2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 December 1991 to 08 December 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

T-5452

IUPAC Name:

T-5452

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report: T-5452
- Substance type: Colorless liquid
- Physical state: Liquid
- Storage condition of test material: Stored at room temperature

Test animals

Species:

rabbit

Strain:

other: Hra: (NZW) SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male
- Source: Hazleton Research Products, Inc., Kalamazoo MI, U.S.A.
- Age at study initiation: No data.
- Weight at study initiation: 2292-2326 g.
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): High Fiber Riabbit Chow #5326, Purina Mills, Inc., ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-23.9
- Humidity (%): 41-53
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 December 1991To: 08 December 1991

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm by 2.5 cm.
- % coverage: No data
- Type of wrap if used: Saran Wrap (semiocclusive dressing).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed immediately after 4 hour exposure.
- Time after start of exposure: 4 hours after exposure.
SCORING SYSTEM: Draize technique.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4, 24, 48, and 72 hours.

Score:

ca. 0

Reversibility:

fully reversible

Remarks on result:

other: No erythema or edema was observed at any time point in any animal after exposure to the test article.

Irritant / corrosive response data:

No erythema or edema was observed at any time point in any animal after exposure to the test article.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No erythema or edema was observed at any time point in any animal after exposure to the test article. The test article is considered non-irritating to the skin under the conditions of this study.

Executive summary:

A primary dermal irritation study (OECD Guideline 404) was conducted using three albino rabbits (New Zealand White strain). Each rabbit received a 0.5 milliliter applications of the test article to an intact skin test site. The test sites were covered with a semi-occlusive dressing for 4 hours and washed after test article removal. The sites were evaluated for irritation immediately after test article removal (4 hour), 24, 48 and 72 hours. Application of the test article to the skin of albino rabbits under 4 hour semi-occluded conditions resulted in no dermal irritation. An average primary dermal irritation score of 0.0 of a possible 8.0 was assigned at all evaluations. The test article is considered non-irritating to the skin under the conditions of this study.