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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
No deviations ocurred that impacted the integrity of the study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
EC Number:
614-396-3
Cas Number:
68298-12-4
Molecular formula:
C5H4F9NO2S
IUPAC Name:
1,1,2,2,3,3,4,4,4-nonafluoro-N-methylbutane-1-sulfonamide
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3M Company, Lot 3
- Expiration date of the lot/batch:
06 August, 2002
- Purity test date:
30 January, 2002

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark.
- Stability under storage conditions:
Stable
- Stability under test conditions:
Stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The test article was tested neat.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test article was uniformly ground into a powder using a mortar and pestle prior to weighing and dosing.
- Final preparation of a solid:
Dosed as a powder.

FORM AS APPLIED IN THE TEST: The test article was dosed as a powder.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: 7-9 weeks old
- Weight at study initiation: 1.58-1.62 kg
- Housing: Individually in labelled cages with perforated floors.
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g. per day.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 06 November, 2001, To: 09 November, 2001

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with deionized water.

VEHICLE : Deionized water
- Amount(s) applied (volume or weight with unit): Enough to slightly moisten the solid.

NEGATIVE CONTROL : None

POSITIVE CONTROL : None
Duration of treatment / exposure:
The test article was kept in contact with the skin for 4 hours with a semi-occlusive patch.
Observation period:
Observations were made at 1, 24, 48, and 72 hours.
Number of animals:
3 males.
Details on study design:
TEST SITE
- Area of exposure: Dorsal (10 x 15 cm)
- % coverage: Approximately 10%.
- Type of wrap if used: A 2 x 3 cm metalline patch mounted with micropore tape and secured around the abdomen with a coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was washed with water to clear residual test article.
- Time after start of exposure: 4 hours.

OBSERVATION TIME POINTS
1, 24, 48, and 72 hours

SCORING SYSTEM:
- Method of calculation:

Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness)

Edema Formation
0 - No edema
1 - Very slight edema
2 - Slight edema
3 - Moderate edema (raised approximately 1 mm)
4 - Severe edema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no abnormal clinical signs or changes in body weight. No erythema was observed in any animal throughout the study. Edema (scores: 1) was observed in 2/3 animals at 1 hour postdose and resolved by 24 hours postdose. The PII was 0.0/8.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study (PII = 0.0/8.0), the test article is not a dermal irritant.
Executive summary:

The primary skin irritation potential of T-7601 (off white solid, Lot 3) was evaluated in New Zealand White rabbits. This study was performed in accordance with OECD GLP. The study design was based on OECD 404 (1992) and Commission Directive 92/69/EEC B.4 (1992). The hair was clipped from the dorsal skin of three male rabbits. The test material (0.5 g) was moistened with deionized water and placed under a metalline patch on the back of each animal and secured with micropore tape. The torso was wrapped with a coban bandage in a semi-occlusive manner for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 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. No erythema was observed in any animal throughout the study. Edema (scores: 1) was observed in 2/3 animals at 1-hour post dose and resolved by 24 hours post dose. The PII was 0.0/8.0. Based on the results of the study (PII = 0.0/8.0), the test article is not a dermal irritant.