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Diss Factsheets
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EC number: 213-361-6 | CAS number: 939-48-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: other: chromosome damage and dominant lethal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This is a summary of studies reviewed by an authoritative body(Scientific Committee on Food), which accepted the data as scientifically valid.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guidelines 475 and 478
- Principles of method if other than guideline:
- summary of OECD 475 and 478 tests
- GLP compliance:
- not specified
- Type of assay:
- other:
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- IUPAC Name:
- sodium benzoate
- Reference substance name:
- benzoic acid, sodium salt
- IUPAC Name:
- benzoic acid, sodium salt
- Details on test material:
- sodium benzoate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- single or repeated dosing (5 days)
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 500 and 5000 mg/kg bw/day
Basis:
nominal conc.
Examinations
- Tissues and cell types examined:
- bone marrow for the chromosome aberrations assay, and uterine implantation sites in pregnant female rats for the dominant lethal assay.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
This is a summary from the Opinion of the SCF on benzoic acid and its salts: a chromosomal aberration assay was carried out in bone marrow cells of Sprague-Dawley rats exposed by gavage to single or repeated doses for 5 consecutive days of 50, 500 and 5000 mg/kg bw/day sodium benzoate, with negative results. Also, a dominant lethal test using 50, 500 or 5000 mg/kg bw/day as a single or multiple (5 days) doses to male Sprague-Dawley rats was negative.
While some of the in vitro tests have been positive or equivocal (for benzoic acid and its salts), all the results fromin vivostudies have been negative. It is therefore concluded that an in vivo study for clastogenic activity on benzoic acid (previously requested, SCF, 1994) should no longer be required.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The SCF reveiwed available in vivo data on the genotoxicity of sodium benzoate (and other related substances) and concluded that the substance is not mutagenic in vivo. This study is informative for evaluation of the toxicity of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
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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