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Toxicological information

Carcinogenicity

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Description of key information

The analogue chemicals, linalool and linalyl acetate, failed to produce lung or skin tumors, respectively, in susceptible strains of mice. Dihydromyrcenol was negative for mutagenicity when tested in vitro in either bacterial or mammalian cells. It was also negative in vitro in a cytogenetic assay in human lymphocytes.

Key value for chemical safety assessment

Additional information

Dihydromyrcenol has not been tested for carcinogenicity. The analogue chemical, linalool, and the acetate derivative, linalyl acetate, were negative for increased lung tumors in susceptible strain A/He mice after intraperitoneal administration 3x/week for 8 weeks at a total maximum dose of 3 g/kg bwt total dose (linalool) or 24 g/kg bwt total dose (linalyl acetate) (Stoner et al., 1973). In addition, linalyl acetate was negative for skin tumors when 3 mg were applied to the skin of female ICR Swiss Ha mice 3 times per week for 67 weeks either alone or when co-administered with 1 microgram of the carcinogen benzo-[a]-pyrene (VanDuuren et al., 1971). However, when co-administered with 5 micrograms of benzo[a]pyrene, a weak co-carcinogenic response was noted.

Dihydromyrcenol was negative when tested in vitro in the Ames bacterial mutagenicity assay and in the mouse lymphoma L5178Y TK +/- mutagenicity assay and did not increase the rate of chromosomal aberrations in human lymphocytes in vitro.

Stoner G.D. , Shimkin M.B. , Kniazeff A.J. , Weisburger J.H. , Weisburger E.K. and Go G.B. (1973) Test for carcinogenicity of food additives and chemotherapeutic agents by the pulmonary tumor response in strain A mice. Cancer Research, 33(12), 3069-3085.

Van Duuren B., Blazej T., Goldschmidt B. Katz C., Melchionne S., and Sivak A. (1971) Cocarcinogenesis studies on mouse skin and inhibition of tumor induction. Journal of the National Cancer Institute 45(5), 1039-1044.

Please refer to Section 13 of this IUCLID file for read-across documentation and rationale for the use of analogue chemicals for dihydromyrcenol.

Justification for classification or non-classification

Dihydromyrcenol would not be rated as a carcinogen under either the EU DSD classification system (EU Directive 67/548/EEC) or the EU CLP classification system (EU Regulation 1272/2008), based on the results of negative carcinogenicity studies with the structurally similar monoterpene alcohol, linalool, and the acetate derivative, linalyl acetate, as well as negative findings with the subject material when tested for mutagenicity and cytogenicity in vitro.