Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Sorbic Acid and its salts are non-mutagenic and non-clastogenic in vitro and in vivo. In extreme conditions (high concentration and temperature) Sorbic Acid may react with nitrite to form mutagenic products but these mutagens are not detectable under normal conditions of use. Sorbic Acid and Potassium Sorbate have been tested for mutagenic effects using among others the Ames test, genetic recombination tests, reversion assays, recombination (rec) assays, micronucleus test, tests for chromosomal aberrations, sister chromatid exchanges (SCE) and gene mutations. Results have been both positive and negative. This is due to the use of different concentrations and combinations of tested substances and because the data compiled is often not directly comparable. Especially in the older data, no details about the preparation and storage of the compounds is given, i.e. it is unclear whether fresh or stored solutions were used. Moreover tested cell types and genetic end points widely differ. The authors of a comprehensive review summarizing the results of 16 in vitro genotoxicity tests in tabular form concluded that Sorbic Acid and its potassium salt can be considered safe with respect to genotoxicity and carcinogenicity. In section 3.2.2.2 of this dossier numerous in vitro and in vivo studies of genotoxicity are provided - among others one study carried out according to OECD guideline 474 (1983) and one study carried out according to a method similar to method B.18 (88/303/EC) in 1989. The overall conclusion of all studies is that Sorbic Acid and Potassium Sorbate is safe with regard to genotoxicity.


Short description of key information:
Sorbic Acid and Potassium Sorbate have been tested for mutagenic effects using among others the Ames test, genetic recombination tests, reversion assays, recombination (rec) assays, micronucleus test, tests for chromosomal aberrations, sister chromatid exchanges (SCE) and gene mutations. Results have been both positive and negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to regulation (EC) No 1272/2008, sorbic acid and potassium sorbate are classified negative based on the in vivo genotoxicity studies.