1-[5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]ethanone

Skin irritation / corrosion

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:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF 12-Nousan-8147 (2000)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

- Purity: 99.9%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3 animals; 2156, 2328 and 2304 g
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 59-69%
- Air changes (per hr): 12 to 13/hr
- Photoperiod: 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Controls:

no

Amount / concentration applied:

Five-tenths of a gram of the test substance (0.83 g of the test mixture) was applied as a dry paste (60% w/w mixture in distilled water)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: one 6-cm2 intact dose site on each animal
- Type of wrap if used: test mixture was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to 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): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or oedema was observed in any animal.

Other effects:

All animals appeared active and healthy and gained weight during the study. There were no clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There was no dermal irritation observed at any treated dose site during the study.

Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application.

At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance, moistened with distilled water, was applied to a patch and then to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al. immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

There was no dermal irritation observed at any treated dose site during the study.