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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 5 treatments during gestation
- 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 in biological systems, it is considered valid to assess separately lithium and benzoate ions
Data source
Reference
- Reference Type:
- publication
- Title:
- EVIDENCE ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY OF Bromacil Lithium Salt
- Author:
- Reproductive and Cancer Hazard Assessment Section Office of Environmental Health Hazard Assessment California Environmental Protection Agency
- Year:
- 2 003
- Bibliographic source:
- Reproductive and Cancer Hazard Assessment Section Office of Environmental Health Hazard Assessment California Environmental Protection Agency 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Mated female CD-1 mice were treated with lithium carbonate by gavage at 0 or 400 mg/kg/d for gestation day 8-12. Mice were allowed to give birth and nurse to postnatal day 3. There were 30 control females, and 25 in each lithium carbonate group. Two types of lithium formulation were administered.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Lithium carbonate
- EC Number:
- 209-062-5
- EC Name:
- Lithium carbonate
- Cas Number:
- 554-13-2
- Molecular formula:
- CH2O3.2Li
- IUPAC Name:
- dilithium carbonate
Constituent 1
- Specific details on test material used for the study:
- There were two lithium carbonate groups: one in which the lithium carbonate suspension was treated with a “Polytron” (presumably sonicated), the other not.
Test animals
- Species:
- mouse
- Strain:
- CD-1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Not specified; treatment started post-mating
- Duration of treatment / exposure:
- Gestation days 8 - 12
- Duration of test:
- Terminated Day 3 postnatal
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day
- Remarks:
- As Lithium carbonate
- No. of animals per sex per dose:
- 50 treated with lithium carbonate; two types of formulation applied, with 25 in each group (one being an emulsion to mimic theraputic deliver methods)
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Yes
- Fetal examinations:
- Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- In the control group, 12 out of 30 animals were pregnant, with two maternal deaths reported. Of the treated group, 33 out of 50 animals were pregnant, with no maternal mortality and all giving birth
- Details on maternal toxic effects:
- No treatment related toxicity
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Mean weight of treated group 1.81 - 1.83 g; control weights 1.69 g
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Pups from treated mothers showed slightly higher growth than control group. - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Apparant reduction in numbers of pups born in one of the treated groups, but pup weight and viabilty unchanged
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- Slight reduction in litter size in one of the treated groups. Reported as statistically significant, but group size two small to make firm conclusionTaking bother treated groups as a whole, no significant effects
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Only a summary report, but used by California State EPA as part of assessment of pesticide review
Applicant's summary and conclusion
- Conclusions:
- At 400 mg/kg/day, no adverse maternal or developmental toxicity observed.
- Executive summary:
Only a summary report, but used by California State EPA as part of assessment of pesticide review
Chernoff N, Kavlock RJ (1982). An in vivo teratology screen utilizing pregnant mice. J Toxicol Environ Health 10(4-5):541-50.
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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