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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Analytical purity: 94.8 %
- Composition of test material, percentage of components: monomethyltin (ethylhexylthioglycolate) 94.8 %; dimethyltin (ethylhexylthioglycolate) 2.1 %
- Purity test date: June 30, 2006
- Lot/batch No.: 51VOC389
- Expiration date of the lot/batch: June 30, 2009
- Storage condition of test material: dry, cool, ventilated area

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 4 months
- Weight at study initiation: 3.0 to 3.8 kg
- Housing: housed 1/cage in suspended wire cages
- Diet (e.g. ad libitum): PMI rabbit chow provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): averaged 21 °C
- Humidity (%): 60 to 82 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle


IN-LIFE DATES: From: 06/20/2006 To: 06/23/2006

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site

VEHICLE no vehicle used
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10 x 10 cm
- Type of wrap if used: piece of fabric (semiocclusive) secured with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with paper towels saturated with tap water and blotted dry with paper towels
- Time after start of exposure: 4 hours

SCORING SYSTEM: A modified Primary Irritation Index was calculated by adding the mean erythema and edema scores at the 60 minute after removal of wrappings, 24, 48 and 72 hour scoring intervals, and dividing by the number of evaluation intervals (4).
Erythema and Eschar
0: No erythema
1: Very slight erythema (barely perceptibe)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1.0 mm)
4: Severe oedema (raised more than 1.0 mm, extending beyond the area of exposure)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.25
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Erythema was absent to very slight at 60 minutes and 24 hours after patch removal and absent at 48 and 72 hours. There was no oedema noted at any observation period.
Other effects:
There were no abnormal physical signs noted during the observation period.
All body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
A modified primary mean irritation score of 0.25 was determined in this study.
Executive summary:

To determine the irritant or corrosive effects, if any, of the test substance when applied dermally, a study following OECD Guideline Number 404 was performed.

Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (females) were dosed dermally with the test substance. The test article (0.5 mL) was applied dermally to one intact site/rabbit. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at termination. A modified Primary Irritation Index was calculated using the 60 minute, 24, 48 and 72 hour scoring intervals.

Erythema was absent to very slight at 60 minutes and 24 hours after patch removal and absent at 48 and 72 hours. There was no oedema noted at any observation period.

There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

The study authors concluded that the substance is not a dermal irritant.