Reaction mass of tetrasodium 5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl) diazenyl]naphthalene-2,7-disulfonate and trisodium 5-({4-chloro-6-[4-(vinylsulfonyl) anilino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October to 3 November 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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:

405-900-0

EC Name:

-

Cas Number:

111211-40-6

Molecular formula:

C29H22ClN7Na4O19S6

IUPAC Name:

tetrasodium 5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino) -1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl) diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv-Rot F-66813 FW

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.1 - 3.1 kg
- Housing: single
- Diet: Altromin 2123 maintenance diet ad libitum and approx. 15 g hay/day
- Water: deionized chlorinated water ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 31. Oct To: 03 Nov. 1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

500 mg pased with 0.4 mL of 0.9% physiological saline solution

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 4 hours

About 24 hours prior dermal treatment the fur of three rabbits was removed from the dorsal part of the torso with an electric hair clipper over an area of approximately 25 cm2. Only animals with intact skin were used.

500 mg of Reaktiv-Rot F-66813 FW (pasted with 0.40 mL 0.9% NaCI-solution) was applied to each animal. The pasted test substance was spread over the whole surface of the 2.5 x 2.5 cm cellulose patch of a surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster strip was then fixed to the prepared skin and covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the end of the 4 hours exposure period remnants of the still remaining test substance were removed from the skin with lukewarm water.

The skin was examined 30 - 60 minutes and 24, 48 and 72 hours after removal of the plaster.

Erythema, eschar formation and edema were evaluated numerically. 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 slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

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

Irritant / corrosive response data:

There were no signs of skin irritations during the whole study period. However, large areas of the treated skin were red discolored during the whole course of the study.

Other effects:

Reddish discoloration at treated skin during entire observation time

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Reaktiv-Rot F-66813 FW is not irritating to the skin and not subject to labelling requirements

Executive summary:

Based on the results of the present rabbit primary dermal irritation study Reaktiv-Rot F-66813 FW is not irritating to the skin and not subject to labelling requirements according to the classification critera of the Directive 83/467/EEC and the Ordinance on Hazardous Substances.