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EC number: 233-820-4 | CAS number: 10377-48-7
- 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:
- 1993-10-18 to 1993-11-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- 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. The availabe skin sensitisation study was performed according to OCED guideline 406 and is of good quality (reliability 1). In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
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: HRP, Inc., Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 301 g - 379 g
- Housing: individually housed in suspended polycarbonate cages
- Diet: ad libitum, Purina Guinea Pig Chow 5025
- Water: ad libitum, fresh tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 23.3
- Humidity (%): 37 - 89
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol, acetone
- Concentration / amount:
- Test group: 0.3 g undiluted test material
Positive control group: 0.3 g test material plus 0.3 mL of 0.15 % DNCB in 80 % ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol, acetone
- Concentration / amount:
- Test group: 0.3 g undiluted test material
Positive control group: 0.3 g test material plus 0.3 mL of 0.15 % DNCB in 80 % ethanol
- No. of animals per dose:
- Test group: 20 (10 male, 10 female)
Positive control group: 10 (5 male, 5 female)
Challenge group: 10 (5 male, 5 female) - Details on study design:
- The test material (0.3 g) was applied undiluted to with 20 Hill Top Chambers®. In addition, 0.3 g test material plus 0.3 mL of 0.15 % DNCB in 80 % ethanol was applied to the test sites (left shoulder), and secured with hypoallergenic tape. Each animal was then wrapped with an elastic, plastic-lined bandage.
Six hours later, the bandage and chambers were removed and the test sites were wiped with clean gauze moistened with methanol. The test sites were then rinsed with tap water. The guinea pigs were dosed in this manner once weekly until a total of three applications had been administered. Following a 14-day period, the guinea pigs were challenged on a virgin site on the right shoulder in the manner described above. - Challenge controls:
- Naive controls of the challenge exposure remained untreated during the induction phase. During challenge they were treated the same as the test group.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- Animals in the positive control group had slight erythema and edema following the initial induction application and all but one had well defined to moderate erythema and slight to mild edema following challenge.
No irritation was noted on any of the test or challenge control animals at any time during the study.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3 g test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3 g test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge group
- Dose level:
- 0.3 g test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge group. Dose level: 0.3 g test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 g test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 g test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge group
- Dose level:
- 0.3 g test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge group. Dose level: 0.3 g test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: positive control challenge
- Dose level:
- 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: positive control challenge. Dose level: 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: positive control challenge
- Dose level:
- 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: positive control challenge. Dose level: 0.3 g test substance and 0.3 mL of 0.15 % DNCB in 80 % ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: None.
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The challenge results for erythema are summarized below:
Erythema Scoresa |
||||||||
Group |
|
0 |
1 |
2 |
3 |
4 |
Incidenceb |
Severityc |
Test Material |
(24hr) |
0 |
0 |
0 |
0 |
0 |
0/20 |
0 |
|
(48hr) |
0 |
0 |
0 |
0 |
0 |
0/20 |
0 |
Challenge Control |
(24hr) |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
|
(48hr) |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Positive Control |
(24hr) |
0 |
1 |
1 |
8 |
0 |
9/10 |
2.7 |
|
(48hr) |
0 |
1 |
5 |
4 |
0 |
9/10 |
2.3 |
a: Number animals exhibiting each score.
b: Number animals having scores greater than 1/ Total number animals challenged
c: Sum of (Number animals exhibiting each score x score)/ Total number animals challenged
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the lithium carbonate is not sensitising when topically applied to the intact skin of Hartley guinea pigs.
- Executive summary:
A skin sensitisation test in Hartley guinea pigs was performed according to OECD 406 and EU method B.6 (Buehler test). Lithium carbonate Pharmaceutical Grade (0.30 g) was applied undiluted topically to the left shoulders (previously clipped free of hair) of 10 male and 10 female Hartley guinea pigs. The test material was left in contact with the skin for approximately six hours. The animals received three induction treatments one week apart. A concurrent positive control group of 10 animals was treated in a similar manner with DNCB (0.15 % weight/volume). 14 days after the third induction treatment, the animals were challenged with the test material at a virgin skin site. An additional 5 male and 5 female naive animals received 0.30 g of the undiluted test material (challenge control group). The positive control group was challenged with DNCB. Observations for skin reactions were recorded at initiation and termination. All animals remained healthy and gained weight during the study. No skin reactions were noted on any of the test or challenge control animals at any time during the study. Animals in the positive control group had slight erythema and edema following the initial induction application and all but one had well defined to moderate erythema and slight to mild edema following challenge. Under the conditions of this study, the test material is non-sensitizing when topically applied to Hartley guinea pigs.
Based on the results obtained, lithium carbonate is not sensitising, when topically applied to the intact skin of Hartley guinea pigs.
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