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EC number: 456-990-3 | CAS number: 244761-29-3 LITHIUM-BIS(OXALATO)BORATE
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-10-06 to 2004-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Paris Cedex, April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Mice: inbred, SPF-Quality, nulliparous, non-pregnant
- Vehicle:
- dimethylformamide
- Concentration:
- 2.5 %, 10 % and 25 % and control
- No. of animals per dose:
- 5 female each group
- Details on study design:
- Test substance concentrations selected for the main study were based on the results of a preliminary study:
Irritation: At 50 % erythema (grade 3 with wounds on both ears) were observed on Day 3. There was no irritation with 25 %.
In the main study, three groups of five experimental animals were epidermally exposed to the test material at concentrations of 2.5 %, 10 % and 25 %, respectively on three consecutive days. The dorsum surface of both ears was epidermally treated (25 µl/ear) with the test substance
concentration, at approximately the same time each day.
Five vehicle control animals were similarly treated, but with vehicle alone (N,N-dimethylformamide).
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were done.
Interpretation:
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group.
lf the results indicate a SI >= 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM (NIH publication; No 99-4494, February 1999).
Observations:
Mortality/Viability: Twice daily.
Toxicity: At least once daily.
Body weights: On days 1 (pre-treatment) and 6.
Irritation: On day 3 (3-4 hours after treatment), the skin reactions were assessed. lf possible, skin reactions were graded according to the following numerical scoring system. Furthermore descriptions of all other (local) effects were recorded. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The SI (stimulation indices) values calculated for HCA (Hexyl cinnamic aldehyde) concentrations of 5 %, 10 % and 25 % were 1.0, 3.2 and 7.1, respectively. An EC3 value of 9.5 % was calculated using linear interpolation.
The calculated EC3 value was found to be in the acceptable range of 2 % to 20 %. The results of the 6 monthly reliability checks of the recent years were 8.8, 5.5, 7.3 and 10.3. - Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- 2.5%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM/animal values for the experimental groups treated with the test substance at concentrations of 2.5 %, 10 % and 25 % were 1054, 2423 and 7022, respectively. The mean DPM/animal value for the vehicle control group was 268.
- Parameter:
- SI
- Value:
- 9
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 26.2
- Test group / Remarks:
- 25%
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), lithium bis(oxalato)borate should be regarded as a skin sensitiser.
- Executive summary:
A local lymph node assay was conducted with lithium bis(oxalato)borate according to OECD guideline 429 and EU method B.42. In the main study, three groups of five mice were epidermally exposed to the test substance at concentrations of 2.5 %, 10 % and 25 %, respectively on three consecutive days. Five vehicle control mice were similarly treated, but with vehicle alone (N,N-dimethylformamide). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were done. The sizes of the nodes increased with increasing dose levels. No other macroscopic abnormalities of the nodes were noted. Mean DPM/animal values for the experimental groups treated with test substance concentrations of 2.5 %, 10 % and 25 % were 1054, 2423 and 7022, respectively. The mean DPM/animal value for the vehicle control group was 268. The SI values calculated for the substance concentrations of 2.5 %, 10 % and 25 % were 3.9, 9.0 and 26.2, respectively. This data showed a dose-response and the EC3 value was considered to be below 2.5 %. Based on these results lithium bis(oxalato)borate should be regarded as a skin sensitiser. (NOTOX, 2004)
Reference
This data showed a dose response and the EC3 value was considered to be below 2.5 %.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
The sizes of the nodes increased with increasing dose levels. No other macroscopic abnormalities of the nodes were noted.
Table: Skin reactions after 3rd induction, body weight and relative size nodes (+ = enlarged; n = considered to be normal):
group | Day 1 | Day 3 | Day 6 | |||||
bw | skin grading dorsal surface ear | bw | size nodes | |||||
(g) | left | right | (g) | left | right | |||
erythema | oedema | erythema | oedema | |||||
Vehicle control | 25 | 0 | 0 | 0k | 0 | 24 | n | n |
23 | 0 | 0 | 0 | 0 | 24 | n | n | |
24 | 0k | 0 | 0 | 0 | 25 | n | n | |
23 | 0 | 0 | 0 | 0 | 24 | n | n | |
22 | 0 | 0 | 0 | 0 | 24 | n | n | |
2.5 % test substance | 24 | 0 | 0 | 0 | 0 | 26 | n | n |
23 | 0 | 0 | 0 | 0 | 24 | n | n | |
25 | 0 | 0 | 0 | 0 | 24 | n | n | |
21 | 0 | 0 | 0k | 0 | 22 | n | n | |
21 | 0 | 0 | 0 | 0 | 23 | n | n | |
10 % test substance | 24 | 0 | 0 | 0 | 0 | 25 | n | n |
19 | 0 | 0 | 0 | 0 | 20 | + | + | |
22 | 0 | 0 | 0 | 0 | 20 | + | + | |
24 | 0s | 0 | 0 | 0 | 22 | n | n | |
25 | 0 | 0 | 0 | 0 | 26 | ++ | ++ | |
25 % test substance | 22 | 0 | 0 | 0 | 0 | 22 | ++ | ++ |
24 | 0k | 0 | 0k | 0 | 23 | ++ | ++ | |
22 | 0 | 0 | 0 | 0 | 21 | ++ | ++ | |
24 | 0 | 0 | 0 | 0 | 23 | ++ | ++ | |
24 | 0 | 0 | 0 | 0 | 23 | ++ | ++ |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A local lymph node assay was conducted with lithium bis(oxalato)borate according to OECD guideline 429 and EU method B.42. In the main study, three groups of five mice were epidermally exposed to a 2.5 %, 10 % and 25 % concentration respectively on three consecutive days. Five vehicle control mice were similarly treated, but with vehicle alone (N,N-dimethylformamide). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were done. The sizes on the nodes increased with increasing dose levels. No other macroscopic abnormalities of the nodes were noted. Mean DPM/animal values for the experimental groups treated with test substance concentrations 2.5, 10 and 25 % were 1054, 2423 and 7022 respectively. The mean DPM/animal value for the vehicle control group was 268. The SI (stimulation index) values calculated for the substance concentrations 2.5 %, 10 % and 25 % were 3.9, 9.0 and 26.2, respectively. This data showed a dose-response and the EC3 value was considered to be below 2.5 %. Based on these results lithium bis(oxalato)borate should be regarded as a skin sensitiser. (NOTOX, 2004)
Short description of key information:
Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), lithium bis(oxalato)borate should be regarded as a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study.
Justification for classification or non-classification
Based on the available data on sensitisation LiBOB should be classified and labelled as sensitising to the skin (R43) according to Directive 67/548/EEC (DSD) and as may cause an allergic skin reaction (H317), category 1 according to Regulation (EC) No 1272/2008 (CLP).
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