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Additional information

HiTEC 7134 was tested for its mutagenic potential in bacterial cells of Salmonella and Escherichia, with and without metabolic activation. Two separate bacterial gene reverse mutation assays (Ames test) were conducted. One of the studies was used as a key study, while the other as a supporting study.Both satisfy the requirements of OECD Guideline 471. In the key study, HiTEC 7134 did not exert a mutagenic effect to any of the tester strains in the presence or absence of metabolic activation. The cytotoxicity of HiTEC 7134 was not evaluated, but the compound did precipitate at concentrations of 2500 µg/plate and above.  Consequently, on the basis of this result H7134 may be deemed as non-mutagenic on bacterial cells under the particular conditions.

This is further supported by the second Ames test, where H7134 tested negative, using both liquid pre-incubation and plate incorporation treatments, in the presence and absence of metabolic activation. A significant increase was seen in the initial test with TA1535 at a dose of 5 µg/plate without S9 and in E. coli WP2 uvrA at several tested concentrations with S9. However, these results were not dose dependant nor were they reproducible in a second test. In addition, all revertant frequencies in all tests were within the historical control range. The compound was cytotoxic at concentration of 500 µg/plate and above. 

HiTEC 7134 was evaluated for its clastogenic potential in an in vitro cytogenetic assay using human lymphocytes in two separate experiments in the presence and absence of metabolic activation. The study was performed in accordance with the OECD Guideline 473. No statistically significant increases in the percentage of aberrant cells, compared to the solvent control values, were recorded in cultures from either experiment treated in either the presence or absence of S9-mix, but the compound was cytotoxic at concentrations of 75 µg/ml and above. Therefore, it was concluded that H7134 does not induce chromosomal aberrations to human lymphocytes when tested under the specific conditions. 

Short description of key information:
The mutagenic potential of HiTEC 7134 was assessed in three in vitro studies: 2 Ames tests and 1 cytogenetic assay on human lymphocytes. The test material may be considered as non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification