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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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed pre-GLP and no guideline is mentioned. Very limited data is provided on the methods and results, only a 2 page summary. No data on test substance composition or purity. Full evaluation of the validity of this study is not possible.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further information.

Test animals

Species:
rat
Strain:
other: Charles River CD strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 218 to 264 grams
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
No data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
100, 200, 400, 800 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made during exposure and daily afterwards, the bodyweight of the animals was determined pre-exposure and at the termination of the study.
- Necropsy of survivors performed: no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 800 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
1 females died at 800 mg/L
Clinical signs:
other: See table
Body weight:
A decrease in bodyweight gain was noted during the study.
Gross pathology:
The female rat which died at the 800 mg/L exposure level had moderately congested lungs and focal congestion of the glandular mucosa of the stomach.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute inhalation (LC50) value in male and female albino rats would be greater than 800 mg/L
Executive summary:

Twenty male and 20 female albino rats of the Charles River CD strain, weighing 218 to 264 grams, were divided equally into 4 dosage groups. Each group of rats was placed in a sealed 59.1 litre glass chamber and exposed to the appropriate level, 100, 200, 400 or 800 mg/L, of test material for 4 hours.

Observations for pharmacodynamic signs and mortality were made during the exposure and daily for 14 days. 1 female died at 800 mg/L. The acute inhalation (LC50) value in male and female albino rats would be greater than 800 mg/L