Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Dihydromyrcenol has been tested for genetic toxicity in vitro in three key studies including the Ames mutagenicity assay, the mouse lymphoma L5178Y TK +/- mutagenicity assay and the human lymphocyte chromosomal aberration test. In a well-conducted study following OECD Guideline 471, dihydromyrcenol was negative for mutagenicity when tested in Salmonella sp. strains TA98, TA100, TA1535 and TA1537 and in E. coli strain WP2uvrA-, up to a limiting plate incorporation level of 5000 micrograms/plate, either with or without metabolic activation using rat liver S9. In a well conducted study following OECD Guideline 476, dihydromyrcenol was negative in the mouse lymphoma L5178Y TK +/- cell line, either with or without rat liver S9 activation. Also in a well-conducted study following OECD Guideline 473, dihydromyrcenol failed to produce a significant increase in chromosomal aberrations in human lymphocytes, either in the presence or absence of rat liver S9 activation.

Dihydromyrcenol has not been tested for mutagenicity in an in vivo assay. Given 3 clearly negative in vitro genetic toxicity tests, further in vivo testing is not required.


Short description of key information:
In vitro mutagenicity assays in Salmonella sp. strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2uvrA-. Mammalian cell mutagenicity has been determined in an in vitro assay with mouse lymphoma L5178Y TK +/- cells. Also, cytogenicity was determined in a chromosomal aberration test in human lymphocytes.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dihydromyrcenol was negative when tested in vitro in the Ames bacterial mutagenicity assay and in the mouse lymphoma L5178Y TK +/- mutagenicity assay. It also failed to produce a positive response in the human lymphocyte chromosomal aberration test. Based on the results of these in vitro studies, dihydromyrcenol would not be rated as a mutagen under either the EU DSD classification system (EU Directive 67/548/EEC) or the EU CLP classification system (EU Regulation 1272/2008), and UN-GHS.