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Description of key information

Overall, dietary levels up to 10% of sorbic acid for 80 weeks in mice and 2 years in rats caused no carcinogenic effects.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
1 400 mg/kg bw/day

Additional information

Potassium Sorbate at 0.1% in the diet or 0.3% in drinking water of rats for up to 100 weeks produced no neoplasms. In other chronic studies, no carcinogenic effect was demonstrated by Sorbic Acid in rats or mice fed diets containing up to 10% Sorbic Acid. Also rats fed at 10% of Sorbic acid for 3 years caused no carcinogenic effects.

The extrapolation effect from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determinant of potential toxicity is the sorbate anion.

Justification for classification or non-classification

According to regulation (EC) No 1272/2008, potassium sorbate and sorbic acid are not carcinogenic.