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Toxicological information

Endpoint summary

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Key value for chemical safety assessment

Effects on fertility

Description of key information

E131 Patent blue V is non toxic for reproduction.

Additional information

As reported in EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) no adverse effect were observed in 65 male and female mice oral treated by 150, 500 and 1500 mg/kg bw/day of E131 Patent blue V for 9 weeks. Based on this study, the NOAEL of reproductive toxicity of E131 Patent Blue V is 1500 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

There is no concern for developmental toxicity of E131 Patent blue V sodium salt.

Additional information

A developmental toxicity study is reported in the document EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS): the NOAEL of developmental toxicity of E131 Patent Blue V calcium salt is 500 mg/kg bw/day.

Justification for classification or non-classification

Not classified for reproductive and developmental toxicity according to the CLP Regulation (EC.1272/2008). For justification see additional information.