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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not indicated
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Non-GLP study performed according to a method similar to the Inhalation Hazard Test in the annex of OECD Guideline 403. Rats were exposed 8 h instead of 7 h. Details on the method are partly lacking and can thus not be compared with the guideline: documentation insufficient for assessment.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
8h exposure (instead of 7h); temperature 26°C (instead of 19-25°C); air flow 360 L/h (instead of 600L/h); further details on the method are lacking.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4236-14-25
Specific details on test material used for the study:
OTHER SPECIFICS:
- Name of test material (as cited in study report): 4236-14-25

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Chamber conditions:
size: 80 liters
atmospheric pressure: 29.49 inches Hg
temperature: 26 °C
air flow: 6.0 l/min

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
Generation of test material:
The vapor was generated by bubbling a stream of filtered, dry air (-40°C dewpoint) through the undiluted test material in a gas washing bottle. The resulting air-vapor mixture was then introduced into the exposure chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
nominal concentration: 0.21 mg/L air
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.21 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Mortality:
All animals survived
Clinical signs:
other: There were no untoward reactions during exposure or the 14-day observation period which followed.
Body weight:
The average 2-week body weight gain for all the test animals was within the normal limits.
weight change males: 74 grams
weigth change females: 28 grams
Gross pathology:
animal 10 (female): kidney: right hydronephrotic
animal 4 (male): lung: few minute red foci in all lobes
No gross tissue changes attributable to the effects of the test material were observed in any of the treated rats examined.

Applicant's summary and conclusion

Interpretation of results:
Category 1 based on GHS criteria
Conclusions:
The acute inhalation LC50 of the substance in rats was > 0.21 mg/L