tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 17, 1999 to August 20, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-550-6

EC Name:

-

Cas Number:

243858-01-7

Molecular formula:

Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na

IUPAC Name:

tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Orange F97-0318

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg.
- Body weight range at treatment: 2.8-3.4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (i.e., approximately 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Numbered ear tags

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: August 17, 1999 to August 20, 1999

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg (i.e., 0.5g)

Duration of treatment / exposure:

4 h

Observation period:

30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches.

Number of animals:

3 females

Details on study design:

TEST PROCEDURE
About 24 h before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g test substance pasted with 0.5 mL deionized water. The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (i.e., specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 h after removal of the patches.

Erythema, eschar formation and edema were evaluated numerically according to the score of Draize . All other changes of the skin were recorded.

SCORING SYSTEM:

Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4
Not assessable.....................................................................................................................*
Edema
No edema..............................................................................................................................0
Very slight edema (barely perceptible).............................................................................1
Slight edema (edges of area well defined by definite raising).......................................2
Moderate edema (raised approximately 1 mm) ..............................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4
Not assessable......................................................................................................................*

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

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

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

30 - 60 min up to 1 d after removal of the plaster the animals showed orange discolored skin.
3 d after administration all discolorations were disappeared.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be non-irritating to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance in femaleNew Zealand albino rabbit according to OECD Guideline 404 and EU Method B.4, in compliance with GLP.

500 mg of test substance pasted with 0.5 mL deionized water was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 25 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 30 - 60 min, and at 24, 48 and 72 h.

Except for orange discolored skin in treated animal up to 1 d after removal of the plaster, no severe signs of irritation were observed during the whole observation period. Further, all discolorations were reversiblewithin 3 d. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.00 for edema formation.

Under the test conditions, the test substance was considered to be non-irritating to skin.