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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
2 mg/m³ air

Acute toxicity: via dermal route

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, calcium salt is of low acute toxicity. Although some of the acute oral studies conducted with boric acid 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 with boric acid do meet the modern GLP standard.


Justification for classification or non-classification

EC 701 -311 -0 is not classified for the oral, dermal or inhalation routes, as the LD50 values from read-across studies exceed the limit for classification.