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EC number: 234-514-3 | CAS number: 12007-60-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11th December 2017 to 28th December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Dilithium tetraborate
- EC Number:
- 234-514-3
- EC Name:
- Dilithium tetraborate
- Cas Number:
- 12007-60-2
- Molecular formula:
- B4Li2O7
- IUPAC Name:
- dilithium tetraborate
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 20 to 21°C with an actual daily mean relative humidity of 43 to 50%. A 12 hour light/12 hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on dermal exposure:
- A single dose of test item was administered to the appropriate animals by dermal application on Day 1. One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total body surface, i.e. approximately 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only. The application period was 24 hours, after which the dressing was removed and the skin cleaned of residual test item using water.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg (bw)
- No. of animals per sex per dose:
- 5 males and 5 females (females were nulliparous and non-pregnant).
- Control animals:
- no
- Details on study design:
- Dilithium tetraborate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Red discoloration of the nose was noted for one male and one female on Days 1 and/or 2 and chromodacryorrhoea of the snout was noted for two males and on female on Day 2.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
TABLE 1 MORTALITY DATA |
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MALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
FEMALES 2000 MG/KG |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
TABLE 2 CLINICAL SIGNS |
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ANIMAL 1 |
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Secretion / excretion |
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. |
Chromodacryorrhoea (Snout) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 2 |
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Skin / fur |
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Red discolouration (Nose) |
(1) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 3 |
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Secretion / excretion |
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Chromodacryorrhoea (Snout) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 4 |
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No clinical signs noted |
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- |
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- |
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- |
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. |
ANIMAL 5 |
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No clinical signs noted |
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ANIMAL 6 |
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Skin / fur |
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General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
Scales (Treated skin) |
(3) |
- |
- |
- |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
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- |
- |
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. |
ANIMAL 7 |
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Skin / fur |
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General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
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- |
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- |
- |
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. |
ANIMAL 8 |
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Skin / fur |
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General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
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- |
- |
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Red discolouration (Nose) |
(1) |
- |
1 |
1 |
- |
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- |
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ANIMAL 9 |
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Skin / fur |
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General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
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- |
- |
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ANIMAL 10 |
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Skin / fur |
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General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
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Secretion / excretion |
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Chromodacryorrhoea (Snout) |
(3) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
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- = Sign not observed |
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TABLE 3: MACROSCOPIC FINDINGS
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MALES 2000 MG/KG |
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1 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
2 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
3 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
4 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
5 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
FEMALES 2000 MG/KG |
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6 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
7 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
8 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
9 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
10 |
No findings noted |
Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Dilithium tetraborate in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, dilithium tetraborate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
- Executive summary:
Dilithium tetraborate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No deaths or abnormalities were found at macroscopic post mortem examination of the animals. Based on these results, dilithium tetraborate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
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.