Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
An adequate in vivo study was conducted on the test article prior to the requirement for in vitro data.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 November 2001-28 January 2002
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:
2001
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report:T-7600
- Substance type: white powder
- Physical state: solid
- Composition of test material, percentage of components: > 97% 2-Propenoic acid, 2-[Methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester, <2% water, <0.01% Phenothiazine
- Lot/batch no.: Lot 1
- Expiration date of the lot/batch: 06 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 and environmental conditions:
TEST ANIMALS
- Sex : Male
- Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: at least 6 weeks old
- Weight at study initiation:between 1.0 and 3.5 kg
- Fasting period before study:
- Housing:- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C
- Humidity (%):30-70%, with temporary deviations due to room cleaning (does not affect study integrity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial light/12 hours dark
IN-LIFE DATES: From: 13 November 2001 To: 16 November 2001

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams of the test substance moistened with 0.5 ml of 50% ethanol in water.
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3/sex/dose
Details on study design:
TEST SITE
- Area of exposure: approx. 150 square centimeters
- % coverage:
- Type of wrap if used: the metalline patch was mounted on micropore tape and wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned using water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and eschar formation (scale 0-4; 4 being severe erythema) and Edema formation (scale 0-4; 4 being severe edema)

Results and discussion

In vivo

Results
Irritation parameter:
other: edema and erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Irritant / corrosive response data:
No irritation or corrosion of the skin was observed during this study.

Any other information on results incl. tables

No mortality or systemic toxicity symptoms were observed during this study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study and according to the EC criteria for classification and labelling requirements, the test substance does not have to be classified and has no obligatory labeling requirement for skin irritation.
Executive summary:

The primary skin irritation/corrosion potential of T-7600 was assessed in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines described in EC Commission Directive 92/69/EEC, B.4 and OECD No. 404. Three male rabbits were exposed to 0.5 grams of the test article, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No mortality, systemic toxicity, corrosive effects or skin irritation was caused by 4 hours exposure to the test article.

Based on the results of this study and according to the EC criteria for classification and labelling requirements, the test substance does not have to be classified and has no obligatory labeling requirement for skin irritation.