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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
Assessment has been made based on the well established toxicity profile of benzoate (specifically sodium benzoate)
There is no evidence of toxicity from potassium at concentrations leading to classification.
Potassium is an essential element and there is a recommended daily intake of 4700 mg/day for adults (ca 67 mg/kg based on 70 kg adult). The recommended daily intake for children is > 70 mg/kg/day.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- weight of evidence
- Study period:
- Review document
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- As with all salts, the significance for toxicity assessment is the presence of specific ions that will form when in solution or when in biological systems. In the case of metal salts of organic acids, the cation is generally critical to determine the solubility and bioavailability if the key physico-chemical properties are equivalent, the potential for absorption if ingested and hazard will be equivalent; this is especially so for potassium and sodium salts that share similar solubility and dissociation characteristics.The cation is only critical in determining hazard if this is itself hazardous, but if the metal cations are present in the diet or are ‘essential’ elements for health, then there should be little to differentiated long-term hazards. Potassium is essential in the diet, Read-across to sodium salts and the benzoic acid is therefore considered valid.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A review of literature from a number of national and international reviews relating to use of lithium and benzoates salts in food and pharmaceuticals has been made to assess potential toxicity of potassium benzoate.
In view of the wealth of data on these ions, and in view of the necessity to avoid new animal testing, it is considered justified to perform this review. - GLP compliance:
- no
- Test type:
- other: Various methods used to assess toxicity of potassium and benzoate salts
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- The review is based on a number of oral toxicity studies, predominantly using rats.Different methods of oral administration are specified, but data is derived from sources using gavage.
- Doses:
- Primary data on lithium and benzoate salts include details of mortality at doses exceeding tolerated levels
- Control animals:
- not specified
- Details on study design:
- A review has been made based on a number of sources of information covering potassium and benzoate salts
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose level causing mortality not estimated
- Clinical signs:
- other: Clinical signs of intoxication (for benzoates in rats) included diarrhoea, muscular weakness, tremors, hypoactivity and emaciation. No clinical signs of over exposure in humans has been reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 is estimated on the basis that potassium does not impact on the toxicity.
No further animal testing is justified and the substance need not be classified under CLP - Executive summary:
Potassium benzoate, sodium benzoate and benzoic acid have all been extensively reviewed by national and international agencies.
Reference
The LD50 is estimated on the basis that potassium does not impact on the toxicity.
No further animal testing is justified and the substance need not be classified under CLP
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Extensive reviews by national and international regulatory agencies on benzoate salts.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
There are limited data relating to dermal absorption of lithium and benzoate ions.
Benzoic acid and sodium benzoate have been assessed for acute dermal toxicity and these are not considered hazardous and are not classified.
One source of data is in the opinion of the scientific committee on cosmetic products and non-food products intended for consumers (European Commission 2002). This review is based on a number of primary sources of data and is considered sufficient to confirm that these salts are of low dermal toxicity.
No further animal testing can be justified.
Reviews have been found, published by:
World Health Organisation, International Programme on Chemical Safety (IPCS)
http://www.inchem.org/documents/cicads/cicads/cicad26.htm
Scientific Committee On Consumer Products, Opinion on Benzoic Acid and Sodium Benzoate, 2005
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_015.pdf
SIDS INITIAL ASSESSMENT PROFILE: Benzoates, 2001
http://www.chemicals.moew.government.bg/chemical/site/File/registers/profile/BENZOATESp.pdf
http://www.inchem.org/documents/sids/sids/BENZOATES.pdf
Benzyl Alcohol, Benzoic Acid, and its Salts and Ester, CIR Expert Panel Meeting 2011
http://www.cir-safety.org/sites/default/files/119_draft_benzyl.pdf
Justification for classification or non-classification
Potassium and sodium benzoate and benzoic acid have all been extensively reviewed by national and international agencies.
Clinical signs of intoxication for benzoates in rats included diarrhoea, muscular weakness, tremors, hypoactivity and emaciation. No clinical signs of over exposure in humans has been reported.
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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