3-methyl-5-phenylpentanol

Endpoint summary

Additional information

In vitro gene mutation study in bacteria

The mutagenicity of the test substance was determined in a GLP compliant study performed in accordance to a method similar to the standardised guidelines OECD 471 and EU Method B.13/14. The methodology and the standardised guideline were comparable except, the study was performed before using a strain capable of detecting cross-linking became a standard part of the guideline and was therefore not used as part of the investigation. The study was performed on a structural analogue 3-methyl-5-phenylpentanol, the only difference between the two substances being the position of the methyl group. As such the results are considered to be representative of 3-methyl-5-phenylpentanol and an accurate reflection of its mutagenic potential. The study was performed to a good standard and was assigned a reliability score of 2 in accordance with Klimisch (1997). Under the conditions of the test, the test substance was found to be non-mutagenic.

In vitro clastogenicity in mammalian cells

The clastogenic potential of the test substance was determined in a GLP compliant study performed in accordance with standardised guidelines OECD 473 and EU Method B.10. The test substance in this study was the aldehyde of 3-methyl-5-phenylpentanol and as such is considered representative of the clastogenic effects expected with 3-methyl-5-phenylpentanol. The study was assigned a reliability score of 2, on the basis of read-across, in accordance with Klimisch (1997). Under the conditions of the test, the test substance was found to be non-clastogenic in human peripheral blood lymphocytes.

In vivo cytogenicity

The cytogenic potential of the test substance was determined in a GLP compliant study performed in accordance to a method similar to the standardised guidelines OECD 474 and EU Method B.12. Some deviations were noted in the study design concerning the sampling times of the controls and the lower dose groups, however this was not thought to affect the quality of the results or influence the conclusions of the study. The study was performed on a structural isomer of 3-methyl-5-phenylpentanol, the only difference between the two substances being the position of the methyl group. As such the results presented are considered to be representative of 3-methyl-5-phenylpentanol and an accurate reflection of its mutagenic potential. The study was performed to a good standard and was assigned a reliability score of 2, on the basis of read-across, in accordance with Klimisch (1997). Under the conditions of the test, the test substance did not induce chromosomal damage or damage to the mitotic apparatus in NMRI mice.

Justification for selection of genetic toxicity endpoint
No study was selected since both in vitro and the one in vivo study were all negative (see Discussion below).

Short description of key information:
IN VITRO GENE MUATION STUDY IN BACTERIA
Key study:- King (1988) Ames test (equivalent to OECD 471 and EU Method B.13/14); Non-mutagenic (tested on a structural isomer of 3-methyl-5-phenylpentanol)

IN VITRO CYTOGENICITY IN MAMMALIAN CELLS
Key study:- Wright (1999) Chromosome Aberration Test in Human Lymphocytes in Vitro (OECD 473 and EU method B.10); Non-clastogenic (tested on the aldehyde of 3-methyl-5-phenylpentanol)

IN VIVO CYTOGENICITY
Key study:- King (1989) Mammalian Erythrocyte Micronucleus Test (equivalent to OECD 474 and EU Method B.12); Not cytogenic (tested on a structural isomer of 3-methyl-5-phenylpentanol)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to Regulation EC 1272/2008 and Directive 67/548/EEC, the substance does not meet the criteria for classification as a mutagenic substance.