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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Analytical exposure concentrations were deemed to be unreliable

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
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:

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(tributyltin) oxide
EC Number:
EC Name:
Bis(tributyltin) oxide
Cas Number:
Molecular formula:
Details on test material:
Batch No. 193086
Product was stabilzed agains decomposition by light

Test animals

other: Wistar Han
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
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:
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
2.4-12.6 µg/m³
No. of animals per sex per dose:
5 males per group
Control animals:
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

Clinical signs:
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
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.