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Key value for chemical safety assessment

Additional information

All in vitro assays are negative except the mouse lymphoma test, which was positive only at cytotoxic concentrations under acidic pH shift conditions. Therefore (and as concluded by the EU RAR , 2002) this effect is deemed to be due to the pH shift and not comsidered as a positive test outcome.it is well known that changes in pH can be the cause of an increased mutation frequency

The results from all valid in vivo assays, covering multiple endpoints in various organs are all negative. One study, considered invalid because of poor reporting, mentioned an increase in chromosomal aberrations, but, in accordance with the EU RAR (2002) this study was disregarded.


Short description of key information:
multiple in vitro genetic toxicity studies are available, covering several types of bacterial mutation assays (negative), mammalian cell chromosome aberration (assays negative),sister chromatid assays (negatvie) , a HPRT assay (negative), a comet assay (negative) and a mouse lymphoma assay( false positive) In vivo studies are available in insects (drosphila mutatiions, negative), amphibians (mouse micronucleus, negative)and rodents (DNA strand braks, negative). See entries in 7.6.1 and 7.6.2 for guideline specifications.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In vitro: negative

in vivo: negative.

Negative in 2 -year carcinogenicit studies in rats and mice.

Conclusion: not a genotoxic substance.