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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 17, 2011 to August 26, 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according OECD Guideline 404 and OPPTS 870.2500, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-phenyl-5-(2-thienyl)-1,2,4-oxadiazole
EC Number:
810-533-8
Cas Number:
330459-31-9
Molecular formula:
C12H8N2OS
IUPAC Name:
3-phenyl-5-(2-thienyl)-1,2,4-oxadiazole
Test material form:
other: Cream coloured solid
Details on test material:
- Name of test material (as cited in study report): MON 102100

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Robinson Services Inc.
- Age at study initiation: Young adult
- Housing: Singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet® #2031
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 62-75%
- Air changes (per h): 12
- Photoperiod (h dark / h light): 12 h light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Test substance was moistened with distilled water to achieve a dry paste by preparing a 65% w/w mixture
- Amount(s) applied (volume or weight with unit): Five tenths of a gram of the test substance (0.77 g of test mixture)
Duration of treatment / exposure:
4 h
Observation period:
At approximately 30 - 60 min, 24, 48, and 72 h after patch removal.
Number of animals:
2 males and 1 female
Details on study design:
PREPARATION AND SELECTION OF ANIMALS
- On the day before application, a group of animals were prepared by clipping the dorsal area and the trunk. On the day of dosing, but prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy naive animals (not previously tested) without pre-existing skin irritation were selected for test.

TEST SITE
- Area of exposure: 6 cm2 intact skin
- Type of wrap if used: 0.77 g of test mixture was applied to a 1 inch x 1 inch 4 ply gauze pad and placed on one 6 cm2 intact dose site on each animal. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3 inch micropore tape to avoid dislocation of the pad.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently cleansed with 3% soap solution and a water
- Time after start of exposure: 4 h

SCORING SYSTEM: Individual dose sites were scored according to the Draize Primary Skin Irritation Scoring System at approximately 30 - 60 min, 24, 48, and 72 h after patch removal. Additionally, the average erythema and oedema scores across 24, 48 and 72 h for each animal were calculated for EEC2 classification.

0 Non irritant

> 0 - 2.0 Slightly irritant

2.1 - 5.0 Moderately irritant

> 5.0 Extremely irritant

All animals were observed for signs of gross toxicity and behavioural changes at least once daily during the test period.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
There was no dermal irritation observed at any treated dose site during the study.
Other effects:
All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was considered to be non-irritating to the skin.
Executive summary:

A study was conducted to assess the skin irritation potential of the test substance after a single topical application in rabbits according to OECD Guideline 404 and OPPTS 870.2500, in compliance with GLP. 0.77 g of the test substance moistened with distilled water was applied to a 1 inch x 1 inch, 4 ply gauze pad and placed on 6 cm2intact dose sites on three healthy rabbits. After 4 h of exposure, the test sites were gently cleansed with 3% soap solution and water. The skin reactions were assessed and recorded at approximately 30 - 60 min, 24, 48 and 72 h after patch removal. Additionally, the average erythema and oedema scores across 24, 48 and 72 h for each animal were calculated for EEC classification. All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. The primary dermal irritation index for test substance was 0. There was no dermal irritation observed at any treated dose site during the study. Under the conditions of this study, the test substance was considered to be non-irritating to the rabbit skin (Durando J, 2011c).