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Diss Factsheets
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EC number: 209-481-3 | CAS number: 582-25-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- Various
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Since potassium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties based on benzoic acid and its soluble salts.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS
- Author:
- European Commission
- Year:
- 2 002
- Bibliographic source:
- adopted by the SCCNFP during the 20th plenary meeting of 4 June 2002
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Various clinical studies performed
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- There is sufficient evidence to conclude that this class of substance is not a potential skin sensitiser.No further animal testing can be justified
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- Molecular formula:
- C7H6O2
- IUPAC Name:
- benzoic acid
Constituent 1
- Specific details on test material used for the study:
- Not specified
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Clinical studies
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Patch test
- Vehicle:
- not specified
- Concentration / amount:
- Various concentrations, up to 5%
- Adequacy of induction:
- other: Suitable for clinical studies
Challenge
- No.:
- #1
- Route:
- other: Patch test
- Vehicle:
- not specified
- Concentration / amount:
- Not specified
- Adequacy of challenge:
- other: Suitable for clinical studies
- No. of animals per dose:
- In one study, 5302 patients were examined
- Details on study design:
- Clinical patch tests
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Number of readings not specified
- Group:
- test chemical
- No. with + reactions:
- 34
- Total no. in group:
- 5 203
- Clinical observations:
- Not recorded
- Remarks on result:
- other: < 0.7% reaction
- Remarks:
- Considered negative
Any other information on results incl. tables
Details given in the review document are provided:
Patch test (48 h/occlusive) according to the ICDRG recommendations: 5 % benzoic acid in petrolatum, 627 patients. 8 patients showed positive reactions (1.3% of the tested). Some reactions may be interpreted as allergic but may have been irritant.
25 human volunteers were given five 48 h patch tests (during the 10 d period) with 2 % benzoic acid in petrolatum. None gave positive reactions when challenged 10-14 d after the induction phase by a final 48 h closed patch test with 2 % benzoic acid in petrolatum (only abstract available).
10 persons allergic to benzoyl peroxide were tested by a 48 h patch test with 5 % benzoic acid in a petrolatum. No reactions at 48, 72 and 96 h.
5203 patients with suspected contact dermatitis were patch tested with benzoic acid (no details were given). 34 patients (0.7 %) showed allergic reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The cited clinical studies all concluded negative
- Executive summary:
Details given in the review document are provided:
Patch test (48 h/occlusive) according to the ICDRG recommendations: 5 % benzoic acid in petrolatum, 627 patients. 8 patients showed positive reactions (1.3% of the tested). Some reactions may be interpreted as allergic but may have been irritant.
25 human volunteers were given five 48 h patch tests (during the 10 d period) with 2 % benzoic acid in petrolatum. None gave positive reactions when challenged 10-14 d after the induction phase by a final 48 h closed patch test with 2 % benzoic acid in petrolatum (only abstract available).
10 persons allergic to benzoyl peroxide were tested by a 48 h patch test with 5 % benzoic acid in a petrolatum. No reactions at 48, 72 and 96 h.
5203 patients with suspected contact dermatitis were patch tested with benzoic acid (no details were given). 34 patients (0.7 %) showed allergic reactions.
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