Eucalyptus maculata citriodora, ext.

Endpoint summary

Additional information

Gene mutation in bacteria (OECD 471)

The genotoxicity of the test substance Eucalyptus citriodora was tested in bacteria according to OECD guideline 471 (Ames test) two experiment (plate incorporation and pre-incubation). Cytotoxicity was observed in both experiments by a reduction in growth of the bacterial background lawns, being more apparent in the experiment using plate incorporation methodology. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. The test item was considered to be non-mutagenic to bacteria.

 

In vitro mammalian chromosome aberration test (OECD 473)

Genotoxicity of the test substance Eucalyptus citrodora was determined in an in vitro chromosome aberration test according to OECD guideline 473. Cytotoxicity was observed in all three exposure groups at higher doses (inhibition up to 68%). No significant changes in frequency of cells with aberrations and the number of polyploid cells was observed. The test substance did not induce any toxicologically significant increase in frequency of cells with chromosome aberrations with or without metabolic activation. It was therefore considered to be non-clastogenic to human lymphocytes in vitro.

 

In vitro mammalian cell gene mutation test (OECD 476)

The genotoxicity of Eucalyptus citriodora was tested in mouse L5178Y lymphoma cells according to OECD guideline 476. Two experiments were performed, one with and without presence of S9 for 4 hours and one for 24 hours without presence of S9. Evidence of marked dose-related (cyto)toxicity following exposure to the test item was found in both experiments (with or without S9). In the 4-hours exposure experiment no effect on viability was found, although modest reduction in viability was found in the 24-hours exposure experiment (indicating residual toxicity). The test article did not induce statistically significant (dose related) increase in the mutant frequency at the TK +/- locus in L5178Y cells in the 4 -hour exposure experiment (with S9) and the 24-hours exposure experiment (without S9). The test item was therefore considered to be non-mutagenic to mouse lymphoma cells in vitro.

Justification for selection of genetic toxicity endpoint

No selection is made as a Weight of Evidence approach was followed which is described below.

Short description of key information:

- Gene mutation in bacteria: not mutagenic (OECD 471)

- In vitro mammalian chromosome aberration test: not clastogenic (OECD 473)

- In vitro mammalian cell gene mutation test: negative (OECD 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Eucalyptus Citriodora did not show any genotoxic potential in three genotoxicity tests. Therefore, it can be concluded that the substance is not genotoxic and does not need to be classified for genotoxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).