Perfluamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 March 1994- 29 April 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study does not indicate adherence to GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

T-5912

IUPAC Name:

T-5912

Details on test material:

- Name of test material (as cited in study report): T-5912
- Substance type: clear, colorless liquid
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP, Inc., Kalamazoo, MI
- Age at study initiation: adult
- Weight at study initiation: 2653-3134 grams
- Sex: female
- Housing:-Diet (e.g. ad libitum): ad libitum (to a fixed amount)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): contrlled
- Air changes (per hr):not stated
IN-LIFE DATES: From: 28 March 1994 To: 31 March 1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin used as a comparison

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 animals/sex/dose

Details on study design:

TEST SITE
- Area of exposure: approx. 6.25 square cm
- Type of wrap if used: test area covered with a 2.5 squared centimeter guaze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with Elastoplast tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water and disposable paper towels.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize method (1959)

Results and discussion

In vivo

Results

Irritation parameter:

other: average primary dermal irritation scores (total dermal irritation score for all animals (erythema and edema) divided by the number of test sites at each observation period.

Basis:

mean

Time point:

other: 4 , 24, 48, 72 hours (the 4 hour observation was made 30 minutes after the removal of the test article after 4 hours of exposure)

Score:

0

Max. score:

0

Reversibility:

no data

Irritant / corrosive response data:

0% of animals displayed any dermal response

Any other information on results incl. tables

All edema and erythema scores for all time points were 0.

Applicant's summary and conclusion

Conclusions:

Application of T-5912 to the skin of rabbits under 4-hour semioccluded conditions resulted in no dermal irritation.

Executive summary:

The primary skin irritation/corrosion of a test material on rabbits under semioccluded conditions was assessed in female New Zealand White rabbits. The test material (0.5 mL) was applied to intact skin on each animal's back and covered with a gauze patch secured with paper tape, loosely overwrapped with plastic, and secured with Elastoplast tale to provide a semiocclusive dressing. After 4 hours, the patches were removed and the test sites cleaned with water. Edema and Erythema scores (using the Draize technique) were observed at 4 hours (30 min after removal of test substance), 24, 28 and 72 hours after the removal of the test material. Untreated skin was used as a comparison, and at the end of the experimental phase, all animals were euthanized. All erythema and edema scores were 0 and Application of T-5912 to the skin of rabbits under 4-hour semioccluded conditions resulted in no dermal irritation.