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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study conducted during the period June 1971 to May 1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Silane
EC Number:
232-263-4
EC Name:
Silane
Cas Number:
7803-62-5
Molecular formula:
H4Si
IUPAC Name:
silane

Test animals

Species:
other: rat and mouse
Strain:
other: CFE and CF1, respectively.
Sex:
male
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: nitrogen
Details on inhalation exposure:
No data.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Beckman Infrared 5-A spectrophotometer
Duration of exposure:
1 - 4 h
Concentrations:
1000, 4000, 6000, 10000 ppm
No. of animals per sex per dose:
5-50 males
Control animals:
yes
Details on study design:
No data.
Statistics:
No data.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 9 600 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: based on 4/10 deaths at this concentration in mice
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 9 600 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: based on 0/5 deaths in rats (equivalent to >12611 mg/m³)
Mortality:
See Table 1.
Clinical signs:
other: No data.
Body weight:
No data.
Gross pathology:
No data.
Other findings:
No data.

Any other information on results incl. tables

Table 1 Summary of results for acute inhalation studies in rats and mice

 Species  Nominal concentration (ppm) Measured concentration (ppm)   Measured concentration (mg/l)  Exp. time (h)  Mortality  Time to death
 Rat  1000  -  -  1.25  0/50  -
 Rat  4000  -  -  1  0/5  -
 Rat  10000  9600  12.6  4  0/5  -
 Mouse  6000  -  -  1  0/5  -
 Mouse  10000  9600  12.6  4  4/10  31 -45 h
 Mouse  10000  9800  12.8  2  0/10  -

The mean weight gain of the 9600 ppm group appears to have been slightly inhibited during the first post-exposure week, but fully recovered at 14 days. No gross lesions due to treatment were observed at sacrifice. A gross pathological examination of the animals that died was not conducted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation study conducted using a protocol similar to OECD Test Guideline 403 prior to the introduction of GLP (reliability score 2), a concentration of 9600 ppm silane for 4 hours caused deaths in 4 of 10 mice. A concentration of 9600 ppm for 4 hours did not cause any deaths in five rats. Hence the LC50s for mice and rats were approximately 10000 ppm and >9600 ppm, respectively.