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Key value for chemical safety assessment

Additional information

In vitro

Genetic toxicity was evaluated in a bacterial reverse mutation assay performed under GLP according to OECD guideline 471. Bacteria strains TA98, TA1535, TA1538, TA100 and TA1537 were treated with concentrations up to 2500 μg/plate with and without Aroclor 1254 induced rat S-9 liver enzyme mix. As result, vanadyl pyrophosphate was not mutagenic under the conditions of test.

Genetic toxicity in mammalian cells was analyzed in a mammalian chromosome aberration test which was performed under GLP according to OECD guideline 473. BTN/A treated human lymphocyte cultures treated with 40 μg/mL without metabolic activation and treated with a concentration of 200 μg/mL with metabolic activation by Aroclor 1254 induced rat S-9 liver enzyme mix showed several cases of chromatid separation. Although this effect was more pronounced at the higher concentration of vanadyl pyrophosphate used in the preliminary study, this effect is believed to indicate a non-specific effect on chromosome morphology. However, as this is not an indicator of clastogenic activity of the test material, no mutagenicity was found.

Due to the lack of an in vtro mutagenicity study, a published study with the structural analogue vanadium oxide sulphate was used for read-across (Galli et al., 1991). As result, no gene mutation in the HPRT locus of V79 cells was found when the cells were treated with concentrations of 1, 2, 5 and 7.5 mM with and without metabolic activation by mouse hepatic S-9 mix.

In vivo

The in vivo exposure of male and female CD-1 mice with oral doses of 500, 1000, 2000 mg/kg did not induce chromosome aberrations.

Short description of key information:
in vitro:
- gene mutataion in bacteria: negative
- gene mutation in mammalian cells: negative
- chromosome aberration in mammalian cells: negative

in vivo
- chromosome aberration (mouse): negative

Endpoint Conclusion:

Justification for classification or non-classification

The available data on genetic toxicity in vitro and in vivo are conclusive but not sufficient for classification.