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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

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, 3 males and 3 females per experiment, 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. Since the substance is UV light sensitive, the experiment was performed in the dark. 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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Initiator 654
- Physical state: yellow liquid
- Analytical purity: > 97%
- Expiration date of the lot/batch: Feb. 1983

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Three animals per cage; type: wire cage (Becker, D III)
Identification of animals: Toe amputation
Age at start of study: 8 - 9 weeks
Acclimatization period: At least 5 days
Weight of animals at start of study: males 293 g, females 233 g (on average)
Animal housing / room temperature: 22 ± 2°C
Relative humidity: 55 ± 5%
Illumination day/night rhythm: 12 h/12 h (6.00 - 18.00 hours light, 18.00 - 6.00 hours dark)
The animals received SSNIFF R complete diet for rats and mice, supplied by SSNIFF Versuchstierdiäten GmbH, Soest, FRG, in the form of pellets ad libitum and about 250 ml/cage tap water daily.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Remarks on duration:
14 day observation period
Concentrations:
no substance loss could be determined over the course of the experiment. Based on the saturated vapour pressure, the saturated vapour concentration can be calculated to be 2.7e-5 mg/l.
No. of animals per sex per dose:
6 (3 per sex each in 2 independent experiments)
Control animals:
no
Details on study design:
Clinical signs and mortality of the animals were recorded each workday and daily, respectively. The animals that died or those sacrificed with carbon dioxide at the end of the post-exposure observation period were subjected to a gross-pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 0 mg/L air
Based on:
other: calculated (equals saturated vapour concentration)
Exp. duration:
7 h
Mortality:
None
Clinical signs:
other: No abnormalities detected.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification