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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:
key study
Study period:
17 June to 7 July 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
1 hour exposure period
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichlorosilane
EC Number:
223-888-3
EC Name:
Dichlorosilane
Cas Number:
4109-96-0
Molecular formula:
Cl2H2Si
IUPAC Name:
dichlorosilane
Test material form:
other: gas

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Inc., USA
- Age at study initiation: 63 to 77 days
- Weight at study initiation: 234-298 g (male), 200-243 g (female)
- Fasting period before study: no
- Housing: stainless steel wire mesh cages
- Diet (ad libitum): pelleted feed (Purina Co., USA)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 42 - 69
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 May 1986 To: 7 July 1986

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: cuboidal stainless-steel and Plexiglass chamber
- Exposure chamber volume: 120 L
- Method of holding animals in test chamber: wire mesh cage
- Source and rate of air: 30 or 50 L/min
- Method of conditioning air: not stated
- System of generating test atmosphere: dichlorosilane contained in a gas cylinder, metered through a flow meter and diluted with dry or humidified air
- Treatment of exhaust air: not stated
- Temperature, humidity, pressure in air chamber: see tables

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatograph with hot wire detector
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
1 h
Concentrations:
257, 493, 1000 ppm
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: prior to exposure, Days 7 and 14
- Necropsy of survivors performed: yes
Statistics:
The means and standard deviations of the body weights, body weight changes and exposure concentrations were calculated. No statistical comparisons were made. The LC50 was determined by a modified method of Pinney's (1954) probit analysis.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
314 ppm
Based on:
other: nominal concentration
95% CL:
211 - 466
Exp. duration:
1 h
Mortality:
Mortalities were recorded in all exposure groups except for 257 ppm females (see table).
Clinical signs:
other: Clinical signs observed on the day of exposure included lacrimation, perioral and perinasal wetness, mouth breathing, audible respiration and cloudy eyes. During the post-exposure period decreased motor activity, audible respiration, unkempt fur and perio
Body weight:
A loss of body weight was recorded for all survivors on Day 7, body weight gain was recorded during the second post-exposure week (Days 7 to 14).
Gross pathology:
Gross lesions considered to be exposure-related were noted in animals which died and included red or dark discolouration of the lungs, fluid-filled pleural cavities and trachea, periocular and perinasal encrustation and cloudy eyes. There were no remarkable findings in animals that survived the 14-day observation period.

Any other information on results incl. tables

No dichlorosilane vapour was found in any of the four exposure chamber atmospheres. Water vapour reacted with dichlorosilane quickly and completely in both the low and high relative humidity experiments. The metered (nominal) dichlorosilane concentrations (% relative humidity values) for the four exposures were 1000 ppm (41%), 493 ppm (25%), 493 ppm (80%) and 257 ppm (12%).

Table 1 - Summary of Mortality

Nominal Dichlorosilane Exposure Concentration (ppm)

Exposure Chamber Relative Humidity (%)

Sex

Time of death

Total Incidence

During exposure

Post exposure day

1

2

3

4

8

9

12

1000

41

M

F

0

0

5

5

-

-

-

-

-

-

-

-

-

-

-

-

5/5

5/5

493

25

M

F

0

0

0

0

2

3

2

0

0

1

0

0

0

0

1

0

5/5

4/5

493

80

M

F

0

0

5

4

0

1

-

-

-

-

-

-

-

-

-

-

5/5

5/5

257

12

M

F

0

0

0

0

0

0

0

0

0

0

2

0

1

0

0

0

3/5

0/5

Table 2 - Chamber atmosphere conditions

Nominal Dichlorosilane
Exposure Concentration (ppm)

Temperature (oC)
(Mean ± SD)

Relative Humidity (%)
(Mean ± SD)

1000

493

493

257

25 ± 1

23 ± 0

23 ± 0

23 ± 1

41 ± 15

25 ±11

80 ± 1

12 ± 9

Table 3 - Nominal Exposure Concentrations

Nominal Dichlorosilane
Exposure Concentration (ppm)

Relative
Humidity (%)

Exposure
Duration
(min)

Chamber
Airflow Rate
(L/min)

Dichlorosilane
Flow Rate
(mL/min)

Actual Dichlorosilane
Exposure Concentration (ppm)

1000

493

493

257

41

25

80

12

60

60

60

60

30

50

50

50

30.0

24.7

24.7

12.9

0

0

0

0

Table 4 - Hydrogen Chloride Exposure Concentrations

Nominal Dichlorosilane
Exposure Concentration (ppm)

Relative
Humidity (%)

Mean (±SD) Exposure Conc of Hydrogen Chloride (ppm)

GC Method

Detector Tube Method

1000

493

493

257

41

25

80

12

1050 (± 237)

1880 (± 77)

< 250

320 (± 191)

2300 (± 260)

1870 (± 153)

770 (± 231)

850 (± 71)

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
One hour inhalation whole body exposure to dichlorosilane at nominal concentrations of 257, 493 or 1000 ppm resulted in mortalities at all concentrations and clinical signs consistent with exposure to hydrogen chloride. The LC50 for dichlorosilane was calculated to be 314 ppm (95% confidence limits 211 - 466 ppm). This equates to a 4-hour LC50 of 157 ppm.