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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.