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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
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- Oxidation reduction potential
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- 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
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- 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.
In a read-across 2-year dietary study in Sprague Dawley rats (35/sex/treated group and 70 controls/sex) with interim kills of 5/sex/group at 6 and 12 months, rats were fed 0, 33 (5.9), 100 (17.5), 334 (58.5) mg boric acid (B)/kg bw/day. No adverse effects were observed in the low and mid-dose group. In the top dose group clinical signs, such as coarse hair coats, hunched position, swollen pads and inflamed bleeding eyes were reported. Survival at 6, 12 and 24 months was comparable in all groups including controls. Reduced body weight gain and reduced food intake were identified in the top dose group and significantly decreased red cell volume and haemoglobin were reported in top-dose males at 3, 6, 12, 18 and 24 months. Testes weights and the testes/bodyweight ratios were significantly lower compared to the controls and microscopic examination of the tissue revealed atrophied seminiferous epithelium and decreased tubular size in the testes. Based on these effects a NOAEL of 100 mg/kg bw/day (17.5 mg B/kg bw/day (nominal)) was identified for the source substance, boric acid.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic 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
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 334 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on testicular atrophy in males and reduced body weight in females
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: Based on testicular atrophy in males and reduced body weight in females.
- Critical effects observed:
- not specified
- Conclusions:
- Endpoint Effect level
NOAEL 100 mg/kg bw/day (17.5 mg boron/kg bw/day (nominal))
LOAEL 334 mg/kg bw/day (58.5 mg boron/kg bw/day (nominal))
Testicular atrophy and seminiferous tubule degeneration was observed at 6, 12 and 24 months at the highest dose level only. No treatment related effects were observed in the mid and low dose groups. - Endpoint:
- chronic 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not specified
- Principles of method if other than guideline:
- 2 year dietary feeding study in Sprague Dawley rats, 35 per sex per treated group and 70 controls per sex with interim kills of 5/sex/group at 6 and 12 months at 0; 670 (117); 2000 (350); 6690 (1170) ppm boric acid (ppm as boron equivalents) equivalent to 0, 33 (5.9), 100 (17.5), 334 (58.5) mg boric acid (B)/kg bw per day.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- 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 93 - 129 g; females 86 - 128 g - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily; ad libitum.
- Remarks:
- Doses / Concentrations:
0; 670 (117); 2000 (350); 6690 (1170) ppm boric acid (ppm as boron equivalents) equivalent to 0, 33 (5.9), 100 (17.5), 334 (58.5) mg boric acid (B)/kg bw per day
Basis:
nominal in diet - No. of animals per sex per dose:
- 35/sex/group
- Control animals:
- yes, plain diet
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: recorded weekly for the first 52 weeks, then 4 weekly
BODY WEIGHT: Yes
- Time schedule for examinations: recorded weekly for the first 52 weeks, then 4 weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): recorded weekly for the first 52 weeks, then 4 weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood:at 1, 2, 3, 6 ,12, 18 and end of study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: on 5/sex/group
- Parameters examined: Haematocrit, haemoglobin concentration, erythrocyte count, total and differential leukocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at interim sacrifice at 6, 18 and 24 months for blood pH, sodium, potassium, chloride and carbon dioxide combining power; and at 6, 12 and 24 months for SGOT and SGPT
- Animals fasted: No data
- How many animals: 2/sex/group except SGOT and SGPT which were in 5/sex/group in the hihg and control dose groups
- Parameters: blood pH, sodium, potassium, chloride, carbon dioxide combining power, SGOT and SGPT
URINALYSIS: Yes
- Time schedule for collection of urine: at 6 months
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: appearance, volume, osmolality, specific gravity, pH, protein, glucose, blood, acetone, bilirubin and microscopy - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes at 6 and 12 months 5 rats per sex per group, all interim deaths and at termination in 10 per sex per group in controls and high dose surviving animals.
Organs: Brain, pituitary, thyroid, stomach, small and large intestines, liver, pancreas, kidneys, adrenals, spleen, heart, lungs, gonads, urinary bladder, sternum, rib junction and all unusual lesions.
HISTOPATHOLOGY: Yes 10 rats per sex per group from the mid and low dose groups had gonads examined histologically - Other examinations:
- Samples of blood, brain, liver and kidney were taken at 6, 12 and 24 months and frozen for boron analysis.
- Statistics:
- As appropriate.
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No signs in the low and mid dose groups. Coarse hair coats, hunched position, swollen pads and inflamed bleeding eyes were observed in animals receiving the highest dose of boric acid.
Survival at 6, 12 and 24 months was comparable in all groups including controls.
BODY WEIGHT AND WEIGHT GAIN
No difference from controls in the low and mid dose group. Retarded body weight gain in animals receiving the highest dose of boric acid.
FOOD CONSUMPTION AND COMPOUND INTAKE
No difference from controls in the low and mid dose group. Reduced food intake in the highest dose group during weeks 1-13 in males, and in weeks 1-13 and 42-52 in females.
HAEMATOLOGY
No difference from controls in the low and mid dose groups. Significantly decreased red cell volume and haemoglobin were observed in the high dose group males at 3, 6, 12, 18 and 24 months. Hemoglobin values for the males in the high level test group were consistently below the normal range for adult male rats. Cell volume values for this group were, at most periods of determination, also below normal or within low normal range. The total leukocyte counts for the high level males were lower than those for the male controls at each determination but generally within normal limits. The hematological values determined during the first year for the low and intermediate level males and the females at all three test levels were generally within normal limits and comparable with the control values.
CLINICAL CHEMISTRY
No significant differences between groups.
URINALYSIS
No significant differences between groups.
ORGAN WEIGHTS
The testes weights and the testes/bodyweight ratios were significantly lower in the high dose group than those of control animals. The brain- and thyroid-to-bodyweight ratios in the high dose females were significantly higher than those of controls. This was thought to relate to the reduced bodyweight of the animals.
GROSS PATHOLOGYAND HISTOPATHOLOGY
Atrophic testes were found in all males exposed to the high dose 334 (58.5) mg boric acid (B)/kg bw) of boric acid at 6, 12 and 24 months. Microscopic examination of the tissue revealed atrophied seminiferous epithelium and decreased tubular size in the testes. Cysts in the eyelids, probably in the Meiobomian glands were observed in 4 high dose females, probably related to treatment. There was no treatment related increase in tissue masses. - Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 334 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on testicular atrophy in males and reduced body weight in females
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: Based on testicular atrophy in males and reduced body weight in females.
- Critical effects observed:
- not specified
- Conclusions:
- Endpoint Effect level
NOAEL 17.5 mg Boron/kg bw/day (nominal)
LOAEL 58.5 mg Boron/kg bw/day (nominal)
Testicular atrophy and seminiferous tubule degeneration was observed at 6, 12 and 24 months at the highest dose level only. No treatment related effects were observed in the mid and low dose groups.
Referenceopen allclose all
Parameter |
Control |
Low dose |
Medium dose |
High dose |
Dose- response +/- |
|||||
ma |
fa |
ma |
fa |
ma |
fa |
ma |
fa |
m |
f |
|
number of animals examined |
70 |
70 |
35 |
35 |
35 |
35 |
35 |
35 |
|
|
Mortality at 104 weeks |
25/60 |
20/60 |
6/25 |
8/25 |
9/25 |
10/24 |
7/25 |
5/25 |
N |
N |
clinical signs* |
|
|
|
|
|
|
|
|
|
|
body weight gain 0-104 weeks (g) |
557 |
405 |
546 |
318 |
499 |
359 |
449 |
238 |
Y |
Y |
food consumption at week 52 (g/kg/day) |
33.3 |
43.7 |
35.4 |
42.9 |
35.3 |
44.6 |
39.7 |
52.7 |
|
|
clinical chemistry* |
no differences |
|
|
|
|
|
|
|
|
|
haematology* |
see separate table |
|
|
|
|
|
|
|
|
|
urinalysis* |
No differences |
|
|
|
|
|
|
|
|
|
testes weight*(g) at 26 weeks |
3.76+0.29 |
|
3.67+0.29 |
|
3.81+0.14 |
|
0.95+0.06 sig low |
|
|
|
testes weight (g) at 104 weeks |
3.65+0.84 |
|
3.65+0.63 |
|
3.30+0.60 |
|
0.99+0.24 sig low |
|
|
|
microscopic pathology* Testes atrophy at 24 months |
3/10 |
|
1/10 |
|
4/10 |
|
10/10 |
|
|
|
Summary of haematological data from 2 year rat study boric acid:
Months |
Cell Volume (%) |
|||
Male |
||||
Control |
0.067% |
0.2% |
0.67% |
|
0 |
5.9 mg B/kg |
17.5 mg B/kg |
58.5 mg B/kg |
|
1 |
42.6 |
45.3 |
42.7 |
39.0 |
2 |
44.1 |
44.9 |
45.5 |
40.8* |
3 |
45.9 |
46.7 |
45.7 |
39.7* |
6 |
45.4 |
45.9 |
46.5 |
44.6 |
12 |
47.3 |
45.5 |
44.8 |
41.4* |
18 |
47.8 |
43.2* |
42.8* |
39.2* |
24 |
46.4 |
36.4* |
43.8 |
41.68 |
|
Female |
|||
1 |
42.1 |
44.5 |
42.4 |
43.3 |
2 |
41.7 |
43.7 |
43.0 |
40.8 |
3 |
44.2 |
47.2 |
45.1 |
42.0 |
6 |
43.3 |
44.7 |
Data missing |
|
12 |
42.8 |
43.9 |
41.8 |
40.6 |
18 |
43.0 |
43.0 |
42.8 |
39.3* |
24 |
46.2 |
45.6 |
44.4 |
41.6 |
Months |
Hb Value (g/100 mL) |
|||
Male |
||||
Control |
0.067% |
0.2% |
0.67% |
|
0 |
5.9 mg B/kg |
17.5 mg B/kg |
58.5 mg B/kg |
|
1 |
14.5 |
14.2 |
14.2 |
12.6* |
2 |
14.7 |
14.1 |
14.4 |
13.2 |
3 |
15.7 |
15.2 |
14.9 |
13.3* |
6 |
15.4 |
15.0 |
14.2 |
13.7* |
12 |
14.1 |
13.2 |
13.4 |
12.6* |
18 |
15.6 |
14.9 |
13.8* |
12.7* |
24 |
14.7 |
11.9 |
13.6* |
12.8* |
|
Female |
|||
1 |
14.6 |
15.3 |
14.3 |
14.0 |
2 |
14.9 |
15.2 |
14.4 |
14.7 |
3 |
14.9 |
15.7 |
14.0 |
14.2 |
6 |
14.5 |
14.8 |
Data missing |
|
12 |
12.9 |
13.2 |
13.2 |
12.6 |
18 |
14.8 |
13.9 |
14.6 |
13.6 |
24 |
14.4 |
13.2* |
13.0* |
12.5* |
Months |
WBC Count (x103/cm2) |
|||
Male |
||||
Control |
0.067% |
0.2% |
0.67% |
|
0 |
5.9 mg B/kg |
17.5 mg B/kg |
58.5 mg B/kg |
|
1 |
18.1 |
13.6 |
15.3 |
8.0* |
2 |
19.3 |
18.4 |
16.8 |
14.7 |
3 |
20.9 |
23.4 |
19.4 |
16.7 |
6 |
19.4 |
15.6 |
14.3 |
15.3 |
12 |
10.9 |
10.9 |
10.9 |
10.5 |
18 |
23.4 |
22.9 |
19.5 |
18.4 |
24 |
19.8 |
18.1 |
14.3 |
13.2* |
|
Female |
|||
1 |
19.8 |
20.9 |
17.3 |
14.7 |
2 |
16.6 |
28.9 |
17.1 |
17.4 |
3 |
26.6 |
19.0 |
18.6 |
21.1 |
6 |
14.6 |
14.1 |
Data missing |
|
12 |
9.5 |
13.5 |
7.3 |
11.4 |
18 |
10.9 |
11.5 |
16.4 |
11.6 |
24 |
17.6 |
12.8 |
11.3 |
10.5 |
Months |
RBC Count (x103/cm2) |
|||
Male |
||||
Control |
0.067% |
0.2% |
0.67% |
|
0 |
5.9 mg B/kg |
17.5 mg B/kg |
58.5 mg B/kg |
|
1 |
|
|
|
|
2 |
8.2 |
7.68 |
7.98 |
7.00* |
3 |
7.14 |
6.72 |
7.47 |
6.47 |
6 |
|
|
|
|
12 |
|
|
|
|
18 |
5.16 |
5.46 |
5.55 |
4.92 |
24 |
7.09 |
5.72 |
7.35 |
7.90 |
|
Female |
|||
1 |
|
|
|
|
2 |
7.36 |
7.44 |
7.46 |
7.57 |
3 |
5.64 |
7.03 |
6.47 |
6.52 |
6 |
|
|
|
|
12 |
|
|
|
|
18 |
6.58 |
6.11 |
5.69 |
5.73 |
24 |
6.22 |
6.24 |
6.22 |
5.92 |
* Significantly different from controls
Missing data not thought to be significant according to the summary of the study
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The read-across study is reliable with restrictions
- System:
- male reproductive system
- Organ:
- seminiferous tubules
- testes
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In accordance to Regulation (EC) No 1272/2008, the source substance, boric acid, is classified as Repr. 1B H360FD and is considered a suitable analogue; therefore, it is concluded the target substance is also classified as Repr. 1B H360FD and does not warrant an additional classification for STOT-RE.
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.