3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ESTOFIL BLUE S-RLS; C41B

IUPAC Name:

ESTOFIL BLUE S-RLS; C41B

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG CH 4414 Fuellinsdorf I Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 3.0 kg
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libintum
- Acclimation period: Four days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 40-70
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: PEG 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg / site
- Concentration (if solution): moistened with vehicle

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 100 cm²
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke- warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: OECD TG 404 (1984)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 h

Score:

ca. 0.7

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0.4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Irritant / corrosive response data:

The test material showed a primary irritation score of 0.7 when applied to intact rabbit skin.
Local signs (mean 1 hour to 7 day) consisted of grade 0.4 erythema and grade 0.0 edema. They were reversible within 7 days.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

In the area of application a blue staining of the treated skin by the test article (blue pigment) was observed.
The body weight gains of all rabbits were similar. No acute toxic symptoms were observed in the animals during the test period, and
no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

TREATMENT

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).

On test day 1, 0.5 g of the test article (The test article was moistened with polyethylene glycol )

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as applied to the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours.

Four hours after the application, the dressing was removed and the skin was flushed with 1ukewarm tap water. The skin reaction was assessed according to the OECD Guideline for Testing of Chemicals 404. The skin reaction was assessed at 1, 24, 48 and 72 hours and at 7 days after the removal of the dressing, gauze patch and test article.

IRRITATION / CORROSION

The test material showed a primary irritation score of 0.7 when applied to intact rabbit skin. Local signs (mean;1 hour to 7 day) consisted of grade 0.4 erythema and grade 0.0 edema.

They were reversible until day 7.

No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other Findings:

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

The body weight gain of all rabbits was similar.

In the area of application a blue staining of the treated skin by pigment or coloring of the test article was observed.