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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 August 1977 to 22 August 1977
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:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
fixed concentration procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
EC Number:
247-666-0
EC Name:
Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate
Cas Number:
26401-97-8
Molecular formula:
C36-H72-O4-S2-Sn
IUPAC Name:
6-methylheptyl 14-methyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannapentadecan-1-oate
Constituent 2
Reference substance name:
Mono-n-octyltin-tri-thioglycol-acid isooctyl ester
IUPAC Name:
Mono-n-octyltin-tri-thioglycol-acid isooctyl ester
Test material form:
liquid
Details on test material:
- Appearance: colourless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In house
- Weight at study initiation: 150 to 168 g (M) and 133 to 147 g (F)
- Fasting period before study: 16 hours before treatment
- Housing: Macrolon Type II cages, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 to 23°C
- Humidity: 49 to 65 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
- The dynamically operated inhalation system consists of the generator unit for generating the inhaled air saturated with test material vapour and the exposure unit for the absorption and exposure of the test animals.
- The compressed air of the household network was passed through two parallel special gas washed bottles after passing through a fine dust filter, pressure stabiliser, volume regulator and volume meter. These washed bottles were each equipped with G1 glass frits.
- The filling quantity of the special gas washed bottles over the frit was kept constant by means of a level control. The washed bottles as well as a glass tube coil for temperature pre-stabilisation of the air were in a temperature-controlled water bath in which had a temperature of 20 ± 0.2°C was maintained.
- After leaving the gas washed bottles, the steam was now saturated with test material steam. Air passed into two tube-shaped inhalation chambers.
- These inhalation chambers consisted of a glass tube (diameter 150 mm, length 1000 mm) with detachable end pieces and an insertable grid frame, which subdivided the upper part of the glass tube into 10 segments (1 animal per segment). The grid frame was resting on a half-blade made of stainless steel for excrement recording. The air / steam mixture emanating from the chambers was passed into the flue.
- The temperature and relative humidity in the chambers were monitored.

Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
- Air was saturated with the test material
No. of animals per sex per dose:
10 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- A relative humidity of 13% and a temperature of 20 to 21°C were measured in the chambers.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Remarks on result:
other: When the air was saturated with the test material for a 7 hour treatment period, no mortality occurred.
Mortality:
No deaths occurred during the exposure or observation period.
Clinical signs:
other: In the 14-day observation period some animals showed conjunctivitis
Body weight:
- Group 1: Male mean body weight increased from 164 to 278 g during the study and female mean bodyweight increased from 139 to 199 g.
- Group 2: Male mean body weight increased from 158 to 275 g during the study and female mean bodyweight increased from 140 to 200 g.
Gross pathology:
All male and female animals were suspected of slight thymus enlargement, which however can neither be quantified nor interpreted as a test material defect, since no control group was carried in the experiment.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of this study following a 7 hour treatment, no mortality occurred. In some animals, a temporary conjunctivitis was observed during the post-treatment period.
Executive summary:

The acute inhalation toxicity of the test material was investigated in a study using male and female Wistar rats.

Animals whole bodies were continually exposed to the test material at steam saturated in air for a period of 7 hours in an inhalation chamber. They were observed during this treatment time and for 14 days afterwards.

No mortalities occurred during the treatment or observation periods. Some of the animals showed conjunctivitis during 14-day observation period. Body weights increased during the observation period.

Following the 14 days observation period the animals were sacrificed and necropsy performed. All animals were suspected of slight thymus enlargement, which however can neither be quantified nor interpreted as a test material defect, since no control group was carried in the experiment.

Under the conditions of this study following a 7 hour treatment, no mortality occurred. In some animals, a temporary conjunctivitis was observed during the post-treatment period.