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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:
from 13 to 27 Jan 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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

Constituent 1
Chemical structure
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:
C18H42O6SxSi2
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
Constituent 2
Reference substance name:
polysulfides
IUPAC Name:
polysulfides

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 wk (males), 12 wk (females)
- Weight at study initiation: 229-268 g (males), 217-272 g (females)
- Fasting period before study: apparently none - food witheld during treatment
- Housing: 5/macrolon type 4 cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 wk

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 deg 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
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 7 967 mg/m³ air (analytical)
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 exophthalamos or slightly ruffled fur in all exposed animals.

Days 2-15: no overt toxicity 

0

0

-

no data

-

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study conducted in compliance with the standard guideline but without GLP status, identified an LC50 in excess of 7967 mg/m3 in rats exposed for 4 h.