Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971-06-28 to 1971-08-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: equivalent to guideline study; no GLP study, but acceptable, well-documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
the study was performed prior to the adoption of the OECD Guideline
Deviations:
yes
Remarks:
see below "Principles of method if other than guideline"
Principles of method if other than guideline:
One concentration level for a one-hour period was tested.
GLP compliance:
no
Test type:
other: Acute Inhalation Toxicity
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CR-39, 62310-31-151- 1006
- Substance type: organic
- Physical state: clear colorless liquid
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Composition of test material, percentage of components (from a conversation letter of PPG Industries Inc. and the test facility, dated 1971-06-08):
- total chlorine 0.02 %,
- chloroformate chlorine <0.001% ,
- volatile material 0.21%
- Isomers composition: data not available
- Purity test date: data not available
- Lot/batch No.: 62310-31-151- 1006
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
The average nominal vapor concentration, calculated by dividing the generator weight loss by the total volume of air used during the test, was 0. 73 mg/L air at 29. 92 inches Hg and 25 °C
No. of animals per sex per dose:
5 males/5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: average nominal vapor concentration
Effect level:
0.73 mg/L air (nominal)
Exp. duration:
1 h
Remarks on result:
other: No deaths and no treatment realted effects

Any other information on results incl. tables

No deaths or untoward behavioral reactions were noted during the exposure period. The 14-day observation period was uneventful.

The average 14-day body weight gain was 48 grams which is within normal limits.

Necropsy did not reveal any gross pathologic alterations which could be attributed to inhalation of test material vapors.

Applicant's summary and conclusion

Interpretation of results:
other: Single exposure level tested might be unsufficient to interpret the results
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
No toxic effects of test material could be determined in test animals after the single level acute inhalation.
Executive summary:

An acute inhalation toxicity study was conducted (prior to the adoption of the OECD Guideline) wherein a group of ten albino rats was exposed to the vapors of CR-39 for a one-hour period at an average nominal concentration of 0.73 mg/L air. After exposure, the test animals were observed for the following 14 days.

No deaths, untoward behavioral reactions or gross pathologic alterations were noted in any of the test animals. Body weight gains were within the normal limits.