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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

According to REACH Annex VII and XI (section 1), an in vitro gene mutation study (required in section 8.4.1) is not considered necessary, since adequate data from an in vivo carcinogenicity study are available showing no neoplastic findings in rats after 2 years of exposure (see summary of study in respective paragraphs). Therefore, the substance can not be genotoxic in vivo, and thus no in vitro study is required.

Additional information

Data are available with the target's analogue sodium ferrocyanide, from a long-term exposure study via feed showing no dose-related carcinogenicity. Since no dose-related carcinogenicity was observed up to the highest concentration (450 mg/kg/day) after exposure for two years, it is concluded that sodium ferrocyanide is not genotoxic and that further testing is not necessary.

Endpoint Conclusion:No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, the target's analogue sodium ferrocyanide was found not to be mutagenic. Therefore potassium ferrocyanide does not need to be classified for mutagenicity according to CLP Regulation (No) EC 1272/2008.

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