Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Reliable data are available for tetrahydro-2-methylfurna from studies on in vitro mutagenicity to bacterial and mammalian cells. Information for cytogenicity is available from two studies, one in vitro and the other in vivo, where the reliability is not assignable as there are insufficient details in the publication.

Tetrahydro-2-methylfuran has been tested for mutagenicity to bacteria using a method that is comparable to OECD TG 471 (Seifried, H.E. et. al. (2006)). The result is reported as negative with and without metabolic activation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102. Solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. This result is supported by a study in which tetrahydro-2-methylfuran was tested for mutagenicity to bacteria using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA (Antonucci, V. et. al. (2011)). No substantial increases in revertant colony counts were obtained in the presence or absence of metabolic activation. The information on method and results included in the publication is limited, so the reliability is 4. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

An investigation into the mutagenicity of tetrahydro-2-methylfuran has been reported (Seifried, H.E. et. al. (2006)). The method used is similar to OECD TG 476, and the study is considered to be reliability 2. The authors of the publication report that the test substance was negative for mutagenicity to L5178Y cells without metabolic activation, but that the result with metabolic activation was inconclusive; however, the data presented do not include clear evidence of a substance-related, dose-dependent increase in mutant frequency, so it is the conclusion of the reviewer is that the test substance is negative for mutagenicity to mammalian cells under the conditions of the test.

Tetrahydro-2-methylfuran has been tested for cytogenicity in peripheral human lymphocytes (Antonucci, V. et. al. (2011)). No statistically significant increase in the proportion of cells with chromosome damage was observed. The information on method and results included in the publication is limited, so the reliability is 4. It is concluded that the test substance is negative for clastogenicity (induction of chromosome aberrations) under the conditions of the test.

Tetrahydro-2-methylfuran has been tested for induction of micronuclei in vivo (Antonucci, V. et. al. (2011)). The information on method and results included in the publication is limited, so the reliability is 4. No induction of micronuclei was observed, and no effect on the proportion of polychromatic erythrocytes was noted in male or female mice after three months treatment by oral gavage. It is concluded that the test substance is negative for the induction of micronuclei.


Justification for selection of genetic toxicity endpoint
The most reliable of the available studies, conducted according to protocols equivalent or similar to appropriate OECD guidelines.

Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 (similar to OECD 471) (Seifried, H.E. et. al. (2006)).
Cytogenicity in mammalian cells: negative with and without metabolic activation in cultured human lymphocytes (reliablity 4 study, similar to OECD TG 473) (Antonucci, V. et. al. (2011)).
Mutagenicity in mammalian cells: negative in L5178Y mouse lymphoma cells (similar to OECD TG 476) (Seifried, H.E. et. al. (2006)).

In vivo:
Micronucleus assay oral (gavage) study in rat: Negative after 3 months administration (reliablity 4 study, similar to OECD 474) (Antonucci, V. et. al. (2011)).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available in vitro and in vivo genotoxicity data, tetrahydro-2-methylfuran is not classified for mutagenicity according to Regulation (EC) No 1272/2008/EC.