Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Assessment has been made based on the well established toxicity profile of benzoate (specifically sodium benzoate) and lithium salts.
Key value for chemical safety assessment
Acute toxicity: via oral route
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 lithium and 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.
Certain lithium salts are corrosive or irritating to skin and dermal toxicity data from such salts are not considered valid for assessment; lithium carbonate is of low irritation and is the main salt for therapeutic use. Acute dermal toxicity results are reports from different sources to be > 2000 mg/kg and the carbonate is not classified.
Benzoic acid and sodium benzoate have also 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
Lithium carbonate, sodium benzoate and benzoic acid have all been extensively reviewed by national and international agencies. Lithium carbonate is the most commonly used form of lithium for medicinal use, in view of good water solubility and low irritancy; some data on organic salts are available and these have been used when appropriate to enhance this assessment.
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.
The US FDA suggest lithium overdose in humans may lead to diarrhoea, vomiting, drowsiness, muscular weakness and lack of coordination.
The LD50 is estimated on the basis that lithium is likely to be the more toxic ion
Using reported oral LD50 for lithium carbonate (500 - 700 mg/kg), the estimated LD50 for lithium element is 50 - 70 mg/kg in rats.
Extrapolating to lithium benzoate suggests that with the presence of approximately 5% by weight lithium, the toxicity of lithium benzoate is estimated 1000 - 1400 mg/kg
No further animal testing is justified and the substance should be classified as Acute Tox 4
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.