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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
Endpoint summary
Administrative data
Description of key information
The Human Cornea Model Test with potassium benzoate had almost exactly the same score as lithium benzoate and it was decided to read-across and classify potassium benzoate as Eye Dam 1
For the same reason, it was considered valid to read-across to the skin endpoint and classify potassium benzoate as Skin Irrit 2 based on the lithium benzoate conclusions.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 60 minute exposure
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study performed to guidelines under GLP conditions
The Potassium salt appears to be a less severe irritant to eyes than the concurrently tested Lithium salt; therefore, it is safe to consider this to be a suitable read-across model to allow classification as skin Irrit 2 - Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name Lithium benzoate
Batch no. 16B/02
Appearance white powder
Composition Lithium benzoate > 98%
Purity min. 98.0 %
Homogeneity homogeneous
Expiry date 09. Jun. 2019 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The tissues were wetted with 25 µL Dulbecco’s Phosphate Buffered Saline (DPBS) buffer before applying the test item
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- ca 25 mg applied and spread over surface of wetted tissue
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 23 hours at 37C
- Number of replicates:
- three
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 14
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Range of viablity 13.8 - 14.4 % (mean 14.1%).
Positive control 3.5 - 3.9% (mean 3.7%) - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The relative absorbance values were reduced to 14.1% after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin. A corrosive test was performed on lithium benzoate and it is concluded that it is not Corrosive.
- Executive summary:
Data for lithium and potassium benzoate indicates that there is the same level of potential irritation and read-across is valid.
Public data for potassium benzoate concludes it is non-corrosive.
It is concluded that potassium benzoate is Skin Irrit 2, Eye Dam 1
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. 2.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the test system, Potassium benzoate is considered as eye irritant in the EpiOcularTM Eye Irritation Test.
After treatment with the test item, the relative absorbance values were reduced to 2.5 %.
This value is below the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled
The positive control induced a decrease in the relative absorbance as compared to the negative control to 39%. - Executive summary:
Note the viability score of 2.5 is almost identical to that of lithium benzoate (2.6) and this was concluded to be Eye Dam 1 as a result of an subsequent BCOP study
For this reason, it is proposed to classify potassium benzoate as Eye Dam 1.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
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