Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 November 1986 to 28 November 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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

Reference substance name:

Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

EC Number:

402-170-5

EC Name:

Trisodium 7-(4-(4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazine- 2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

Cas Number:

106359-91-5

Molecular formula:

C26H26FN9O13S4.3Na

IUPAC Name:

trisodium 7-{2-[2-(carbamoylamino)-4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}phenyl]diazen-1-yl}naphthalene-1,3,6-trisulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 40'224/C
- Description: powder
- Lot/batch No.: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October 1991
- Stability of test article in vehicle: stable for at least 2 hours

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Op. 1/86; Vers. 10/86
- Expiration date of the lot/batch: October, 1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: stable for at least 2 hours

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 / Switzerland
- Age at study initiation: 13 - 14 weeks
- Weight at study initiation: 2.3 - 2.4 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen / FRG).
- Diet: Pelleted standard Kliba 341, Batch 21/86 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

The test article was applied moistened with tap water.

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

up to 72 hours

Number of animals:

3 (2 males and 1 female)

Details on study design:

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 was 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. Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: FAT 40224/C showed a primary irritation score (24, 48, 72 hours) of 0.0 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema.
Corrosion: No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

Coloration: In the area of application an orange staining of the treated skin by pigment or coloring of the test article was observed.
Body Weights: The body weight gain of all rabbits was similar.
Toxic symptoms / mortality: No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy: Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40224/C was found to be not irritating or corrosive to rabbit skin.

Executive summary:

In a GLP-compliant skin irritation study, performed according to OECD guideline 404, FAT 40224/C (moistened, 0.5g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observations were made for an additional 72 hours. The test substance showed a primary irritation score (24,48,72 hours) of 0.0 and local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.0 edema. In the area of application, an orange staining of the treated skin by pigment or coloring of the test article was observed. No corrosive effect was evident on the skin. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive to rabbit skin.