3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic acid] hexasodium salt AND 3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July 2005 to 24 July 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to the guidelines under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)

Cas Number:

75701-36-9

IUPAC Name:

3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)

Test material form:

other: granular solid

Details on test material:

- Name of test material (as cited in study report): Cartasol Blue PE3514 dried
- Physical state: dark blue granular solid (ground to powder for application)
- pH of 10% aqueous solution: 7.5

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually
- Diet: Certified Rabbit Diet (Code 5322) from BCM IPS Ltd, London UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with 0.5 mL of distilled water

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (observations at 1, 24, 48 and 72 hours after removal of the dressing)

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2.5x 2.5 cm2
- Type of wrap if used: cotton gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): swab with cotton wool soaked in distilled 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:

other: 24-72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Other effects:

Blue staining of the application site at all timepoints

Any other information on results incl. tables

Animal	1		2		3
Time	erythema	oedema	erythema	oedema	erythema	oedema
1	0	0	0	0	0	0
24	1	1	1	1	1	1
48	1	1	1	0	1	0
72	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to the skin

Executive summary:

Three rabbits were dermally treated with the substance during 4 hours. Slight irritation of the skin was seen during the 72 hour observation period. The effects were fully reversible at 72 hours. The substance is not irritating to the skin.