Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981/08/27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This non-GLP study is similar to current guideline, but deviates significantly enough to warrant restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Minimal detail provided. No histopathology conducted to determine cause of gross pathology findings.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test article was stored in the original container at room temperature.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals weighing approximately 135 g were supplied by King Animal Labs. Upon arrival, the animals were quarantined to the laboratory for 1 week. Apparently healthy rats were selected for the study. Animals were housed 3/sex/cage and then individually after the exposure period in suspended stainless steel cages. Animal rooms were maintained at 22 °C, 40% humidity, and 12 h light cycles. Purina Rodent Chow 5001 and water were available ad libitum except during the exposure period.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
A generating system was used to generate concentrated vapor of the test article. An air-vapor mixture was produced by bubbling dry air at 5 L/min through 1 L of test article heated to 66 °C. This vapor mixture passed into the exposure chamber with no dilution air added.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
2.3 mg/L nominal concentration
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Rats were exposed for 4 h to vapours generated from a single batch of the test article. The projected exposure concentration was not to exceed 15 mg/l. The concentration of the test article in the atmosphere was determined by dividing the quantity for the test article consumed by the volume of air passed through the chamber during the exposure period (nominal concentration). All rats were observed for 14 days following exposure.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.3 mg/L air (nominal)
Exp. duration:
4 h
Mortality:
No animals died following exposure to the test article.

Clinical signs:
Diarrhea was noted in one rat following exposure. All remaining rats appeared normal.
Body weight:
All test rats were weighed immediately prior to exposure. Body weights were not recorded following the observation period for comparison.

Gross pathology:
Gross necropsy findings for nine rats were within normal limits. The remaining rat had red foci throughout the liver.
Other findings:
Tan livers and kidneys were observed at necropsy, however, these were not deemed to be treatment related.

Applicant's summary and conclusion

Interpretation of results:
other: Not classifiable
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the test material did not produce significant toxicity at the nominal concentration of 2.3 mg/l in male or female Sprague Dawley rats.
Executive summary:

In an acute inhalation toxicity study, male and female Wistar rats were exposed to test substance at a nominal concentration of 2.3 mg/l under continuous air flow conditions for 4 h. The LC50 is >2.3 mg/l. Diarrhea was noted in one animal, all other animals appeared normal. Based on the results of this study, the test substance would be unclassifiable in accordance with the classification system of GHS. The LC50 only eliminates Category 1 or 2 classification. This toxicity study is classified as acceptable and satisfies the guideline requirement for acute inhalation toxicity in rats.