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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. Study conducted on the hydrolysis product of reference substance, boric acid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Boric acid
EC Number:
233-139-2
EC Name:
Boric acid
Cas Number:
10043-35-3
Molecular formula:
BH3O3
IUPAC Name:
Boric acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Boric acid, Manufacturing Grade > 99 %
- Substance type: Solid
- Physical state: White poweder
- Analytical purity: >99 %
- Lot/batch No.: 7B10
- Stability under test conditions: Stable
- Other: Sample was ground in a ball mill for 24 h

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
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 to confirm that the highest dose obtainable was 2 mg/L.
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

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.