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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:
disregarded due to major methodological deficiencies
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

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:
EPA OPP 81-3 (Acute inhalation toxicity)
Version / remarks:
Acute Inhalation Study. FHSLA, CFR, Title 21, para. 191.10
Deviations:
yes
Principles of method if other than guideline:
the main deviation is the exposure duration of 1 h. In addition no information on body weight gain is provided.
GLP compliance:
no
Test type:
traditional method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
43% in water/(iso)propanol

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Weight at study initiation: Males 255-280 g; females 237-261 9
- Fasting period before study: NA
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Remark on MMAD/GSD:
no data
Details on inhalation exposure:
exposure to vaporized substance
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Remarks on duration:
deviation from the guideline
Concentrations:
22 mg/L
No. of animals per sex per dose:
5 males and 5 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 22 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 9.5 mg/L air
Based on:
act. ingr.
Exp. duration:
1 h
Remarks on result:
other: corrected for purity based on a density of 1 mg/cm3
Mortality:
1 male died on day 6
Clinical signs:
none reported
Body weight:
no data on body weight gain
Gross pathology:
pulmonary congestion in animal that died

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No definite conclusion can be drawn.
Executive summary:

Five rats/sex were exposed to the substance during 1 hour at 22 mg/L(nominal). One animal died, showing pulmonary congestion. No toxic effects were seen in the other animals. The LC50 is > 9.5 mg/L (corrected for purity).