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EC number: 234-541-0 | CAS number: 12008-41-2
- 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
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- Nanomaterial pour density
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- 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
Acute oral, dermal and inhalation toxicity studies have been performed with disodium octaborate tetrahydrate. Experimental data showed low acute toxicity to disodium octaborate tetrahydrate. The mean of the male and female values were obtained from the key study (oral route; Doyle 1988). The LD50 (oral) is equivalent to 534.5 mg B/kg bw.
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
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Approved USDA source
- Weight at study initiation: Males 262 –371g; Females 226 –275 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % w/v - Doses:
- 1.25; 2.0; 3.15; 5.0 g/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs and body weight - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 550 mg/kg bw
- 95% CL:
- >= 2.1 - <= 3.1
- Remarks on result:
- other: According to the method of Litchfield and Wilcoxon
- Mortality:
- At 5.0 g/kg ten deaths occurred between days 0 and 2 of the observation period.
At 3.15 g/kg six deaths occurred between days 1 and 3 of the observation period.
At 2.0 g/kg four deaths occurred on day 1 of the observation period.
At 1.25 g/kg there were no deaths. - Clinical signs:
- other: At 5.0 g/kg the following clinical changes were observed: Mild to extreme depression, fecal stains, loose mucoid faeces on cage paper, urine stains, piloerection, eye squinting and scruffy hair coats. At 3.15 g/kg the following clinical changes were obser
- Gross pathology:
- Pathological changes in the animals that died included darkened, reddened pale and/or mottled lungs; congested, mottled or pale kidneys, mottled and/or pale liver and spleens; pale intestines filled with clear yellow liquid; pale pancreas and green watery fluid in stomach and partially distended stomach which reduced in severity with reducing dose
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The acute oral LD50 for males and females was 2550 mg/kg bw.
- Executive summary:
The test item disodium octaborate tetrahydrate was assessed for oral acute toxicity in rats in a GLP study according to OECD Guideline 401. Five animals per sex per dose were exposed via gavage to doses of the test item (50% in water) of 1.25; 2.0; 3.15 and 5.0 g/kg bw. The acute oral LD50 for males and females was 2550 mg/kg bw.
Reference
Cumulative mortality data for male and female rats treated orally with 20 MULE TEAM TIM-BOR:
Dosage (g/kg) |
Cumulative No. of deathsa |
||||||||
Observationsb |
Observations day after treatment |
||||||||
A |
B |
C |
1 |
2 |
3 |
4 |
7 |
14 |
|
Males |
|||||||||
5.0 |
0 |
0 |
0 |
3 |
5 |
5 |
5 |
5 |
5 |
3.15 |
0 |
0 |
0 |
1 |
2 |
4 |
4 |
4 |
4 |
2.0 |
0 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
1.25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Females |
|||||||||
5.0 |
0 |
0 |
2 |
5 |
5 |
5 |
5 |
5 |
5 |
3.15 |
0 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
2.0 |
0 |
0 |
0 |
2 |
2 |
2 |
2 |
2 |
2 |
1.25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
a Five animals per dose per group.
b A = 1 3/4 - 2 h; B = 3 1/4 - 5 3/4 h; C = 6 - 6 3/4 h.
Body weight gain in male and female rats terated orally with 20 MULE TEAM TIM-BOR:
Animal No. |
Sex |
Body weight gain (g) Day 0 - 14 |
0.5 g/kg group |
||
1-7675 |
M |
ND |
2-7686 |
M |
ND |
3-7700 |
M |
ND |
4-* |
M |
ND |
5-* |
M |
ND |
6-7734 |
F |
ND |
7-7737 |
F |
ND |
8-7753 |
F |
ND |
9-7763 |
F |
ND |
10-* |
F |
ND |
3.15 g/kg group |
||
1-7683 |
M |
ND |
2-7688 |
M |
ND |
3-* |
M |
69 |
4-* |
M |
ND |
5-* |
M |
ND |
Mean (S.D.) |
69 |
|
6-7730 |
F |
74 |
7-7736 |
F |
21 |
8-7744 |
F |
ND |
9-4449 |
F |
38 |
10-* |
F |
ND |
Mean (S.D.) |
44 (27) |
|
2.0 g/kg group |
||
1-7695 |
M |
48 |
2-* |
M |
89 |
3-* |
M |
ND |
4-*- |
M |
101 |
5-* |
M |
ND |
Mean (S.D.) |
79 (28) |
|
6-7741 |
F |
43 |
7-7751-D |
F |
ND |
8-7752 |
F |
54 |
9-* |
F |
ND |
10-* |
F |
39 |
Mean (S.D.) |
45 (8) |
|
1.25 g/kg group |
||
1-7684 |
M |
78 |
2-* |
M |
125 |
3-* |
M |
85 |
4-* |
M |
82 |
5-* |
M |
82 |
Mean (S.D.) |
90 (20) |
|
6-7729 |
F |
34 |
7-7756 |
F |
55 |
8-* |
F |
47 |
9-* |
F |
45 |
10-* |
F |
40 |
Mean (S.D.) |
44 (8) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 550 mg/kg bw
- Quality of whole database:
- High quality (Guideline study).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Age at study initiation: Young adult
- Weight at study initiation: Males 224-260 g; females 207 -234 g - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no data
- Details on inhalation exposure:
- TEST ATMOSPHERE
- Particle size distribution: Not an aerosol study
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 2.8 µm + GSD 2.15 µm
- Rationale for the selection of the starting concentration: Top dose ~ 2 mg/L was the highest that was obtainable under the conditions of the test - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- No further details
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration 2000 mg/m³
Analytical concentration 2010 ± 140 mg/m³ - No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- - Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.01 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No data
- Clinical signs:
- other: Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During exposure, ocular discharge, hypoactivity and haunched posture were noted. All animals recovered after removal from chamber.
- Body weight:
- See table
- Gross pathology:
- No specific findings observed except red lung discolouration consistent with CO2 inhalation (caused by euthanasia technique). All tissue sand organs were normal.
- Other findings:
- No data
- Interpretation of results:
- other: EU GHS Criteria not met
- Conclusions:
- The sample was ground in a ball mill for 24 hours to give a MMAD 2.8 µm + GSD 2.15 µm
Top dose ~ 2 mg/L was the highest that was obtainable under the conditions of the test. The acute inhalation LC50 was > 2.01 mg/L (2.01 g/m³). - Executive summary:
The test item disodium octaborate tetrahydrate was assessed for inhalation acute toxicity in rats in a GLP study according to OECD Guideline 403. Five animals per sex per dose were exposed per whole body to a maximum attainable test item concentration of 2.01 mg/L for 4 hours. The acute inhalation LC50 was > 2.01 mg/L (2.01 g/m³).
Reference
Gravimetric chamber concentrations:
Sample No. |
Mass collected (mg) |
Airflow sampled (Lpm) |
Collection time (min) |
Chamber concentration (mg/L) |
1 |
14.5 |
4 |
2 |
1.81 |
2 |
19.1 |
4 |
2 |
2.38 |
3 |
15.4 |
4 |
2 |
1.93 |
4 |
17.5 |
4 |
2 |
2.19 |
5 |
17.1 |
4 |
2 |
2.14 |
6 |
14.6 |
4 |
2 |
1.83 |
7 |
14.4 |
4 |
2 |
1.80 |
Average ± Standard deviation |
2.01 ± 0.23 |
Summary of particle size distribution:
Sample No. |
Sampling time (min) |
Mass mean aerodynamics diameter (μm)1 |
Geometric standard deviation |
1 |
2 |
2.7 |
2.08 |
2 |
2 |
2.8 |
2.15 |
1 This figure is an estimation based on graphic analysis of the particle size distribution as measured with an Andersen Cascade Impactor
Individual body weights:
Animal No. |
Sex |
Body weight (g) |
||
Initial |
Day 7 |
Day 14 |
||
5409 |
M |
224 |
338 |
376 |
5410 |
M |
256 |
332 |
374 |
5411 |
M |
224 |
303 |
351 |
5412 |
M |
260 |
340 |
392 |
5413 |
M |
225 |
296 |
329 |
5414 |
F |
207 |
232 |
240 |
5415 |
F |
215 |
223 |
231 |
5416 |
F |
215 |
235 |
249 |
5417 |
F |
234 |
250 |
253 |
5418 |
F |
207 |
222 |
233 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 010 mg/m³ air
- Quality of whole database:
- High quality (Guideline study).
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:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 158, 162); TSCA (40 CFR 798)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Clerco Research Farm
- Weight at study initiation: Males: 2720 -3379 g; females: 2699 –3057 g - Type of coverage:
- semiocclusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: No data
- % coverage: Not specified but implies > 10 % of body surface
- Type of wrap if used: Semi occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moist towel
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dosage to 2 g/kg bw - Duration of exposure:
- 24 h
- Doses:
- Dosage to 2 g/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No data
- Other examinations performed: Clinical signs and histopathology - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No lethal effect at limit dose
- Clinical signs:
- other: No clinical changes were observed
- Gross pathology:
- No gross necropsy findings were observed.
- Other findings:
- No data
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- The acute dermal LD50 was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.
- Executive summary:
The test item disodium octaborate tetrahydrate was assessed for dermal acute toxicity in rabbits in a GLP study according to OECD Guideline 402. Five animals per sex per dose were exposed via gavage to a single dose of the test item of 2.0 g/kg bw. The acute dermal LD50 for males and females was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality (Guideline study).
Additional information
LD50 values of >2000 mg/kg were recorded for both oral and dermal routes and > 2 mg/L for the acute inhalation study with disodium octaborate tetrahydrate. The inhalation figure represents the highest attainable concentration.
Disodium octaborate tetrahydrate is of low acute toxicity.
No information is available on the acute toxicity of disodium octaborate anhydrate.
Using read-across from disodium octaborate tetrahydrate with a correction for the difference in molecular weight is considered correct because no differences in uptake are expected and once taken up the effects will not significantly differ. This correction for differences in molecular weight results in an LD50 of 2105 mg/kg bw for disodium octaborate anhydrate. For acute dermal and inhalation toxicity also no mortality is expected at the limit dose (dermal) or the highest attainable dose (inhalation, LC50 > 1.65 mg/L). It is expected that the toxicity of disodium octaborate anhydrate and disodium octaborate tetrahydrate will be similar and that both substances do not need to be classified for acute oral, dermal and inhalation toxicity
Justification for classification or non-classification
Disodium octaborate tetrahydrate is not classified for the oral, dermal or inhalation route, as the LD50 values exceed the limit for classification according to Regulation (EC) No 1272/2008 (CLP Regulation).
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