Dimethyltin dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 January 1993 - 4 March 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

The relative humidity of the animal room (26-53%) exceeded the range specified in the protocol (40-60%) during this study. These occurrences are considered to have had no apparent impact on the outcome of this study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyltin dichloride

EC Number:

212-039-2

EC Name:

Dimethyltin dichloride

Cas Number:

753-73-1

Molecular formula:

C2H6Cl2Sn

IUPAC Name:

dimethyltin dichloride

Test material form:

not specified

Details on test material:

- Physical state: liquid
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, OH.
- Age at study initiation: NDA
- Weight at study initiation: 2 - 3.5 kg
- Housing: The animals were housed individually in suspended stainless steel cages.
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 was provided ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 70
- Humidity (%): 26 - 53%
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

IN-LIFE DATES: From: 1st March 1993 To: 4th March 1993

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 (4 male, 2 female)

Details on study design:

TEST SITE
- Area of exposure: 1" x 1"
- % coverage: NDA
- Type of wrap if used: Gauze patch held in place at the cut edges with nonirritating tape. An elastic wrap was placed over the trunk and secured at both ends with tape to prevent removal and ingestion of the test material (semi-occlusive binding).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed where practical using gauze moistened with distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The data for each animal was individually analysed based on the definitions presented below:
1. Non-irritant - Any test site that does not exhibit signs of dermal irritation (ex., no erythema and/or edema) following application of the test material.
2. Irritant - Any test site that exhibits reversible inflammatory changes (ex., erythema and/or edema) following application of the test material.
3. Corrosive - Any test site that exhibits irreversible damage (ex., necrosis, ulceration, eschar) following application of the test material.

DERMAL IRRITATION GRADING SYSTEM
(DRAIZE)

ERYTHEMA
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formations (injuries in depth)

EDEMA
0 - No edema
1 - Very slight edema (barely perceptible)
2 - Slight edema (edges of area well defined by definite raising)
3 - Moderate edema (raised approximately 1 mm)
4 - Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Same score for all rabbits at all time points

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hours

Score:

3.94

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Scores the same for all rabbits at all time points, except for one score of 3 in one rabbit at 48 hours. All other scores were 4.

Irritant / corrosive response data:

Exposure to the test material produced necrosis and blanching with severe edema on 6/6 test sites at the 1 hour scoring interval. The dermal irritation progressed to eschar on 3/6 test sites by the 72 hour scoring interval.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, [Di/Mono] Methyltin Chlorides Solution is considered to be corrosive to the dermal tissue of the rabbit.

Executive summary:

The potential irritant and/or corrosive effects of [Di/Mono] Methyltin Chlorides Solution were evaluated on New Zealand White rabbits. Each of six rabbits received a 0.5 ml dose of the test material as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test material was wiped from the skin using gauze moistened with distilled water. Test sites were subsequently examined and scored for dermal irritation for up to 72 hours following patch removal. Exposure to the test material produced necrosis and blanching with severe edema on 6/6 test sites at the 1 hour scoring interval. The dermal irritation progressed to eschar on 3/6 test sites by the 72 hour scoring interval. Under the conditions of this test, [Di/Mono] Methyltin Chlorides Solution is considered corrosive to the dermal tissue of the rabbit.