Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-224-5 | CAS number: 13701-64-9
- 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
Numerous studies have demonstrated the toxicokinetics of boric acid and borate salts in humans and experimental animals. At physiological pHs in the aqueous layer of mucosal surfaces, prior to absorption, simple inorganic borated salts are hydrolysed to undissociated boric acid, which are readily absorbed via oral and inhalation exposure. Boric acid is not expected to hydrolyse/react further due to the high energy required to break the B – O bond. Therefore, it is expected that there will be negligible parent compound, calcium metaborate, available systemically and boric acid will be the dominant and common compound in humans and experimental animals. Therefore, a read-across approach using boric acid data is considered appropriate to use, refer to Section 13.
According to an OECD Guideline 401 (Acute Oral Toxicity) in male rats an oral LD50 value for the source substance, anhydrous boric acid, was established >2600 mg/kg bw. According to a standard acute oral study method, conducted pre-GLP, the LD50 values of boric acid in male and female albino rats were 3450 and 4080 mg/kg bw, respectively, the mean LD50 was 3765 mg/kg bw.
According to a FIFRA (40 CFR 163) acute dermal study in male and female New Zealand White rabbits a dermal LD50 value for the source substance, boric acid, was established >2000 mg/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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: There were no deaths at this dose level.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single oral administration of anhydrous boric acid to groups of five fasted rats at dose levels of 1540 or 2600 mg/kg resulted in no deaths. The acute median lethal oral dose was therefore considered to be greater than 2000 mg/kg bw.
- 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:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD.BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Age at study initiation: 5 - 8 weeks of age
- Weight at study initiation: 142 - 217 g
- Housing: Up to 5 rats were accommodated in suspended stainless steel mesh cages (dimensions 55 x 34 x 20 cm). The cages were suspended over carboard lined trays for collection of excreta. The liners were replaced at least twice weekly.
- Diet: Ad libitum except during fasting period
- Water: Ad libitum
- Fasting period before study: 18 h prior to dosing until 3 h after dosing
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 C
- Humidity (%): 40 - 70 % relative humidity
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 dark/light; typically 0600 to 1800 h. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: 1132
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: All formulations were used on the day of preparation. - Doses:
- 1540 and 2600 mg/kg
- No. of animals per sex per dose:
- 5 males per dose
- Control animals:
- no
- Details on study design:
- No data
- Statistics:
- No data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: There were no deaths at this dose level.
- Mortality:
- No animal died following administration.
- Clinical signs:
- other: No clinical signs were observed for animals dosed at 1540 mg/kg. Piloerection was apparent from approximately 15 min after dosing and for the remainder of Day 1, for all 5 males dosed at 2600 mg/kg. Two rats were lethargic three hours after dosing and on
- Gross pathology:
- No macroscopic changes were observed during necropsy of Day 15 for animals at 2600 mg/kg.
Isolated changes seen in two rats dosed at 1540 mg/kg included a few red foci on the thymus (animals no 677) and pale lungs and distension of the jejunum (animal No. 678). - Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single oral administration of anhydrous boric acid to groups of five fasted rats at dose levels of 1540 or 2600 mg/kg resulted in no deaths. The acute median lethal oral dose was therefore considered to be greater than 2000 mg/kg bw.
Based on the results of this study, the general Classification and Labelling Requirements for Dangerous Substances and Preparations, as stated in Annex IV to Commission Directive 93/21/EC, indicate that no risk phrase is required for anhydrous boric acid in respect of its acute oral toxicity. - Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 080 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 640 - <= 4 560
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 450 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 950 - <= 4 040
- Interpretation of results:
- GHS criteria not met
- 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.
- 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:
- no guideline followed
- 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 the 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:
- GHS criteria not met
- 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.
Referenceopen allclose all
Clinical signs following treatment at dose level 2600 mg/kg:
Clinical sign |
Animal No. |
Time of first observation |
Time of recovery |
||||
675 M |
658 M |
659 M |
660 M |
661 M |
|||
Pilo-erection |
+ |
+ |
+ |
+ |
+ |
0.25 h |
Day 2 |
Lethargy |
- |
+ |
- |
+ |
- |
3 h |
Day 2 |
Tachypnoea |
- |
+ |
- |
- |
- |
3 h |
Day 2 |
+/- = sign present or absent
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 765 mg/kg bw
- Quality of whole database:
- The read-across study is reliable with restrictions
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- 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.
- 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 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:
- GHS criteria not met
- 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.
Referenceopen allclose all
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
- Quality of whole database:
- The read-across study is reliable without restriction
Additional information
Justification for classification or non-classification
The source substance, boric acid, is not classified for acute oral toxicity as the LD50 values exceed the limits of classification; therefore, according to Regulation (EC) No. 1272/2008 no classification for acute oral toxicity is required for the target substance.
No mortality was observed in the acute dermal study for the source substance, boric acid, therefore in accordance with Regulation (EC) No. 1272/2008 no classification for acute dermal toxicity is required for the target substance.
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.