Bis(tributyltin) oxide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Analytical exposure concentrations were deemed to be unreliable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Male Wistar-Han rats (5 per group) were exposed to TBTO as a vapour for a 10 day continuous exposure (24 hours/day). The animals were observed for clinical signs, mortality, changes to body weight and a for gross pathological and histopathological changes at necropsy.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(tributyltin) oxide

EC Number:

200-268-0

EC Name:

Bis(tributyltin) oxide

Cas Number:

56-35-9

Molecular formula:

C24H54OSn2

IUPAC Name:

tributyl[(tributylstannyl)oxy]stannane

Details on test material:

Batch No. 193086
Product was stabilzed agains decomposition by light

Test animals

Species:

rat

Strain:

other: Wistar Han

Sex:

male

Details on test animals or test system and environmental conditions:

Source: Schering AG
Randomized by lot and ear/tail marked
Acclimatisation > 7 days.
Body weight at beginning of treatment 135-168 g
Housing: macrolon cages
Environment: 12 h light dark cycles
Diet: pelleted feed (Altromin R) and tap water ad libitum

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Dried compressed air was passed through fine particle filter, pressure stabilizer, regulator and flow meter at a rate of 200 L/h at 20C, 760 torr. Air was then led over lime for removal of CO2 and washing bottle with water for humidification. Subsequently the air was led through 2 special gas washing bottles (70 mm diameter) with D1 sintered frits (d-48 mm) connected in series which were filled with the test material at a height of 20 mm only to reduce formation of froth and kept at 20 °C. Air, now enriched with TBTO vapour, was directed via a safety flask to an online fibre glass filter to remove aerosol particles. Filtered vapour air mixture was led to the tubular inhalation chamber

Analytical verification of test atmosphere concentrations:

yes

Remarks:

2.4-12.6 µg/m³ (considered to be unreliable and further studies required for determination of chamber concentration)

Duration of exposure:

24 h

Remarks on duration:

for 10 days

Concentrations:

2.4-12.6 µg/m³

No. of animals per sex per dose:

5 males per group

Control animals:

yes

Details on study design:

- Frequency of observations and weighing: checked twice daily, weighed at the beginning and end of the 10 d exposure period
- Necropsy of survivors performed: all animals sacrificed
- Other examinations performed: clinical signs, body weight ,organ weights (iliac lymph node, spleen, liver, thymus), histopathology (respiratory tract, liver, spleen, thymus, iliac lymph node and mesenteric lymph node.

Results and discussion

Mortality:

None

Clinical signs:

other:

Body weight:

No effect

Gross pathology:

No effects

Other findings:

Organ weights: no effects other than individual anomalies
Histopathology: no effects - in particular no irritation of respiratory tract or an atrophy of lymphoid organs

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, no effects were reported

Executive summary:

A group of 5 male Wistar-Han rats was exposed continuously for 10 days (whole body exposure) to an atmosphere enriched with vapour of ZK 21,955 (TBTO). The concentration of the test compound could not be determined reliably. A sham-treatment group inhaled air only under otherwise same conditions. In the exposure chamber, all animals had free access to tap water and a pelleted diet. The effects of exposure were investigated by means of general observations, necropsy, organ weight analysis of the liver and the lymphatic organs and by microscopic examination of the given organs as well as of the respiratory tract (nose, pharynx, trachea, lungs). No definite effects of the exposure to ZK 21.955 were noted.