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EC number: - | CAS number: -
- 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
Acute oral, dermal and inhalation studies have been performed with boric acid. Experimental data showed low acute toxicity to boric acid. The mean of the male and female values were obtained from the key study (oral route; Keller 1962). The LD50 is equivalent to 658.9 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not specified
- Principles of method if other than guideline:
- Boric acid was administered orally by gavage to six groups of five male and five female albino Sprague-Dawley rats. The test material was administered as a 50 % w/v suspension in 0.5 % aqueous methyl cellulose at dosage levels of 2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw. Rats were fasted for a period of 3 to 4 h prior to dosage. Animals were observed for mortality and toxic effects at 1, 2, 4, and 24 h and once daily after for a total of 14 days. At teh end of the observation period the surviving animals were weighed sacrificed and autopsies were performed.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- 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
- Weight at study initiation: Males: 267 - 302 g; Females: 214 - 248 g - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % w/v
MAXIMUM DOSE VOLUME APPLIED: 3450 - 4080 mg/kg bw - Doses:
- 2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw.
- No. of animals per sex per dose:
- Five animals/group; no further data
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs - Statistics:
- Litchfield and Wilcoxon
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 450 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 950 - 4 040
- Remarks on result:
- other: mg boric acid/kg
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 080 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 640 - 4 560
- Remarks on result:
- other: mg boric acid/kg bw
- Mortality:
- No data
- Clinical signs:
- other: Symptoms include sings of CNS depression, ataxia, convulsions, laboured breathing or rapid respiration; blood crust around nose, marked diarrhoea and ptosis.
- Gross pathology:
- Autopsies indicated congestion of lungs, kidneys and adrenals; inflammation of the pyloric portion of stomach and small intestine.
- Other findings:
- No data
- Interpretation of results:
- other: no data
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The acute oral LD50 of boric acid for male albino rats was 3450 (2950 - 4040) mg boric acid/kg, equivalent to 604 mg B/kg bw. In female albino rats the acute oral LD50 of boric acid was 4080 (3640 - 4560) mg boric acid/kg, equivalent to 714 mg B/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 765 mg/kg bw
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:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA FIFRA 40 CFR Part 160
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute 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: Ace Animlas Inc, Boyertown, PA
- Age at study initiation: Young adult
- Weight at study initiation: Males 205 - 255 g, females 179 - 208 g - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 3.5 μm ± GSD 1.81 μm
CLASS METHOD
- Rationale for the selection of the starting concentration: ~ 2mg/L was the highest that was obtainable under the conditions of the test. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 2000 mg/m3
Analytical concentration: 2120 ± 140 mg/m3 - 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: Yes
- Other examinations performed: Clinical signs - Statistics:
- Not applicable - limit test
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.12 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: This study was carried out at the request of the US EPA to confirm that the highest dose obtainable was 2 mg/L. It was deemed by the US EPA to be an acceptable study.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: Animal observations were limited to the accumulation of test material on the walls of the exposure chamber. During the first 1.5 h of exposure, ocular and nasal discharge, hypoactivity and hunched posture were noted. Ocular discharge and/or nasal discha
- Body weight:
- No data
- Gross pathology:
- No specific findings observed, except red lung discolouration consistent with carbon dioxide inhalation caused by the euthanisation technique. All tissues and organs were normal.
- Other findings:
- No data
- Interpretation of results:
- other: No data
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The test was performed according to OECD Guideline 403. No deaths occurred. Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During the first 1.5 h of exposure, ocular and nasal discharge, hypoactivity and hunched posture were noted. Ocular discharge and/or nasal discharge persisted in most animals after removal from the chamber. All animals recovered by day two after removal from the chamber.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 mg/m³ air
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:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (40 CFR 163)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan F. Plummer
- Weight at study initiation: 1623 - 2922 g - Type of coverage:
- semiocclusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The skin of all animals was abraded longitudinally every 2 - 3 cm, deep enough to penetrate the stratum corneum, but not cause bleeding.
- % coverage: > 10 % of body surface implied
- 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
- For solids, paste formed: Yes
VEHICLE
- Amount applied: Substance moistened with 1.5 mL saline - Duration of exposure:
- 24 h
- Doses:
- Dosage to 2 g/kg
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, histopathology - Statistics:
- Not applicable - limit test.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: Clinical changes were limited to transient diarrhoea in 2 rabbits and some incidences of erythema (9), and oedema (30), atonia (2), desquamation (4), necrosis, and other evidence of irritation at 23 and ~70.5 h after treatment.
- Gross pathology:
- No gross necrospy findings were observed. Observations included one animal with gas filled intestine, one animal with pale yellow-coloured kidneys and 5 animals with enlarged or swollen fallopian tubes.
- Other findings:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was performed according to FIFRA (40 CFR 163). The LD50 > 2000 mg/kg bw indicating no acute dermal toxicity. No deaths occurred. Clinical changes were limited to erythema, oedema, atonia, desquamation, necrosis and some incidences of skin irritation at more than 24 h of treatment.
Reference
Gross necropsy findings in male and female rabbits at the end of the observation period:
Gross Necropsy Findings |
Dosage at 2 g/kg |
Number of animals necropsied |
10 |
No gross necropsy findings |
5 |
Intestine |
|
Gas-filled |
1 |
Kidneys |
|
Pale yellow coloured |
1 |
Fallopian tubes |
|
Enlarged or swollen |
4 |
Pale |
1 |
External |
|
Diarrhoea stains |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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. The highest attainable inhalation concentration was 2.12 mg/L.
Boric acid is of low acute toxicity. Although some of the acute oral studies were not of modern standards and were performed prior to the introduction of GLP, they are reproducible across a number of studies and species and of acceptable quality. For acute dermal and acute inhalation some studies do meet the modern GLP standard.
Justification for selection of acute toxicity – oral endpoint
Acute toxicity studies are not available for orthoboric acid, potassium salt. Boric acid is used for read-across.
Justification for selection of acute toxicity – inhalation endpoint
Acute toxicity studies are not available for orthoboric acid, potassium salt. Boric acid is used for read-across.
Justification for selection of acute toxicity – dermal endpoint
Acute toxicity studies are not available for orthoboric acid, potassium salt. Boric acid is used for read-across.
Justification for classification or non-classification
Orthoboric acid, potassium salt is not classified for the oral, dermal or inhalation routes, as the LD50 values from read across studies with boric acid exceed the limit for classification.
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.
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