Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
other: Acute Aspiration Toxicity
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: other TS: origin: Esso Research and Engineering Company

Test animals

Species:
rat
Sex:
male
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Weight at study initiation: 185; 190; 196; 205; 206 g
- Controls: negative: tap water; positive: kerosene

Administration / exposure

Route of administration:
other: Aspiration
Details on exposure:
ADMINISTRATION: see Method 
- Total volume applied: 0.2 ml (undiluted)
- Removal of test substance: no
No. of animals per sex per dose:
5
Details on study design:
Rats were anesthetized with diethyl ether vapor to the point of apnea and  0.2 ml of the test substance was placed in the mouth of each animal.  Animals were held in a vertical position, and nostrils were closed to  promote entry of liquid into the trachea. Then animals were returned to  their cages for a 24 hour observation period, after which all surviving  animals were sacrificed, and lungs were removed from all of the dosed  animals.

EXAMINATIONS: 
mortality; weight of lung

Results and discussion

Mortality:
- Time of death: within minutes after dosing
- Number of deaths at each dose: 3 out of 5
Gross pathology:
The weight of the lungs was < 1.5 g for both of the two surviving animals  and > 2.5 g for each of the three dead animals.

Applicant's summary and conclusion

Conclusions:
Deaths were due to cardiac failure or respiratory arrest or both, rather than pulmonary edema. Isophorone presents potential aspiration hazard.