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Diss Factsheets
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EC number: 246-376-1 | CAS number: 24634-61-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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