Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was performed prior to the implementation of GLP and OECD Guidelines, but meets the principles of an acute inhalation toxicity study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
8h inhalation exposure to a saturated test item atmosphere
according to Smyth et al.: Am. Ind. Hyg. Ass. J., 23, 95-107 (1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Diisopropanol-p-toluidin

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
mean body weight at study start: 203 g

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
Two groups of 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 hours.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
saturated atmophere at 20°C
No. of animals per sex per dose:
3 rats (total of 12 rats tested in two subsequent experiments)
Control animals:
no
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- observation period: 7 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
other: saturated atmosphere
Based on:
test mat.
Exp. duration:
8 h
Mortality:
none
Clinical signs:
no abnormality detected
Gross pathology:
no abnormality detected

Applicant's summary and conclusion