Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ames Test:

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 WP2uvrA were exposed to Tellurium, (powder 99.95 % 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).

Tellurium had no mutagenic activity in the bacterium tester strains under the test conditions used in this study.

Chromosomal Aberration Test with Tellurium dioxide

The read-across substance Tellurium dioxide was tested according to OECD guideline 479 in vitro in a Chromosome Aberration Assay using Chinese hamster V79 lung cells . The test item was examined up to the cytotoxic concentrations according to the relevant OECD guideline covering the range from cytotoxicity to no or little cytotoxicity.

Treatment with the test item did not result in a repeatable, statistically and biologically significant increase in the frequency of the cells with structural chromosome aberrations without gaps either in the presence or absence of a metabolic activation system.

Mammalian Cell Gene Mutation Test with Tellurium dioxide:

An in vitro mammalian cell assay according to OECD Guideline 476 was performed in mouse lymphoma L5178Y TK+/- cells at the tk locus to test the potential of Tellurium dioxide to cause gene mutation and/or chromosome damage. Treatment was performed for 3 hours with and without metabolic activation (±S9 mix) and for 24 hours without metabolic activation. The evaluated concentration ranges covered the range from cytotoxicity to no or little cytotoxicity.

 

Statistical significant increase was observed, however taking into account the global evaluation factor no biological relevant mutagenic effect of tellurium dioxid, was found either in the presence or in the absence of metabolic activation system under the conditions of this Mouse Lymphoma Assay.

Justification for read-across is outlined in the attached document.

 


Justification for selection of genetic toxicity endpoint
Reliable data are available from the full in-vitro test set required under REACH regulation.

Short description of key information:
Negative data are available from a gene mutation assay in bacteria with tellurium. As well negative data were obtained from a chromosomal aberration test and a mammalian cell gene mutation assay with the read-across substance tellurium dioxide.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on all available information the substance is devoid of any relevant genotoxic potency.