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EC number: 234-521-1 | CAS number: 12007-89-5
- 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 the read-across substance 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:
- 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 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:
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 765 mg/kg bw
- Quality of whole database:
- High quality (there are a lot of reliable studies for different species available).
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
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- 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 245 - 296 g; females 232 - 251 g
- Housing: singly in suspended stainless steel cages with mesh floors which conform to the size recommendations in the Guide for the Care and use of Laboratory Animals DHEW (NIH) No. 86.23. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Water: Ad libitum by rack-top carboy except during exposure.
- Acclimation period: 22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69 - 71 ºF
- Photoperiod (hrs dark / hrs light): 12 h light/dark - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no data
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Rectangular whole body perspex chamber operated under slight negative pressure
- Exposure chamber volume: 100 L
TEST ATMOSPHERE
- Particle size distribution: An eight-stage Andersen cascade impactor was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals on 2 occassions. The filter paper collection stages were weighed before and after sampling to determine the mass collected at each stage. The aerodynamic mass median diamaeter and geometric standard deviation were determined graphically using two-cycle logarithmic probit axes. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Remarks on duration:
- The exposure period was extended to 4 h and 9 min to provide for the chamber to reach equilibrium (T99). The times for 90 and 99 % equilibrium of the chamber atmosphere were 4.6 and 9.1 min respectively.
- Concentrations:
- Top dose ~ 2 mg/L, to prevent undue discomfort to the animals.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for signs of gross toxicity, behavioural changes and mortality to exposure and every 15 min during the first 30 min of exposure. Additional in chamber animal observations were limited due to the accumulation of the test substance on the walls of the exposure chamber. Upon chamber removal, the animals were examined at least once daily for 14 days. Observations included gross evaluation of of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observations of tremors, convulsions, salivation, diarrhoea, sleep and coma.
- Necropsy of survivors performed: yes on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: Clinical signs, body weight, organ weights and histopathology. - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.03 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 5 h
- Mortality:
- No deaths occured.
- Clinical signs:
- other: Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During the first 30 minutes of exposure, ocular discharge, hypoactivity and haunched posture were noted. Ocular discharge and or nasal discharg
- Other findings:
- The gravimetric and nominal chamber concentrations were 2.03 and 110.40 mg/L respectively. The mass median aerodynamic diameter was estimated to be 3.7 microns based on graphic analysis of the particle size distribution as measured with an Andersen Cascade Impactor.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LC50 > 2.03 mg/L
No deaths occurred. Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During the first 30 minutes of exposure, ocular discharge, hypoactivity and haunched posture were noted. Ocular discharge and or nasal discharge persisted in most animals after removal from the chamber. All animals recovered by day seven.
Reference
Pre-test trial
Trial No. |
Compressed Air Pressure (psi) |
Compressed Air Volume (Lpm) |
Room Air Volume (Lpm) |
Total Air Volume (Lpm) |
Motor Setting |
Chamber Conc. (mg/L) |
Particle Size Sampled |
11 |
27 |
30 |
20.4 |
50.4 |
6.00 |
1.94 |
Yes |
22 |
27 |
30 |
20.6 |
50.6 |
6.00 |
1.64 |
No |
32 |
27 |
30 |
20.5 |
50.5 |
6.25 |
2.00 |
Yes |
43 |
27 |
30 |
20.4 |
50.4 |
6.00 |
2.40 |
No |
53 |
27 |
30 |
20.3 |
50.3 |
5.75 |
1.98 |
Yes |
64 |
27 |
30 |
20.2 |
50.2 |
4.50 |
5 |
- |
74 |
27 |
30 |
20.1 |
50.1 |
4.00 |
5 |
- |
84 |
27 |
30 |
20.2 |
50.2 |
4.00 |
5 |
- |
1Test substance used as received, unground
2Test substance used after grinding for 1 h in a ball mill
3Test substance used after grinding for 3 h in a ball mill
4Test substance used after grinding for 24 h in a ball mill
5Trial terminated due to the malfunction of the dust generator caused by the test substance
Summary of pre-test exposure trials1
Trial No. |
Chamber Concentration (mg/L) |
Mass Median Aerodynamic Diameter (microns)2 |
13 |
1.94 |
5.8 |
34 |
2.00 |
5.0 |
55 |
1.98 |
3.7 |
1 See table above for details of generation sysem
2 Figure is an estimation based on graphic analysis of the particle size distribution as measured with an Andersen Cascade Impactor
3 Test substance used as received, unground
4 Test substance used after grinding for 1 h in a ball mill
5 test substance used after grinding for 3 h in a ball mill
Gravimetric chamber concentrations
Sample No. |
Mass Collected (mg) |
Airflow Sampled (Lpm) |
Collection Time (min) |
Chamber concentration (mg/L) |
1 |
11.9 |
4 |
2 |
1.49 |
2 |
12.1 |
4 |
2 |
1.52 |
3 |
11.8 |
4 |
2 |
1.48 |
4 |
8.6 |
4 |
2 |
10.8 |
51 |
24.8 |
4 |
2 |
3.10 |
6 |
17.7 |
4 |
2 |
2.21 |
7 |
12.8 |
4 |
2 |
1.60 |
8 |
17.5 |
4 |
2 |
2.19 |
9 |
19.4 |
4 |
2 |
2.40 |
10 |
20.4 |
4 |
2 |
2.55 |
11 |
20.3 |
4 |
2 |
2.54 |
12 |
16.5 |
4 |
2 |
2.06 |
13 |
16.1 |
4 |
2 |
2.01 |
14 |
17.2 |
4 |
2 |
2.15 |
Average ± Standard Deviation |
2.03 ± 0.54 |
1 due to the extremely low chamber concentrations recorded during samples 1 - 4, diluent air being supplied to the chamber was reduced from 30 to 15 Lpm prior ot sample #5.
Particle size distribution
Stage |
Effective cutoff diameter (microns) |
% of total particles captured (by weight) |
Cumulative (%)1 |
Sample 1 |
|||
0 |
9.0 |
5.3 |
94.7 |
1 |
5.8 |
12.9 |
81.8 |
2 |
4.7 |
10.1 |
71.7 |
3 |
3.3 |
31.1 |
40.7 |
4 |
2.1 |
22.7 |
17.9 |
5 |
1.1 |
13.6 |
4.3 |
6 |
0.7 |
3.3 |
1.0 |
7 |
0.4 |
0.8 |
0.3 |
F |
0.0 |
0.3 |
0.0 |
Sample 2 |
|||
0 |
9.0 |
9.3 |
90.7 |
1 |
5.8 |
15.9 |
74.8 |
2 |
4.7 |
11.0 |
63.8 |
3 |
3.3 |
24.4 |
39.4 |
4 |
2.1 |
22.2 |
17.2 |
5 |
1.1 |
13.8 |
3.4 |
6 |
0.7 |
2.2 |
1.1 |
7 |
0.4 |
0.7 |
0.4 |
F |
0.0 |
0.4 |
0.0 |
1 percent of particles smaller than corresponding effective cutoff
Summary of particle size distribution
Sample No |
Sampling time (min) |
MMAD (microns)1 |
Geometric Standard Deviation |
1 |
4 |
3.6 |
1.82 |
2 |
4 |
6.7 |
1.87 |
1This figure is an estimation based on graphic analysis of the particle size distribution as measured with an Andersen Cascade Impactor
Individual bodyweights
Animal No. |
Sex |
Bodyweight (g) |
||
Initial |
Day7 |
Day 14 |
||
5399 |
M |
296 |
361 |
398 |
5400 |
M |
257 |
310 |
343 |
5401 |
M |
245 |
307 |
349 |
5402 |
M |
260 |
316 |
340 |
5403 |
M |
262 |
298 |
322 |
5404 |
F |
232 |
250 |
261 |
5405 |
F |
237 |
258 |
273 |
5406 |
F |
236 |
263 |
289 |
5407 |
F |
251 |
275 |
260 |
5408 |
F |
234 |
267 |
275 |
Individual cage-side observations
Animal no. |
Finding |
Day of occurrence |
Males |
||
5399 |
Ocular discharge |
CR1 |
Test substance on fur |
CR-0 (20.5 h) |
|
Nasal discharge |
CR-6 |
|
Active and healthy |
7-14 |
|
5400 |
Nasal discharge, test substance on fur |
CR-0 (20.5 h) |
Active and healthy |
2 – 14 |
|
5401 |
Test substance on fur |
CR |
Nasal discharge |
CR-0 (20.5 h) |
|
Active and healthy |
2-14 |
|
5402 |
Ocular discharge, test substance on fur |
CR |
Nasal discharge |
CR-0 (20.5 h), 4 - 6 |
|
Piloerection |
2 – 3 |
|
Active and healthy |
7 - 14 |
|
5403 |
Ocular discharge, test substance on fur |
CR |
Nasal discharge |
CR-0 (20.5 h) |
|
Active and healthy |
2 – 3, 6 – 14 |
|
Ano-genital staining |
4 - 5 |
|
Females |
||
5404 |
Nasal discharge, test substance on fur |
CR1-0 (20.5 h) |
Active and healthy |
2 - 14 |
|
5405 |
Test substance on fur |
CR-0 (20.5 h) |
Nasal discharge |
CR-5 |
|
Active and healthy |
6 - 14 |
|
5406 |
Ocular discharge, nasal discharge, test substance on fur |
CR |
Active and healthy |
0 (20.5 h)-14 |
|
5407 |
Ocular discharge, test substance on fur |
CR |
Nasal discharge |
CR-0 (20.5) |
|
Active and healthy |
2 – 14 |
|
5408
|
Test substance on fur |
CR |
Active and healthy |
0 (20.5 h)-14 |
Individual necropsy observations
Animal No. |
Tissue |
Findings |
Males |
||
53999 - 5403 |
Lungs |
Moderately red1 |
Females |
||
5404 - 5408 |
Lungs |
Moderately red1 |
1customarily seen with CO2 inhlation euthanasia procedure
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 000 mg/m³ air
- Quality of whole database:
- High quality (3 reliable studies 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:
- 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:
- 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.
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
- Quality of whole database:
- 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. 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
The study meets generally accepted scientific standards with
acceptable restrictions.
Justification for selection of acute toxicity – inhalation endpoint
The study is GLP compliant and has Klimisch score of 1.
Justification for selection of acute toxicity – dermal endpoint
Best study available.
Read Across
A number of these studies were conducted on an analogue substance. Read-across is justified on the following basis: In aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid B(OH)3, diammonium decaborate (B5H4NO8), disodium tetraborate decahydrate (Na2B4O7.10H2O; borax), disodium tetraborate pentahydrate (Na2B4O7.5H2O; borax pentahydrate), boric oxide (B2O3) and disodium octaborate tetrahydrate (Na2B8O13.4H2O) will predominantly exist as undissociated boric acid. Above pH 9 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is undissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as undissociated boric acid under the same conditions.For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance.Conversion factors are given in the table under CSR section 5.1.3, which corresponds to IUCLID section 7.1 (toxicokinetics, metabolism and distribution endpoint summary).References:WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998
Justification for classification or non-classification
No classification is required regarding the oral, dermal or inhalation routes as as the LD50 values 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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