Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
In a reverse gene mutation assay in bacteria according to OECD guideline 471, strains TA 1535, TA 1537, TA98 and TA100 of S. typhimurium and E. coli WP2 uvrA were exposed to Tellurium dioxide, (powder 99.9 % a.i.), at concentrations up to 5000 µg/plate in the presence and absence of mammalian metabolic activation, (S9 mix; phenobarbital/β-naphthoflavone induced rat liver).
The initial Mutation Test was performed as plate incorporation method; the confirmatory and complementary assays were performed according to the pre-incubation method.
In the Initial Mutation Test, Confirmatory Mutation Test and Complementary Confirmatory Mutation Test, none of the observed revertant colony numbers were above the respective biological threshold value. There were no consistent dose-related trends and no indication of any treatment effect. In all test item treated groups, the numbers of revertant colonies were below the biological relevance when compared with the solvent controls and were within the historical control range and were within the normal biological variability of the test system.
Inhibitory, cytotoxic effect of the test item was observed in the Initial Mutation Test in all tester strains with and without metabolic activation at the two or three highest concentration. Similar, but stronger cytotoxic effect was observed using the preincubation method (Confirmatory Mutation Test and Complementary Confirmatory Mutation Test) in all tester strains with and without metabolic activation.
The mean values of revertant colonies of the solvent control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was confirmed by a plating experiment in each test. At least five analyzable concentrations were presented in all strains of the main tests. The tests were considered to be valid.
In conclusion there was no evidence of induced mutant colonies over background.
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