Bis(tributyltin) oxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

20 July 1970

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The skin of the back, sides and abdomen of the rats were shaved. The compound (TBTO) was sprayed on a skin area averaging 3.8 x 10 cm, usin a Deska compressed air vaporizer and covered with a plastic film and adhesive plaster (Tesaband). After 24 hours the plastic film was removed, the application site washed with luke-warm tap water. The application area was examined again after 4 hours and there after once daily for 8 days.

GLP compliance:

no

Remarks:

Completed before GLP standards, but would have been GLP compliant

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexabutyl di-stannoxane

IUPAC Name:

Hexabutyl di-stannoxane

Constituent 2

Reference substance name:

21955

IUPAC Name:

21955

Details on test material:

Not available

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 88-115 g
- Housing: Caged, Macrolon type II with wire-mesh bottom
- Diet (e.g. ad libitum): Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24 °C
- Humidity (%): 51-56%

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and abdomen
- % coverage: 3.8 x 10 cm area
- Type of wrap if used: plastic film and adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with luke-warm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 10 g in 100 g
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 carboxylmethyl cellulose, aq dest ad 100 mL

Duration of exposure:

24 hours

Doses:

One dose = 300 mg/kg

No. of animals per sex per dose:

10 male & 10 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: once per day
- Necropsy of survivors performed: yes

The following body areas, apertures, cavities and organs were examined by inspection and/or palpation, using appropriate equipment (e.g., hand-lens, stereoscopic microscope, instruments) in the course of assessing the nutritional state and cause of death, in all animals:

(1) Hairy pelt and
(2) Skin
Bodily apertures
(3) Eyes and conjunctiva
(4) Nose
(5) Mouth
(6) Ears
(7) Anus
(8) Preputial aperture
(9) Vulva
(10) Subcut. conn. tissue
(11) Abdominal and
(12) Pelvic cavities and
(13) Peritoneum
(14) Oesophagus*
(15) Stomach
(16) Small intestine
(17) Large intestine
(18) Mesenteric lymph node
(19) Liver
(20) Pancreas
(21) Spleen
(22) Kidneys
(23) Urinary bladder
(24) Seminal vesicles
(25) Prostate
(26) Testes
(27) Epididymides
(28) Ovaries
(29) Uterus
(30) Vagina*
(31) Thoracic cavity and
(32) Pleura
(33) Heart
(34) Lungs
(35) Trachea
(36) Thymus
(37) Cerebrum*
(38) Middle ear
(39) Site of administration

* Only where there is suspicion of pathological change as a result of the toxicity pattern, or other Special pathological findings.
Only pathological changes are recorded, with a note of their localisation, size or quantity, colour, surface area, section surface, consistency and/or diagnosis, in all animals, sub-divided in dose-groups

Statistics:

No information

Results and discussion

Preliminary study:

No information

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Mortality:

None

Clinical signs:

other: Apathy began a few hours after application and persisted to the 4th day. From day 5 onwards, erythema and swelling were observed at the application site. All animals survived a dose of approximately 300 mg/kg. Dry necrosis of the skin was found at the app

Gross pathology:

On male had dry necrosis of skin of back at site of application. Two females had reddish scabbed areas up to the size of a five-penny piece on the ventral skin. Two females had hard and dry ventral skin.

Applicant's summary and conclusion

Conclusions:

LD50 (epidermal) > 300 mg/kg

Executive summary:

The skin of the back sides and abdomen of the rats was shaved. The compound (ZK 21,955 was sprayed on a skin area averaging 3.8 x 10 cm, using a Desaka compressed air vaporizer, and covered with a plastic film and adhesive plaster (Tesaband). A single application at a dose level of 300 mg/kg was applied. After 24 hours, the plastic film was removed, the application site was washed with luke-warm tap water. The application area was examined again after 4 hours and thereafter once daily until day 8. Apathy began a few hours after application and persisted to the 4th day. From day 5 onwards, erythema and swelling were observed at the application site. All animals survived a dose of approximately 300 mg/kg. Dry necrosis of the skin was found at the application site.