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EC number: 231-439-8 | CAS number: 7550-35-8
- 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
- Study period:
- 1996-10-08 to 1997-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- December 29th 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- November 1984
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before LLNA method was described as OECD test guideline and before it could be established in the EU-REACH Regulation. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 1), this study precludes the need for an additional LLNA study.
Test material
- Reference substance name:
- Lithium bromide
- EC Number:
- 231-439-8
- EC Name:
- Lithium bromide
- Cas Number:
- 7550-35-8
- Molecular formula:
- BrLi
- IUPAC Name:
- lithium bromide
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc., Denver, PA
- Age at study initiation: young adults
- Weight at study initiation: 328-417 g
- Housing: individually housed in suspended polycarbonate cages
- Diet (e.g. ad libitum): Purina Guinea Pig Chow 5025, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64-72
- Humidity (%): 47-78
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 100% (LiBr solution undiluted), three applications
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge: 100% (LiBr solution undiluted)
Rechallenge: 100% (LiBr solution undiluted)
- No. of animals per dose:
- Test group: 10 animals
naive test group: 20 animals (10 animals for challenge, 10 animals for rechallenge) - Details on study design:
- RANGE FINDING TESTS:
On the day prior to the beginning of this phase, four guinea pigs were selected. Hair was shaved from the animals' backs. On the following day, the guinea pigs were dosed by the closed patch method. Four different concentrations (undiluted and 50 %, 25 % and 10 % in tap water) of test material were tested; each concentration was placed onto a Hilltop Chamber™. The chambers were applied to the back of each animal (two on each side) and were held in place with 1 inch Dermicel tape. Each guinea pig was wrapped with an elastic, plastic-lined bandage. At the end of the 6-hour exposure period, the animals were unwrapped, the chambers and bandages were removed, and any residual test material was wiped away with a clean gauze pad moistened with tap water. Approximately 24 hours after unwrapping, the test sites were scored via the Buehler Grading Scale.
MAIN STUDY
A. INDUCTION EXPOSURE
On the day prior to the beginning of the induction phase, the guinea pigs were selected for the study and weighed. The hair was shaved over the right shoulder of each animal designated for induction. The hair was clipped as needed throughout the study.
On day 0, a dose of lithium bromide solution was applied to a Hilltop Chamber™ with a syringe (0.50 mL). Each Hilltop Chamber™ containing the test material was placed on the right shoulder of each animal in the test group and held in place with 1 inch Dermicel tape. Each animal was wrapped with an elastic, plastic-lined bandage. This application was followed by two additional applications, one each on days 7 and 14. The test site was moved during induction to prevent cumulative irritation.
The test material was left in contact with the skin of the right shoulder for approximately six hours. At the end of the exposure period the animals were unwrapped, the Hilltop Chambers™ and bandages were removed, and any residual test material was wiped away with clean gauze moistened with tap water.
B. CHALLENGE EXPOSURE
On day 28, the animals were challenged at a virgin skin site (left shoulder); the animals were dosed by the closed patch method as previously described. Animals in the test and the naive test groups received 0.50 mL of the undiluted test material on the left shoulder.
After approximately six hours the animals were unwrapped, the Hilltop Chambers™ and bandages were removed, and any residual material was wiped away with a clean gauze pad moistened with tap water.
C. RECHALLENGE EXPOSURE
A re-challenge was performed on the test group one week later on day 35. Ten new animals were used to serve as the naive test group. All animals were dosed on a virgin test site on the right flank. The concentration chosen for re-challenge was the highest non-irritating level (undiluted) of the test material. The animals were dosed in the same manner as the challenge application, except the patches were placed on the right flank of each animal. - Challenge controls:
- Naive controls of the challenge and rechallenge exposure remained untreated during the induction phase. During challenge and rechallenge they were treated the same as the test group.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very faint nonconfluent erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% (LiBr undiluted). No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: very faint nonconfluent erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- very faint non confluent erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% (LiBr undiluted). No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: very faint non confluent erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- strong erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% (LiBr undiluted). No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: strong erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- 3 animals with very faint erythema, 2 animals with strong erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% (LiBr undiluted). No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 3 animals with very faint erythema, 2 animals with strong erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% (LiBr undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% (LiBr undiluted). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (LiBr undiluted)
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 1 animal with moderate erythema, 3 animals with strong erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 100% (LiBr undiluted). No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 1 animal with moderate erythema, 3 animals with strong erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (LiBr undiluted in water)
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 1 animal with moderate erythema, 3 animals with strong erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 100% (LiBr undiluted in water). No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 1 animal with moderate erythema, 3 animals with strong erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.4% (w/v) DNCB in 80% ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 9 animals with moderate erythema, 1 animal with strong erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.4% (w/v) DNCB in 80% ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 9 animals with moderate erythema, 1 animal with strong erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.4 % (w/v) DNCB in 80% ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 6 animals with moderate erythema, 4 animals with strong erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.4 % (w/v) DNCB in 80% ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: 6 animals with moderate erythema, 4 animals with strong erythema.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the findings in this guinea pig Buehler test lithium bromide is sensitising to the skin.
- Executive summary:
A guinea pig Buehler test was performed with lithium bromide according to OECD guideline 406 and EU method B.6. Lithium bromide solution (0.50 mL) 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. Fourteen 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 ten male naive animals (naive test group) also received 0.50 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. On day 35 a re-challenge was performed using the original test animals and a new naive test group; the animals received the undiluted test material. Observations for skin reactions were recorded approximately 24 and 48 hours following unwrapping of the re-challenge application. Body weights were recorded at initiation and termination.
All animals remained healthy and gained weight during the study. Three animals in the test group displayed very faint to faint erythema following the first induction; irritation worsened with subsequent inductions. Following challenge of the test group, very faint erythema was noted in 3 males and strong erythema and necrosis were noted in two males. The only irritation noted among naive test animals during challenge was very faint erythema in three guinea pigs. During re-challenge one male in the test group had moderate erythema and 3 males in the test group had strong erythema and necrosis. No irritation was noted among the naive test animals during re-challenge.
Under the conditions of this study, the test material was judged to be sensitising when topically applied to Hartley guinea pigs. (FMC, 1997)
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