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Diss Factsheets
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EC number: 208-534-8 | CAS number: 532-32-1
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: LgE was used as marker, placebo controls were included, limited data to allow definite conclusions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Sodium benzoateinduced repeated episodes of acute urticaria/angiooedema: randomized controlled trial
- Author:
- Nettis E., Colanardi M. C., Ferrannini A. and Tursi A.
- Year:
- 2 004
- Bibliographic source:
- British Journal of Dermatology, 151: 898– 902
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A total of 47 subjects were enrolled in the study: 29 (62%) subjects were female and 18 (38%) male. Tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance. The test substance was given at increasing dosage: 25 mg, 50 mg and 100 mg.
- GLP compliance:
- not specified
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
- Reference substance name:
- Benzoic acid, sodium salt
- IUPAC Name:
- Benzoic acid, sodium salt
- Details on test material:
- No data given
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- This was a retrospective study based on the analysis of data from patients reported to have experienced episodes of urticaria, with or without angio-oedema, after ingesting meals or products containing the test substance. At the first visit to the outpatients clinic, a careful history was taken. Patients were then given the following diagnostic tests: tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance.
Results and discussion
- Results of examinations:
- A total of 47 subjects were enrolled in the study; five (11%) showed at least one relevant positive reaction to an IgE test for food allergy. Only one subject (2%) had a reaction after the ingestion of 75 mg of the test substance without an adverse reaction to placebo.
Applicant's summary and conclusion
- Conclusions:
- This study shows that the percentage of repeated episodes of acute urticaria/angio-oedema reactions induced by the test substance is very low (2%).
- Executive summary:
A total of 47 subjects were enrolled in the study: 29 (62%) subjects were female and 18 (38%) male. Tests for IgE for common inhalant allergens and food allergens, and a double-blind, placebo-controlled challenge with the test substance. The test substance was given at increasing dosage: 25 mg, 50 mg and 100 mg. This study shows that the percentage of repeated episodes of acute urticaria/angio-oedema reactions induced by the test substance is very low (2%).
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