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Toxicological information

Acute Toxicity: inhalation

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Administrative data

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: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
The report lacks detail. Since the data is in line with other data on sodium borates, further testing is not warranted in the interests of animal welfare.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Disodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 4H02-2471
- Stability under test conditions: Stable

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PS.
- Age at study initiation: Young adults
- Weight at study initiation: Males 253- 278 g; females 218-245 g

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
MMAD: 3.1 µm + GSD .971 µm.
Top dose: ~ 2 mg/L was the highest that was obtainable under the conditions of the test.
Analytical concentration: 2040 + 160 mg/m³.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
2040 + 160 mg/m³
No. of animals per sex per dose:
Five/sex/dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Other examinations performed: Clinical signs, pathology.
Statistics:
No data - Limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.04 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: No lethal effect at limit dose.
Mortality:
None
Clinical signs:
Animal observations were limited due to the accumulation of test material on the walls of the exposure chamber. During the first hour of exposure, ocular discharge, hypoactivity and haunched posture were noted. Ocular discharge and a few animals exhibited nasal discharge and/or hunched position. All animals recovered by day six after removal from chamber.
Body weight:
No data
Gross pathology:
No specific findings.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not specified
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
Acute inhalation toxicity limit on disodium tetraborate pentahydrate gave a LC50 > 2.04 mg/L (2g/m3).