1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methylbutane-1-sulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 October 2001 to 02 November 2001

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:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 2

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-7599

IUPAC Name:

T-7599

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report):T-5499
- Physical state: White powder
- Analytical purity: >99.9 percent 1-Butanesulfonamine, 1, 1, 2, 2, 3, 3, 4, 4, 4,-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl- and <0.1 percent Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 7 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation:At least 6 weeks old
- Sex: male
- Weight at study initiation: 1435-1571 grams
- Fasting period before study: none
- Housing:- Diet (e.g. ad libitum): Standard laboratory rabbit diet approx. 100 g. per day.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 3 degrees C
- Humidity (%): 30-70 percent
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour artificial fluorescent light/12 hours dark
IN-LIFE DATES: From: 30 October 2001 To: 02 November 2001

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test substance moistened with 0.5 ml water
VEHICLE
- Amount(s) applied (volume or weight with unit): moistened with 0.5 ml water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after exposure period.

Number of animals:

3 males.

Details on study design:

TEST SITE
- Area of exposure: 150 square centimeters
- Type of wrap if used: Coban elastic bandage
- A 2x3 cm metalline patch mounted on Micropore tape (secured with a coban bandage) were used to apply the test substance to the skin of the animal
- The test substance was moistened with Milli-U water immediately before application to ensure close contact with animal's skin
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed clean with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and eschar formation numerical scoring and edema numerical scoring

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

All animals have scores of zero at all measured time points during the study.

Any other information on results incl. tables

No evidence of a corrosive effects, coloration, systemic toxicity or mortality were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article does not have to be classified and has no obligatory labeling requirements for skin irritation based on EC criteria.

Executive summary:

A primary skin irritation/corrosion study was performed with the test article according to OECD Study Guideline no. 404 (2002). Three New Zealand White albino male rabbits were exposed to 0.5 grams (slightly moistened) of the test article by application onto clipped skin using a semi-occlusive dressing. The exposure period lasted for 4 hours, and then skin reactions were assessed at 1, 24,48 and 72 hours after exposure. Irritation scores of zero were given to all animals (no erythema or oedema were formed). No evidence of a corrosive effects, coloration, systemic toxicity or mortality were observed at any time during the observation period. Therefore, the test article does not have to be classified and has no obligatory labeling requirements for skin irritation based on the EC criteria.