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Carcinogenicity

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Description of key information

no evidence of oncogenic potential in rats
no evidence of oncogenic potential in mice

Key value for chemical safety assessment

Justification for classification or non-classification

There was no evidence of any oncogenic effect in the chronic/carcinogenicity studies (rat, mouse). As a result the substance does not meet the criteria for classification (carcinogenic substances) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 4.2.1.

There was no evidence of any oncogenic effect in the chronic/carcinogenicity studies (rat, mouse). As a result the substance does not meet the criteria for classification (carcinogenicity) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.6.2.

Additional information

Data is available from two studies in two different species. There was no evidence of oncogenic effect of the test substance on rats and mice, when administered in the diet (life-span of the animals), at the highest dose. The maximum dose administered was 3.0 mg/kg bw/day of the racemate.

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