[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01.12.1981 to 17.12.1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

EC Number:

219-784-2

EC Name:

[3-(2,3-epoxypropoxy)propyl]trimethoxysilane

Cas Number:

2530-83-8

Molecular formula:

C9H20O5Si

IUPAC Name:

trimethoxy[3-(oxiran-2-ylmethoxy)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: Charles River Breeding Laboratories, New York.
- Age at study initiation: 9-11 weeks
- Weight at study initiation: Not defined
- Fasting period before study: No data
- Housing: Individually in suspended wire mesh-bottom exposure cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Four weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71-73 (22-23 °C) 
- Humidity (%): 69-78
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 01.12.1981 To: 17.12.1981

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass exposure chamber.
- Exposure chamber volume: 225 litre.
- Method of holding animals in test chamber: none
- Source and rate of air: Room air. Flow rate of 50 l/minute.
- Method of conditioning air: No data.
- System of generating particulates/aerosols: Spraying Systems 1/4 (?) J Nebulizer.
- Method of particle size determination: cascade impaction.
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: Temperature (°F): 71-73 (22-23 °C); Humidity (%): 69-78.


TEST ATMOSPHERE
Mass median aerodynamic diameter was determined hourly by cascade impaction for each exposure level and ranged from 1.4 to 2.0 microns.  

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric methods and gas chromatography (considered secondary due to recovery inefficiencies, however, gas chromatographic values averaged 85% of the gravimetrically determined concentrations).

Duration of exposure:

4 h

Concentrations:

0.8, 1.9, and 5.3 mg/L

No. of animals per sex per dose:

30

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily observations. Weighing on 1, 2, 4 or 5, 7 and 14 days after exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: gross necropsy.

Statistics:

No details.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.3 mg/L air

Exp. duration:

4 h

Mortality:

No deaths occurred at the two lower concentrations (1.9 and 0.8 mg/L).  At the highest concentration (5.3 mg/L), three rats died, one male on day 1, one female on day 1 and one female on day 2. 

Clinical signs:

other: Following exposures, all rats exhibited varying amounts of test substance contamination on the fur.  Clinical signs included excessive lacrimation, dry and moist rales, nasal discharge, and yellow staining in the anal-genital area.  These signs were consi

Body weight:

There was also a transient dose-related body weight depression seen in all groups (including the control) during the first week, however, mean body weights exceeded pre-exposure values by day 14 in all groups.

Gross pathology:

Discoloured lungs and autolytic changes were seen in the three rats that died.  There were no gross abnormalities noted at the necropsy of survivors.

Any other information on results incl. tables

Table of concentrations and particle sizing data of Prylog (mg/l and µm)

Group	Method	Mean conc./mean MMD	Hourly air samples mg/l/MMD				Nominal conc.
			1	2	3	4
1	Analytical	4.8	4.0	4.9	5.2	4.9	25.3
	Gravimetric	5.3/1.9	5.7/2.0	5.4/1.8	5.4/1.8	4.7/1.8
2	Analytical	1.7	1.7	1.8	1.8	1.4	7.1
	Gravimetric	1.9/1.7	0.9/1.7	2.5/1.6	2.1/1.6	2.0/1.7
3	Analytical	0.6	0.7	0.6	0.6	0.6	2.3
	Gravimetric	0.8/2.0	1.1/1.6	0.7/1.5	0.7/1.4	0.6/1.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a good quality acute inhalation study (reliability score 1) conducted to OECD 403, and GLP, an aerosol of unchanged [3-(2,3-epoxypropoxy)propyl]trimethoxysilane gave an LC50 greater than 5.3 mg/l in rats.

Executive summary:

In a good quality acute inhalation study (reliability score 1) conducted to OECD 403, and GLP, an aerosol of unchanged [3-(2,3-epoxypropoxy)propyl]trimethoxysilane gave an LC50 greater than 5.3 mg/l in rats.