4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 December 1997 - 13 January 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed in a GLP laboratory.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-400-4

EC Name:

-

Cas Number:

181696-73-1

Molecular formula:

C16H15NO2

IUPAC Name:

4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): SC-66285

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Kalamazoo, Michigan
- Age at study initiation: 14-18 weeks of age
- Weight at study initiation:

ANIMAL; SEX; Pre-Dose Weight (g)
F65378; F; 2,356
F65379; F; 2,500
F65381; F; 2,302
F65354; M; 2,574
F65383; F; 2,642
F65356; M; 2,409

After receipt, the animals were acclimated for a period of at least 7 days. During acclimation and throughout the study, the animals were individually housed in suspended, stainless steel cages. Environmental controls for the animal room were set to maintain a temperature of 16° to 22°C, a relative humidity of 50% ±20%, and a 12-hour light/12-hour dark cycle. In cases where variations from these conditions existed, they were documented and considered to have had no adverse effect on the study outcome.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

water

Remarks:

Test area was moistened with 0.8 ml of distilled water prior to application.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g in 0.8 ml of water (used to moisten the test area)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 rabbits

Details on study design:

Untreated
TEST SITE
- Area of exposure: 2.5 cm x 2.5 CM
- Type of wrap if used: Seran Wrap and Elstoplast tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours from initiation of treatment.

SCORING SYSTEM:
Draize Scoring System:
(1) Erythema and Eschar Formation
No erythema...........................................................................O
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
Highest possible erythema score .4

(2) Edema Formation
No edema.......................................................................O
Very slight edema (barely perceptible).........................................1
Slight edema (edges are well defined by definite raising)......................2
Moderate edema (raised approximately 1 mm) :...................................3
Severe edema (raised approximately 1 mm and extending beyond area of exposure).4
Highest possible edema score............ 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 0.2

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 hours

Score:

ca. 0

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Irritant / corrosive response data:

Reversible effects were observed in one female animal. The effects were fully reversible within a 24 hour period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Under the conditions of this test, SC-66285 is considered to be nonirritating to dermal tissue of the rabbit.

Executive summary:

The test substance is determined not to be a skin irritant under the conditions of this test.