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Diss Factsheets
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EC number: 203-698-7 | CAS number: 109-72-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1997-12-23 to 1998-03-30
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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
Test material
- Reference substance name:
- Lithium chloride
- EC Number:
- 231-212-3
- EC Name:
- Lithium chloride
- Cas Number:
- 7447-41-8
- 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 %)
- Lot/batch No.: 410-01d
- Composition of test material, percentage of components: 35 - 40 % LiCl, aqueous solution
- Stability under test conditions: not available
- Storage condition of test material: Room temperature
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)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Irritation Range-Finding Phase: undiluted, 50 %, 25 % and 10 % in tap water
Induction Phase: undiluted, 0.5 mL
Challenge Phase: undiluted, 0.5 mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Irritation Range-Finding Phase: undiluted, 50 %, 25 % and 10 % in tap water
Induction Phase: undiluted, 0.5 mL
Challenge Phase: undiluted, 0.5 mL
- 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
- 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL undiluted. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Very faint erythema, usually nonconfluent.
- 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
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- 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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 mL undiluted. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Very faint erythema, usually nonconfluent.
- 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
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 mL undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the condition of this study (Buehler test with Lithium chloride), the test material is judged to be non-sensitizing when topically applied to Hartley guinea pigs. Based on this result, it can be assumed that n-Butyl lithium is not a sensitizer.
- Executive summary:
Studies to determine the animal toxicity cannot be performed with n-Butyl lithium because of its reactivity and corrosive properties. n-Butyl lithium is pyrophoric and would react violently on exposure to animal tissues, releasing flammable butane and corrosive lithium hydroxide, and likely starting a fire.
In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.3. an in vivo test does not need to be conducted if the available information indicates that the substance should be classified for skin corrosivity, or the substance is a base (pH ≥ 11,5), or the substance is flammable in air at room temperature.
Instead, a study with lithium chloride was used for read-across.
An skin sensitisation test in Hartley guinea pigs was performed according to OECD Guideline 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 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 is judged to be non-sensitizing when topically applied to Hartley guinea pigs.
Based on this result, it can be assumed that n-Butyl lithium is not a sensitizer.
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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