Trichloro(propyl)silane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-06-27 to 1997-07-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

exposure time: 1 hour

GLP compliance:

yes

Test type:

other: whole body inhalation

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(propyl)silane

EC Number:

205-489-6

EC Name:

Trichloro(propyl)silane

Cas Number:

141-57-1

Molecular formula:

C3H7Cl3Si

IUPAC Name:

trichloro(propyl)silane

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not stated
- Age at study initiation: approx. 5-6 weeks
- Weight at study initiation: approx. 75-100g
- Housing: individually in suspended stainless steel, wire mesh bottom cages,
- Diet (e.g. ad libitum): Purina Certified Rodent Chow
- Water (e.g. ad libitum): via automatic watering system
- Acclimation period: one week prior to initiation of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-78°F
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

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: PVC and plexiglas whole body chamber
- Exposure chamber volume: 175 liter
- Source and rate of air: room air, 45 air changes per hour
- Method of conditioning air: filtered (HEPA and activated carbon)
Test article was introduced into the camber through a special designed stainless steel J-tube containing stainless steel beads and wrapped with heating tape and insulation to facilitate vaporization of test article. The test article was metered from a reservoir into J-tube by a Fluid Metering, Inc. pump. Dry air (Michigan Airgas, Zero Grade) flowed through the J-tube at a controlled rate and air/vapour mixture passed into the inlet port at the top of the chamber where it was mixed with chamber supply air prior to introduction into the chamber.
- test atmosphere monitoring:
1. measuring the chloride ion concentration at the end of the delivery stream from the J-tube with an electrolytic conductivity detector (The chloride equivalents calculated for the nominal concentration of the test article were compared with the level of chloride equivalents at the end of the delivery stream from the J-tube).
2. a Hewlett Packard 5890 gas chromatograph (GC) /5972 mass spectrometer (MS) to monitor the test article concentration in the chamber and provide MS analysis of the chamber atmosphere.
- Temperature, humidity, air flow in chamber: 20.3-21.1 °C, 31.5-33%, 129.7-131.0 LPM,
- Nominal concentration:
the amount of test concentration was determined by pre- and post-exposure weight of the test article in the reservoir. The exposure duration, test article used, and volume of air passing through the chamber were used to calculate nominal concentration values.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

GC/MS

Duration of exposure:

1 h

Concentrations:

nominal concentration: 1123; 1317; 1414 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 observations and weighing:
clinical signs: once per day for 14 days following exposure (including respiratory, behavioural, nasal and/or ocular changes.
mortality/morbidity: twice daily on weekday, once on weekends/holidays
body weight: prior to exposure, on day 1, 8, and 15
gross pathology: all animals that died during the study or at the end of 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

LC50, 95% fiducial limits, and approx. slope of dose response curve were calculated using a SAS/STAT probit program. Body weight means and SD were also calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1 352 ppm

Based on:

test mat.

95% CL:

> 1 254 - < 1 455

Exp. duration:

1 h

Mortality:

at 1123 ppm: all animals survived until the end of the 14-day observation period.
at 1317 ppm: 4 animals (2 males, 2 females) died by study day 5.
at 1414 ppm: 7 animals ( 3 males, 4 females) died by study day 4.

Clinical signs:

other: Respiratory, activity, ocular and nasal effects and facial and body soiling were noted in all groups during 14-day observation period. Respiratory effects noted included laboured breathing and rales. The activity effects which were most frequently noted i

Body weight:

Mean body weights for all the groups were depressed at the end of the first week. All surviving animals except for the one female in group 3, gained weight by the end of the 14-day observation period.

Gross pathology:

Test article-related effects observed included corneal opacities, exphthalmos, buphthalmose, and alopecia, lung, nasal, and eye effects. Discoloration of hair were observed in a majority of the animals that died during 14-day observation period. Lung effects noted in these animals included haemorrhage, congestion, and/or consolidation and ectasia.The primary nasal effect was obstructed nostrils. The primary eye effect observed was crusted shut eyelids. Discoloration of the hair was mostly due to porphyrin and greenish staining. Discoloration of the extremities and congestion of the meningeal vessels was noted in a majority of the animals to 1414 ppm that died during the study. Blood in the gastrointestinal tract was noted in few of the animals exposed to 1414 ppm that died during the study. Gaseous distension and a decrease or absence of body fat was noted in a majority of the animals exposed to 1317 that did not survive the observation period.

Other findings:

The nominal exposure concentrations were significantly higher than the measured chamber test article concentrations (394, 440, 510 ppm, respectively) due to the reactivity and hydrolysis of the test article.

Any other information on results incl. tables

                                                    Summary of Mortality data

 

Exposure Group	Nominal Exposure Concentration (ppm)	Number Dead /Number Exposed        Males                Females	Males / Females        Combined
1	1123	0/5                      0/5	0/10
2	1317	2/5                      2/5	4/10
3	1414	3/5                      4/5	7/10

 

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

A reliable study conducted according to OECD and in accordance with GLP, identified a 1h acute inhalation LC50 value of 1352 ppm in male and female rats.