Chlorotrioctylstannane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male and female rats were exposed to the test material as an aerosol mist for 4 hours.

GLP compliance:

no

Remarks:

Study conducted in 1974, prior to inception of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chlorotrioctylstannane

EC Number:

219-969-8

EC Name:

Chlorotrioctylstannane

Cas Number:

2587-76-0

Molecular formula:

C24H51ClSn

IUPAC Name:

chlorotrioctylstannane

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: 54 Tif. RAI (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bred in-house at the testing facility
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: 175 to 185 g (male and female)
- Housing: The male and female rats were segregated (9 animals to a cage) during observation period

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: Approximately 50 % (relative)

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The exposure system used in the test was that described by Sachsse et al., 1974 (Sachsse K, Ullmann L, Voss G & Hess R: Measurement of inhalation toxicity of aerosols in small laboratory animals. Proceedings of the European Society for the study of Drug Toxicity Volume XV, 239, 1974). The animals were not exposed until the aerosol was evenly dispersed throughout the chamber (15 minutes).
- Method of holding animals in test chamber: The test animals were kept in separate PVC tubes positioned radially around the exposure chamber.
- Source and rate of air: The test material was sprayed into the exposure chamber by means of a pressure nozzle. The liquid was injected by a motor-driven syringe at a rate of 0.9, 3 and 12 mL/hr into a stream of compressed air (2 atm.) flowing through a spray nozzle at a rate of 10 L/min. The aerosol mist thus produced was discharged into the exposure chamber.
- Method of particle size determination: Gravimetrically

TEST ATMOSPHERE
- Brief description of analytical method used: The particle-size distribution in the aerosol was determined gravimetrically on Selectron-Filters, pore size 0.2 µm every hour with the aid of a Cascade Impactor (C.T. Casella and Co., Ltd).
- Samples taken from breathing zone: Yes. The aerosol in the immediate vicinity of the animals was sampled on membrane filters, pore size 0.2 µm (Satorius) hourly after the beginning of the test.

VEHICLE
- Concentration of test material in vehicle: 92, 224 and 718 mg/m³

TEST ATMOSPHERE
- At 92 mg/m³ the mean particle size distribution was 44, 19, 21 and 16 % of the particles >7, 3 to 7, 1 to 3 and <1 µm, respectively.
- At 224 mg/m³ the mean particle size distribution was 59, 16, 20 and 5 % of the particles >7, 3 to 7, 1 to 3 and <1 µm, respectively.
- At 718 mg/m³ the mean particle size distribution was 55, 14, 24 and 7 % of the particles >7, 3 to 7, 1 to 3 and <1 µm, respectively.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

92, 224 and 718 mg/m²

No. of animals per sex per dose:

9 animals per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Clinical signs were recorded throughout the 7 day observation period.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

ca. 250 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

All of the 18 rats (9 male and 9 female) that were exposed to the lowest concentration of test material, 92 mg/m³, survived.
Three male and three female rats died between 24 and 48 hours after being exposed to the median test material concentration of 224 mg/m³. A further male rat died prior to the end of the 7 day observation period.
At the highest concentration of test material, 718 mg/m³, all 9 male and all 9 female rats had died within 24 hours of exposure.

Clinical signs:

other: After the 4-hour exposure the rats in concentrations where mortalities occurred (224 mg/m³ and 718 mg/m³) showed signs of dyspnoea, lateral position, cyanosis, apathy and ruffled fur. These symptoms became more accentuated as test material concentration i

Gross pathology:

Haemorrhages in the lungs and congested organs were observed in the animals that died during the study. In those that were sacrificed after the 7 day observation period, no test material related gross organ changes were seen.

Any other information on results incl. tables

Table 1: Mortality Results

Concentration (mg/m³)	Exposure time (hours)	No. of Animals		Died within
				0 - 4 hours		24 hours		48 hours		7 days
		M	F	M	F	M	F	M	F	M	F
92	4	9	9	0	0	0	0	0	0	0	0
224	4	9	9	0	0	0	0	3	3	4	3
718	4	9	9	0	0	9	9	9	9	9	9

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 in accordance with EU criteria

Conclusions:

Under the conditions of the study, the LC50 of the test material was found to be 250 mg/m³ (0.25 mg/L) in male and female rats.

Executive summary:

The acute inhalation toxicity of the test material was investigated in a study which was conducted in accordance with generally accepted scientific principles.

During the study, the test material was administered to three separate groups of albino rats, each group comprised of 9 males and 9 females. The rats were exposed to the test material for a period of 4 hours, via nose-only exposure, as an aerosol mist at concentrations of 92, 224 and 718 mg/m³. The individual concentrations of the test material were gravimetrically determined.

The exposure system used in the study was that described by Sachsse et al. (1974); the test material was sprayed into the exposure chamber by means of a pressure nozzle. The liquid was injected by a motor-driven syringe at a rate of 0.9, 3 and 12 mL/hr into a stream of compressed air (2 atm.) flowing through a spray nozzle at a rate of 10 L/min. The aerosol mist thus produced was discharged into the exposure chamber.

All of the 18 rats (9 male and 9 female) that were exposed to the lowest concentration of test material, 92 mg/m³, survived. Three male and three female rats died between 24 and 48 hours after being exposed to the median test material concentration of 224 mg/m³. A further male rat died prior to the end of the 7 day observation period. At the highest concentration of test material, 718 mg/m³, all 9 male and all 9 female rats had died within 24 hours of exposure.

The rats in concentrations where mortalities occurred (224 mg/m³ and 718 mg/m³) showed signs of dyspnoea, lateral position, cyanosis, apathy and ruffled fur. These symptoms became more accentuated as test material concentration increased. The surviving animals had recovered within 4 to 5 days. 

Haemorrhages in the lungs and congested organs were observed in the animals that died during the study. In those that were sacrificed after the 7 day observation period, no test material related gross organ changes were seen.

Under the conditions of the study, the LC50 of the test material was found to be 250 mg/m³ (0.25 mg/L) in male and female rats.