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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Carcinogenicity

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Administrative data

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
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
1 400 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Quality of whole database:
acceptable, reasonably wel documented

Justification for classification or non-classification

A fair evaluation of the results did not show evidence of any arcinogenecity potential for sorbic acid or potassium sorbate.

According to regulation (EC) No 1272/2008 and recent EFSA scientific opinion (2015) concluded that sorbic acid did not exhibit any signs of carcinogenicity in this study.

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 on the sorbate anion.