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No study available.

Key value for chemical safety assessment

Justification for classification or non-classification

The test substance Vulcuren was shown to be not genotoxic in an in vivo micronucleus assay (Bayer AG 2000c) and in vivo Comet assay (Lanxess GmbH 2005). No evidence of pre-neoplastic lesions was found in a repeated dose study with male and female Wistar rats (Bayer AG 2000d). There was no evidence of any gross pathological and histopathological findings associated to dosing with the test substance up to the highest dose group evaluated. Vulcuren (purity: 99.7%) has a very low local irritation potential on mucous membranes in an eye irritation study in rabbits (LPT 1999). In addition, no effects were detected on the gastrointestinal tract in an oral repeated dose study (Bayer AG 2000d). Overall it can be concluded that there is no evidence to anticipate a carcinogenic potential of Vulcuren based on the absence of a genotoxic potential in vivo and no observation of pre-neoplastic lesions in an oral repeated dose study.

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