Dibutyltin dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 August - 17 August 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Source and purity of the test substance not reported. Only one animal exposed to test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The local dermal tolerance of ZK 22.663 was tested on the intact skin of 1 male rabbit after a single application under semi-occlusive conditions. One intact skin area (2.5 x 2.5 cm each) was treated with a paste containing 0.5 g ZK 22.633/0.2 mL 0.9% (w/v) NaCl solution for 4 hours whereas the corresponding control area remained untreated. The local reactions were recorded within 30-60 minuts after exposure and thereafter once daily until day 3 of the test.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyltin dichloride

EC Number:

211-670-0

EC Name:

Dibutyltin dichloride

Cas Number:

683-18-1

Molecular formula:

C8H18Cl2Sn

IUPAC Name:

dibutyltin dichloride

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schriever
- Age at study initiation: nda
- Weight at study initiation: 2.8 kg
- Housing: Metal cage
- Diet: pell. Altromin K, ad libitum
- Water: Demineralised water, ad libitum
- Acclimation period: > 2 weeks, feeding during acclimation consisted of a diet containing 0.03% sulfaquin-oxaiine for 7 consecutive days for coccidioses prophylaxis


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24°C
- Humidity (%): 55-57%
- Air changes (per hr): nda
- Photoperiod (hrs dark / hrs light): 12 hours day/night cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: 0.9% (w/v) NaCl solution

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): 0.5g of the test material was moistened with 0.2 ml 0.9% w/v NaCl solution to form a paste.


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 ml 0.9 % w/v NaCl solution

Duration of treatment / exposure:

4 hours

Observation period:

3 days in total; 30 - 60 minutes after exposure, and thereafter every 24 hours till day 3 of the test, clinical observations were made and findings recorded.

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: nda
- Type of wrap if used: Sites were covered with a piece of gauze (semiocclusive) fixed on the skin with Leukoflex®.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the gauze was removed and the treated and untreated skin areas were wiped off carefully with lukewarm tap water and cotton wool
- Time after start of exposure: 30 - 60 minutes after exposure, and thereafter every 24 hours till day 3 of the test, clinical observations were made and findings recorded.


SCORING SYSTEM:
Draize scoring

Results and discussion

In vivo

Results

Irritation parameter:

other: Draize

Basis:

animal #1

Time point:

other: 3 days

Score:

6.3

Reversibility:

no data

Irritant / corrosive response data:

The irritation index according to Draize was 6.3 for the animal, indicative of severe local irritation.

Other effects:

Swellings, reddening, induration, scab formation, vesiculation and beginning of necrosis at the application site.
Macroscopic findings (necropsy) revealed a severe thickening of skin and subcutis and formation of eschar. Further a wet cut surface of the skin was observed.

Any other information on results incl. tables

It should be taken into consideration that the rabbit skin has proved to be more sensitive towards tributyltin compounds in former studies compared with human's skin. Thus, although skin necrosis might not be expected, less severe alterations like reddening and swelling might occur after inadvertent contact of the test material with the human skin.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

The irritation index according to Draize was 6.3 for this animal, indicating severe irritation.

Executive summary:

In a local dermal tolerance test in rabbits after a single application (Schering report number: IC 29/89) the test material was found to be severely irritation according to the draize score of 6.3.

Application of the test material led to swellings, reddening, induration, scab formation, vesiculation and beginning of necrosis at the application site.

Macroscopic findings (necropsy) revealed a severe thickening of skin and subcutis and formation of eschar. Further a wet cut surface of the skin was observed.