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Diss Factsheets
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EC number: 209-042-6 | CAS number: 553-54-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Since lithium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties of other lithium salts and on benzoic acid and its soluble salts.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- Various methods used to test this class of substance
- Principles of method if other than guideline:
- Lithium salts, benzoic acid and benzoate salts have been extensively reviewed for medical and cosmetic use.There is no evidence from human trials or animal studies of sensitisation potential
- GLP compliance:
- no
- Type of study:
- other: Various methods, including human patch tests
- Justification for non-LLNA method:
- New animal testing is not considered appropriate.
Test material
- Reference substance name:
- Lithium benzoate
- EC Number:
- 209-042-6
- EC Name:
- Lithium benzoate
- Cas Number:
- 553-54-8
- Molecular formula:
- C7H6O2.Li
- IUPAC Name:
- lithium benzoate
Constituent 1
- Specific details on test material used for the study:
- Lithium benzoate has been assessed on the basis of work conducted on lithium salts and on benzoic acid and its salts.
In vivo test system
Test animals
- Species:
- other: Many human studies included
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- Not specified
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- Not specified - applied to intact skin
- Adequacy of challenge:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Not specified
- Group:
- test chemical
- Dose level:
- Not specified
- No. with + reactions:
- 0
- Clinical observations:
- Not specified - none reported
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Assessed as negative.New animal testing is not warranted.
- Executive summary:
Since lithium benzoate will dissociate under biological conditions, it is considered valid to assess the potential for sensitisation on the properties of other lithium salts and on benzoic acid and its soluble salts. Benzoates and benzoic acid is widely used in cosmetics and there is no evidence that this chemical types results in any immune response leading to sensitisation to skin or respiratory system. However, limited animal data is available and some of the Governmental revues performed on benzoates and benzoic acid rely on human trials to make conclusions that there is no potential for sensitisation. There is a similar absence of primary data for lithium salts. Many common lithium salts are irritant or corrosive to skin (alkaline) and the most widely used salt for consumer use is carbonate; however, almost all data found for the carbonate is based on oral exposure as there are no therapeutic uses from dermal administration.
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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