Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Valid experimental data were available to assess the genetic toxicity of tetrahydrolinalool in-vitro.

Gene mutation in bacteria

In the key study according to OECD TG 471 and GLP, tetrahydrolinalool was evaluated for mutagenic activity in the Ames test (DSM B-167764) using the Salmonella typhimurium strains TA1535, TA97, TA98, TA100, and TA102 in the presence and absence of an exogenous metabolic activation system (rat liver S9). No significant increase in the number of revertant colonies was apparent in all five test strains after treatment with tetrahydrolinalool up to cytotoxic concentrations.It is therefore concluded, that neither tetrahydrolinalool nor respective metabolites are mutagenic in the Ames test under the described experimental conditions.

Further data, available in a summary publication, confirm that tetrahydrolinalool was not mutagenic in an Ames test with and without metabolic activation and tested up to 3600 μg/plate in Salmonella typhimurium TA1535, TA 1537, TA 98, TA 100 and TA 1538; metabolic activation consisted of liver S-9 mix from Aroclor-induced male rats (Wild 1983).

 

Gene mutation in mammalian cells

In the chosen key study, tetrahydrolinalool did no induce gene mutations in a HPRT assay using V79 cells (according to OECD TG 476 and GLP) up to cytotoxic concentrations with and without metabolic activation (BASFAG 50M0021/989002).

 

Cytogenicity in mammalian cells

In the chosen key study, i.e. a chromosomal abberation assay according to OECD TG 473 and GLP using V79 Chinese hamster fibroblasts, tetrahydrolinalool was found to be negative for causing chromosomal abberations up to cytotoxic concentrations with and without metabolic activation (BASFAG 32M0021/989001).

 

The test substance tetrahydrolinalool was found to be not mutagenic and not clastogenic in in-vitro experiments using rodent and bacterial cells.


Short description of key information:
Gene mutation in bacteria: S. typhimurium TA 1535, TA 97, TA 98, TA100 and TA 102, with and without metabolic activation (Ames test, OECD 471, GLP): negative (DSM B-167764)
Gene mutation in mammalian cells: V79 (HPRT test; OECD 476, GLP), with and without metabolic activation: negative (BASFAG 50M0021/989002)
Cytogenicity in mammalian cells: V79 (in vitro chromosomal abberation test; OECD 473, GLP), with and without metabolic activation: negative (BASFAG 32M0021/989001)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC and therefore, a non-classification is warranted.