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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
Endpoint summary
Administrative data
Description of key information
The oral LD50 value of dilithium tetraborate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Specific details on test material used for the study:
- Test item storage: At room temperature
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Sex: 9 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
- Age at study initiation: Young adult animals (approximately 10-11 weeks old) were selected.
- Weight at study initiation: 165 to 200 g.
- Housing: polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum
- Water: Municipal tap-water was freely available
- Acclimation period: At least 5 days before dosing.
- Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
ENVIRONMENTAL CONDITIONS
- 18 to 24°C with a relative target humidity of 40 to 70% - Route of administration:
- oral: gavage
- Vehicle:
- other: medicinal white oil
- Details on oral exposure:
- VEHICLE
- Identification: MOL WO M46 medicinal white oil
- Justification for choice of vehicle: The vehicle was selected based on information provided by the Sponsor
- Lot/batch no. (if required): 208885/A
- Specific gravity: 0.833-0.893 g/cm3 (at 15°C)
A dose volume of 10 mL/kg body weight was used for each dose.
The oral route was selected as it is a possible route of human exposure during manufacture, handling or use of the test item.
The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. - Doses:
- The first group was treated at a dose level of 2000 mg/kg. Based on the results, two additional groups were dosed at 300 mg/kg.
- No. of animals per sex per dose:
- 3 Females per dose group.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Postdoes observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. All the animals were examined for reaction to dosing and the onset,intensity and duration of these signs were recorded.
- All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
- The body weights of the animals were recorded individually on Day 1 (predose), 8 and 15. - Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, all animals were found dead on Day 2. At 300 mg/kg, no mortality occurred.
- Clinical signs:
- other: Hunched posture, uncoordinated movements, piloerection and ptosis were noted for all animals on Day 1 at 2000 mg/kg. At 300 mg/kg, hunched posture, uncoordinated movements and piloerection were noted for all animals between Days 1 and 2.
- Gross pathology:
- Abnormalities of the stomach (gelatinous contents and/or dark red/discoloured/thickened glandular mucosa) were found in the animals that died during the study, at macroscopic post mortem examination. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The oral LD50 value of dilithium tetraborate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
- Executive summary:
The potential toxicity of dilithium tetraborate was investigated by administration of a single dose of the test substance by oral gavage to female rats according to OECD 423. Initially, Dilithium tetraborate was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. At 2000 mg/kg, all animals were found dead on Day 2. Two additional groups were dosed at 300 mg/kg body weight. At this dose level, no mortalities were observed but effects including hunched posture, uncoordinated movements and piloerection were noted for all animals between Days 1 and 2. For both dose levels, the body weight gain of the surviving animals was shown to be normal over the study period.
The oral LD50 value of dilithium tetraborate in Wistar rats was therefore established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
- 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.
- 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).
- 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.
- 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).
Reference
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 |
|
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 5 |
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. |
No clinical signs noted |
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- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
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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 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 7 |
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. |
Skin / fur |
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. |
General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 8 |
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. |
Skin / fur |
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. |
General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
Red discolouration (Nose) |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 9 |
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. |
Skin / fur |
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. |
General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
ANIMAL 10 |
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. |
Skin / fur |
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. |
General erythema (Treated skin) |
(4) |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
. |
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
On the basis of the acute toxicity by the oral route study, dilithium tetraborate is classified as Category 4, H302: Harmful if swallowed.
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.