2,7-NAPHTHALENEDISULFONIC ACID 5-[[4-CHLORO-6-(ETHYLPHENYLAMINO)-1,3,5-TRIAZIN-2-YL]AMINO]-3-[[5-[(2,3-DIBROMO-1-OXOPROPYL)AMINO]-2-SULFOPHENYL]AZO]-4-HYDROXY-,SODIUM SALT

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40508/A
- Batch No.: Roe TV 1P
- Storage conditions: below 5°C
- Purity: ca. 60%
- Expiration date: December 1997

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach
- Weight at study initiation: 2670-2810g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No.814, Gossau, Switzerland
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

moistened

Controls:

no

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 male rabbits

Details on study design:

An area of at least 36cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16cm2) bearing 0.5g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm2. A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with distilled water. The patches were loosely covered with an aluminum foil (approx. 36cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

2

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

1.67

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

1

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0.66

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Because of the red staining by the test article the evaluation of possible erythema reactions was impeded up to 72 hours after aplication in all animals. Therefore the mean values 24-72 hours for erythema reactios could not be calculated.
- Slight edema reactions were observed within 72 hours after removing the bandages.
- No signs of skin irritation was observed at the termination of the test on day 7.

Other effects:

- In 2 animals a slight loss of weight was observed on day 3 of the test.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

Executive summary:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. The erythema score could not be determined due to the red color of the test substance. However, after 7 days no erythema was observed. A edema score of 2, 1.67, 1, and 0.66 was observed at 1, 24, 48, 72 hours, respectively. Edema was fully reversible after 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.