reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate;tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-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:

13 January 1998 to 20 January 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to recent EU & OECD test guidance in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

427-650-1

EC Name:

-

IUPAC Name:

reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate and tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaktivgelb FD 08064

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
- Weight at study initiation: 3.1 - 3.8 kg
- Housing: Full air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 hours daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

deionized

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4ml

Duration of treatment / exposure:

Exposure 4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: surgical plaster

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

SCORING SYSTEM: DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar formation all animals : 1.7
animal 66 : 1.3
animal 67 : 2.0
animal 68 : 1.7

Oedema formation all animals : 0.3
animal 66 : 0.3
animal 67 : 0.3
animal 68 : 0.3

Based on the results of this study the substance is slightly irritating to skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated:

Erythema and eschar
formation all animals : 1.7
animal 66 : 1.3
animal 67 : 2.0
animal 68 : 1.7

Oedema
formation all animals : 0.3
animal 66 : 0.3
animal 67 : 0.3
animal 68 : 0.3

Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the EU criteria for classification on the basis of the effects noted.

Executive summary:

Study conducted to EU test guidance 92/69/EEC part B4 and OECD guideline 404 in compliance with GLP.

30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar formation all animals : 1.7

animal 66 : 1.3

animal 67 : 2.0

animal 68 : 1.7

Oedema formation all animals : 0.3

animal 66 : 0.3

animal 67 : 0.3

animal 68 : 0.3

Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the EU criteria for classification on the basis of the effects noted.