Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: sufficiently documented study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20°C. Young adult laboratory rats, 6 per sex, were exposed 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 7 h. Every 30minutes, the glass cylinder was exchanged against one containing fresh substance. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 14 day study period.
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2.4.6-trimehtylbenzoylchlorid
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Average Weight at study initiation: males: 218g, females: 182

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: closed glass tubes
- Rate of air: 200l/h
- Temperature, pressure in air chamber:20°C, 737mbar

TEST ATMOSPHERE
- Brief description of analytical method used: no analytics performed
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
on average 0.357mg/l or 478ppm
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 0.357 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Mortality:
no mortality occured
Clinical signs:
other: during exposure: wiping of eyes and nose, slightly clotted eyes
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
A saturated atmosphere of the test substance, corresponding to 0.357mg/l, did not lead to mortality in rats after a 7h exposure.