the direct plate and preincubation methods. Salmonella typhimurium strains TA98, TA 100, TA 102, TA 1535 and TA 1537 were exposed to varying concentrations of the test material, on 4-methyl-4-decen-5-ol, in the presence and absence of metabolic activation. Under the conditions of the study, the test material was non-mutagenic in the Salmonella typhimurium reverse mutation assay both in the presence and in the absence of metabolic activation. Under the conditions of the test, the test substance was found to be non-mutagenic in S. typhimurium strains TA100, TA98, TA1535 and TA1537 in both the presence and absence of metabolic activation.

 

Jagannath (1981) was provided as supporting information to the key in vitro genetic mutations study in bacteria data requirement. The study was performed in compliance with GLP following a similar protocol to the one set out in Ames et al (1975), the mutagenicity of the test material (4-methyl-4-decen-5-ol ) was determined in five strains of Salmonella typhimurium.TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were exposed to varying concentrations of the test material in the presence and absence of the metabolic activation. Under the conditions of the test the test material gave a negative response both in the presence and in the absence of metabolic activation and is considered to be non-mutagenic in the bacterial strains of Salmonella typhimurium tested. The study was performed to a high standard, however, the raw data reporting the results was not available. It was therefore not possible to confirm the conclusions of the study based on the available data. Therefore in accordance with the principles for assessing data quality as described in Klimisch (1997), the study was assigned a reliability score of 2.

 

In Vitro mammalian cell gene mutation test

The test material has been assessed by read-across to structural, mechanistically similar substance using the OECD QSAR Toolbox to predict the potential of the target substance to induce gene mutations and structural chromosome aberrations in a mammalian cell line.

 

In Vitro mammalian chromosome aberration test

The test material has been assessed by read-across to structural, mechanistically similar substance using the OECD QSAR Toolbox to predict the potential of the target substance to induce structural aberrations in a cell line.

 

In Vivo mammalian erythrocyte micronucleus test

The test material has been assessed by read-across to structural, mechanistically similar substance using the OECD QSAR Toolbox to predict the potential of the target substance to induce structuraland numerical aberrations.

Justification for classification or non-classification

According to the EU Regulation EC 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for germ cell mutagenicity.