Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline; under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
EC Number:
603-837-5
Cas Number:
134605-64-4
Molecular formula:
C20H18ClF3N2O6
IUPAC Name:
1-(allyloxy)-2-methyl-1-oxopropan-2-yl 2-chloro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydropyrimidin-1(2H)-yl]benzoate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: Solid (tan powder)
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: Hra:(NZW)SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: not reported
- Weight at study initiation: 2.719 - 3.119 kg
- Housing: Test animals were individually housed in screen-bottomed stainless steel cages
- Diet (e.g. ad libitum): Certified rabbit diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 50 +/- 20
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

IN-LIFE DATES: From: To: 1995-07-07 to 1995-07-10

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 g

VEHICLE
- No vehicle used, the test material was administered as received.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (observations made at 30 minutes, 24h, 48h and 72h).
Number of animals:
6 females
Details on study design:
TEST SITE
- Area of exposure: The test material was applied to the intact skin site on each animal's back (approximate exposure area of 6.25 cm2).
- % coverage: not reported.
- Type of wrap if used: The area of application was covered with a 2.5-cm X 2.5-cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): patches were removed and the test sites were washed using tap water and disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin.
- Time after start of exposure: After the 4-hour exposure period.

SCORING SYSTEM: based pn the method of Draize.;
- Erythema and Eschar Formation
No erythema 0; Very slight erythema {barely perceptible) 1; Well-defined erythema 2; Moderate to severe erythema 3; Severe erythema {beet redness) to slight eschar formation (injuries in depth) 4
- Edema Formation
Very slight edema (barely perceptible) 0; Slight edema (edges are well defined by definite raising) 1; Moderate edema (raised approximately 1 mm) 2; Severe edema (raised approximately 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
No dermal irritation was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material produced no dermal irritation effects. The test material is considered to be non-irritating to the skin.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The study was performed to GLP and followed the EPA guideline 81-5. The test substance was evaluated in 6 female New Zealand white rabbits. A dose of 0.5 g test substance, moistened with 0.5 mL distilled water, was applied to the intact shorn dorsal skin site under a semi-occlusive dressing for 4 hours. The patch was then removed and the application site was washed to remove residual test material. Skin observations were made 30 minutes, 24, 48 and 72 hours after patch removal.

A single 4-hour, semi-occluded application of the test material to the intact skin produced no irritation effects. The test material produced a primary irritation index (PII) of 0 and is considered to be non-irritating to skin.

Categories Display