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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:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Only limited information on procedure and results is given in the study report. Substantially saturated vapour was generated in a gas washing bottle by passing dired air at 2.5 L/min through a fritted glas dish immersed to a depth of at least 1.5 inches in the chemical. This air was delivered to rats in a 9 L glass exposure chamber.
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): Silane 44-42 (organofunctional), Dynasylan 1189
- Physical state: yellow liquid
- Lot/batch No.: 09989

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: none
- Diet: appropriate diet ad libitum (not further specified)
- Water: ad libitum (not further specified)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 9 L-glass exposure chamber
- Exposure chamber volume: 9 L
- Rate of air: 2.5 L/min
- System of generating substantially saturated vapour: dynamic exposure, vapour was generated in a gas washing bottle by passing dired air through a fritted glass dish, immersed to a depth of at least 1.5 inches in the chemical
- Temperature in air chamber: 25 °C

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Mean vapour concentration was calculated from the loss in weight of the liquid or extimated from the vapour pressure at the actual temperature of the chemical during aeration.
Duration of exposure:
6 h
Concentrations:
substantially saturated vapour, not further specified
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The LC50 along with the 95% confidence limits was calculated by the moving average method based on a 14 day observation period.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
other: Substantially saturated vapour
Based on:
test mat.
Exp. duration:
6 h
Mortality:
No mortality occured during the study period.
Clinical signs:
other:
Body weight:
Mean body weight change seen throughout the study period was 84 g (81-90 g). No further details are given in the study report.
Gross pathology:
Gross pathology revealed no remarkable findings.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In a non-guideline study, which was not compliant to GLP, the test item was tested for acute inhalation toxicity. Substantially saturated vapour did not cause any deaths or signs of toxicity in any of the male rats after 6 h of exposure. The LC50 was found to be > vapour saturation at 25°C.