Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
pale yellow powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
aerodynamic dyameter of particle size = 6.0 microns +- 2.22.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric
Duration of exposure:
1 h
Concentrations:
203 mg/L
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
203 mg/L air
Based on:
test mat.
Exp. duration:
1 h

Any other information on results incl. tables

No rats died on the study.

Dyspnea was observed during the exposure and continued post-exposure (up to 5 days) in a few animals. Mean body weight gain was normal 14 days after exposure. At necropsy, red foci in the lungs of a few rats were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The 1 hr LC50 was > 203 mg/L.
Executive summary:

One group of 5 male and 5 female albino rats was exposed to EBTBP at a concentration of 203 mg/L for 1 hour. Dyspnea and nasal discharge were the principal signs observed during the exposure. No deaths occurred during treatment or the during the 14 day observation period. The inhalation LC50 was > 203 mg/L for 1 hour. This study was performed according to Good Laboratory Practices.