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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-102-5 | CAS number: 7439-93-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-12-23 to 1998-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid skin sensitisation study according to OECD guideline 406 with lithium chloride is available.
Test material
- Reference substance name:
- Lithium chloride
- EC Number:
- 231-212-3
- EC Name:
- Lithium chloride
- Cas Number:
- 7447-41-8
- Molecular formula:
- ClLi
- IUPAC Name:
- Lithium chloride
- Details on test material:
- - Name of test material (as cited in study report): Lithium chloride solution
- Physical state: Clear liquid
- Analytical purity: 40.8 % (Specification: 38 - 42 %)
- Composition of test material, percentage of components: 35 - 40 % LiCl, aqueous solution
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Covance, Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 301 g - 379 g
- Housing: individually housed in suspended polycarbonate cages
- Diet (e.g. ad libitum): ad libitum, Purina Guinea Pig Chow 5025
- Water (e.g. ad libitum): ad libitum, fresh tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9°C - 20°C
- Humidity (%): 32 % - 53 %
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- undiluted, 0.5 mL
- Day(s)/duration:
- 0-14 d/ 6h
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- undiluted, 0.5 mL
- Day(s)/duration:
- day 28/ 6h
- No. of animals per dose:
- Irritation Range-Finding Phase: 4
Induction and Challenge:
Test Group: 10
Naive Test Group: 10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL undiluted test material
- Control group: -
- Site: right shoulder
- Frequency of applications: day 0, 7 and 14
- Duration: 0-14 d
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 h
- Test groups: 0.5 mL undiluted test material
- Control group: 0.5 mL undiluted test material
- Site: left shoulder
- Evaluation (hr after challenge): 6 h
- Challenge controls:
- No challenge controls
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL undiluted
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema, usually nonconfluent
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL undiluted
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Very faint erythema, usually nonconfluent
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Group:
- positive control
- Remarks on result:
- other: not indicated
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of this study (Buehler test), the test material, lithium chloride revealed no sensitizing properties. Based on this result, it can be assumed that lithium is not sensitizing.
- Executive summary:
In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.3. an in vivo sensitisation test does not need to be conducted if the available information indicates that the substance should be or is classified as corrosive to the skin. Lithium metal is corrosive and is labelled as such as it forms a strong base (lithium hydroxide) in contact with water or moist skin. Thus, results of a sensitisation study with lithium metal will be of no meaningful value because of local tissue damage due to corrosiveness. For estimation of the sensitisation potential of lithium / lithium ions a study with lithium chloride was used in a read-across approach.
As skin sensitisation study with lithium is not available, read-across was applied using study results obtained from lithium chloride.
A skin sensitisation test in Hartley guinea pigs was performed according to OECD 406 and EU method B.6. lithium chloride solution (0.5 mL undiluted) was applied to the right shoulder of each of ten male Hartley guinea pigs for a six hour exposure period at weekly intervals for three weeks. 14 days after the third induction treatment, the animals were challenged at a virgin skin site. The concentration of the test material chosen for challenge of the test group was the undiluted test material, which was the highest non-irritating concentration as determined during the range-finding phase of this study. An additional 10 male naive animals (naive test group) also received 0.5 mL of the undiluted test material for the challenge application. Observations for skin reactions were recorded approximately 24 hours after unwrapping each induction application and approximately 24 and 48 hours following unwrapping of the challenge application. Body weights were recorded at initiation and termination.
All animals remained healthy and gained weight during the study. No irritation was noted on animals in the test group following the first induction. Cumulative irritation was noted during successive inductions resulting in very faint to strong erythema. No evidence of sensitization occurred; three test of the test group animals displayed very faint erythema following challenge. Four animals in the challenge control group displayed very faint erythema during challenge. Because reactions were comparable between treated and naive animals at challenge, responses noted were attributed to irritation rather than sensitization reactions. Under the condition of this study, the test material lithium chloride is judged to be non-sensitizing when topically applied to Hartley guinea pigs.
Based on the results obtained in this study and following a read across approach, it can be assumed that lithium is not sensitising and has not to be classified and labelled with respect to skin sensitisation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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.