4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 13 to 27 Jan 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

EC Number:

915-673-4

Cas Number:

211519-85-6

Molecular formula:

For the substance, C18H42O6SnSi2 (n = 2 – 4) Constituent 1 (S2): C18H42O6S2Si2 Constituent 2 (S3): C18H42O6S3Si2 Constituent 3 (S4): C18H42O6S4Si2

IUPAC Name:

Reaction Mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Test animals

Species:

rat

Strain:

other: outbred Wistar stock, (kfm:Wistar)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, SWITZERLAND
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 229-268 g (males), 217-272 g (females)
- Fasting period before study: apparently none - food withheld during treatment
- Housing: 5/Macrolon type 4 cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

IN-LIFE DATES: From: 1983-01-13 To: 1983-01-27

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: PVC nose-only tube-shaped chambers arranged radially around central chamber.
- Exposure chamber volume: 100 l
- Method of holding animals in test chamber: not stated
- Source and rate of air: dynamic, 10 l/min (operated as described in Sachsse et al 1973 & 1976).
- Method of conditioning air: -
- System of generating particulates/aerosols: test material supplied to spray nozzle by Perfusor R ED 1-300 automatic infusion pump. Air flow 600 l/hr; air pressure 3 atmospheres.
- Method of particle size determination: gravimetric (4-stage cascade impactor on Selectron filter)
- Treatment of exhaust air: -
- Temperature, humidity, pressure in air chamber: 22.5° C (SD 0.4); 57% RH (SD 9)
- Oxygen level: 20 % vol

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric (Selectron filter pore size 0.2 microns)
- Samples taken from breathing zone: not stated

VEHICLE
none

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 46% 1-7 microns (2 measurements)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

7967 mg/m3 (measured) (standard deviation 510)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: mortality and clinical observations 5 times during day 1, then daily; body weights recorded on days 1, 8, 15.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight.

Statistics:

None.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 7 967 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: standard deviation 510 mg/m3

Mortality:

No deaths. See table 1.

Clinical signs:

other: Minor clinical signs reported during day 1. See table 1.

Body weight:

No effect on body weight.

Gross pathology:

No treatment-related effects reported.

Other findings:

None

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and mortality or evident toxicity

Nominal Conc. (ml/h)	Analytical Conc. (mg/m3)	Mean particle size distribution µm	Mortality (males and females/total)	Number with evident toxicity (males and females/total)
60	7967 (SD 510)	46% 1-7	0/10	Day 1: slight dyspnoea, slight exophthalmos or slightly ruffled fur in all exposed animals. Days 2-15: no overt toxicity
0	0	-	no data	-

 SD: standard deviation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study conducted according to OECD Test Guideline 403 but without indication of compliancy to GLP, an LC50 in excess of 7967 mg/m3 in rats exposed for 4 h was identified.