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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 209-042-6 | CAS number: 553-54-8
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Peer reviewed journal
Sodium and potassium benzoate both assessed, helping establish that the cation has little impact on the outcome of these tests
Although good method details included, the study was only performed in the absence of S-9 metabolic activation.
Data source
Reference
- Reference Type:
- publication
- Title:
- The evaluation of the genotoxicity of two food preservatives: Sodium benzoate and potassium benzoate
- Author:
- N. Zengin a, D. Yüzbas, et al
- Year:
- 2 010
- Bibliographic source:
- Food and Chemical Toxicology 49 (2011) 763–769
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- Principles of method if other than guideline:
- The slides were stained with Giemsa. The number of SCEs (25 cells from each donor, with two doners, making a total of 50 cells per concentration) under the second metaphases was scored. In addition, 100 cells from each donor were scored for determination of the replication index (RI).
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- Molecular formula:
- C7H6O2.Na
- IUPAC Name:
- sodium benzoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Obtained from Merck
(Note Potassium Benzoate also assessed)
Method
Species / strain
- Species / strain / cell type:
- other: Human
- Remarks:
- Two doners
- Details on mammalian cell type (if applicable):
- The study was carried out using blood samples from two healthy donors (nonsmokers, of age 25 years), with no medication for at least 3 weeks prior, and not having had a radiological examination within the prior 3 months.
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 6.25, 12.5, 25, 50, and 100 ug/ml for sodium benzoate, with reduction in mitotic index at over 12.5 ug/ml
62.5, 125, 250, 500, and 1000 ug/ml for potassium benzoate, with reduction in mitotic index at over 250 ug/ml - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- Whole blood from two doners was added to chromosome medium B (containing fetal bovine serum)
- Statistics:
- The t-test was applied
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: Human
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The same level of positive response was seen for potassium and sodium benzoate
Applicant's summary and conclusion
- Conclusions:
- These benzoate salts led to positive effects in-vitro without S-9
The same level of positive response was seen for potassium and sodium benzoate suggesting that the metal ion is not significant in considering possible mutagenic effects, although the metal ion did influence cyto-toxicity (sodium being more toxic than potassium).
These results are in line with other publications and reviews of in-vitro assessment of benzoate salts.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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