Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

EC Number:

249-616-3

EC Name:

Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

Cas Number:

29420-49-3

Molecular formula:

C4HF9O3S.K

IUPAC Name:

potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot number 2

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature

FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was moistened with 1% carboxymethylcellulose (CMC) in deionized water.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc. Thompson Station, Tenessee
- Age at study initiation: Approximately 12 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals will be individually housed in stainless steel cages. The cages conform to standards set forth in the Guide for the Care and Use of Laboratory Animals, National Academy Press, Washington, D.C., 1996.
- Diet (e.g. ad libitum): Teklad Certified Rabbit Diet #8630 will be provided at approximately 125 grams per day. This diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Results of the manufacturer's analyses are on file at Primedica Redfield.
- Water (e.g. ad libitum): Filtered tap water will be provided ad libitum. Samples of the water are analyzed for totat dissotved solids, hardness, and specified microbiological content, and for environmental contaminants. Results of these analyses are on file at Primedica Redfield.
- Acclimation period: Animals were acclimated for 16 days prior to study day 1.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 C (61-72 F)
- Humidity (%): 30-70%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 hour light:dark cycle

IN-LIFE DATES: From: 24 May 2000 To: 1 June 2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: 1% Carboxymethylcellulose (CMC)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened with 1% carboxymethylcellulose in deionized water)

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 females (nulliparous and non-pregnant)

Details on study design:

TEST SITE
- Area of exposure: Approximately 6 cm2 on the dorsal area of the trunk
- Type of wrap if used: Gauze patch held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm tap water and gauze
- Time after start of exposure: 4 hours post exposure

OBSERVATION TIME POINTS
Dermal scoring at 60 minutes, and then 24, 48, and 72 hours after patch removal

SCORING SYSTEM:
- Method of calculation:Draize scoring method (Draize et. aL 1944, J. Pharmacol. Exptl. Thera. 82:377-390)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 1, 2, and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: Other possible dermal findings

Basis:

animal: 1, 2, and 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

As indicated in all rabbits, 500 mg of T-7485 failed to induce erythema, edema, or other possible dermal findings during the scoring periods.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, application of 500 mg T-7485 is not a skin irritant.

Executive summary:

The primary skin irritation/corrosion potential of T-7485 was evaluated in New Zealand White rabbits. This study was performed in accordance with OECD GLP (1981) and US FDA GLP 21 CFR 58. The study design was based on OECD 404 (year not reported). The hair was clipped from the dorsal skin of three female rabbits. The test material (500 mg T-7458 moistened with 1% carboxymethylcellulose in deionized water) was placed under gauze on the back of each animal and secured with non-irritating tape for a 4-hour exposure. Residual test material was removed with warm tap water and gauze. Observations for skin irritation (erythema and edema) were recorded at time of patch removal and at 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study. The PII was 0.0/8.0. Based on the results of this study, T-7485 is not a skin irritant.