Trisodium 5-[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-3-methanesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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)

Principles of method if other than guideline:

None

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate

Cas Number:

106359-90-4

IUPAC Name:

Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate

Test material form:

solid: particulate/powder

Details on test material:

None

Specific details on test material used for the study:

None

Test animals

Species:

rabbit

Strain:

other: Chbbibm: NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755 0·7950 Biberach a.d. Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 2.8 kg females: 3.2 kg
- Housing: Individually in stainless steel cages (size: 86 x 54 x 33 em) equipped with feed hoppers and drinking water bottles.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 69/92 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from FOllinsdorf, ad libitum
- Acclimation period: Five days under test conditions after veterinary examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, music during the light period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.5 g of substance was applied.

Duration of treatment / exposure:

4 hours

Observation period:

None

Number of animals:

1 male
2 females

Details on study design:

None

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40000 is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40000, on the skin of the rabbits. 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped 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. Then the dressing was removed and the skin was flushed with lukewarm-tap water. 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 according to the OECD scoring system. The application site was yellow stained up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded. Because no erythema reactions were observed at 24 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test was ended after the 72 hours evaluation. According to the EC classification of the results obtained, FAT 40000/G can be classified as non-irritant in albino rabbits.