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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:
other information
Study period:
13. Aug 1968 - 02. Sep 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no
Test type:
other: Inhalation Risk Test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 173 g (mean)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
11. 24 mg/L (calculated from substance loss)
(calculated saturated vapor concentration: 6.6 mg/l)
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of administration, at least once each workday.
- Frequency of weighing: days 0, 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 11.24 mg/L air (nominal)
Exp. duration:
8 h
Remarks on result:
other: Inhalation Risk Test: Substance concentration was calculated from substance loss during the exposure
Mortality:
No mortality occured.
Clinical signs:
other: During the exposure escape attempts, irritation of the mucous membranes and intense respiration. At the end of the exposure period high stepping almost staggering gait, tremor of the whole body. 24 h post application piloerection and calm behaviour. 48 h
Body weight:
The animals gained weight (no single recording of weight gain).
Gross pathology:
1x bronchial pneumonia (right) and vicariious emphysema (left); 1x chronic bronchitis and bronchiectasis.

Any other information on results incl. tables

The inhalation of a highly saturated vapor-air-mixture at 20 °C caused no mortality after 8 h of exposure.

Applicant's summary and conclusion