Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 to 28 May 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FDA Federal Register 38, No 187

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

FDA Federal Register 38, No 187, Patch-Test, occusive scarified and intact skin

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Blue 203

IUPAC Name:

Reactive Blue 203

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Reactive Blue 203

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.8 to 2.2 kg
- Housing: single
- Diet (ad libitum): ERKA Z-6000
- Water (ad libitum): tap water
- Acclimation period: NA


IN-LIFE DATES: From: 25. May To: 28. May 1982

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded areas

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

2 x 500 mg moistened with 0.2 mL physiological saline solution (abraded and intact skin)

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.

TEST SITE
- Area of exposure: 2 x 3 cm x 3 cm
- Type of wrap if used: polyethylene film


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours


SCORING SYSTEM:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24+72 hours

Score:

0.3

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: abraded and shaved skin

Results 2

Irritation parameter:

erythema score

Remarks:

shaved skin

Basis:

mean

Remarks:

animals 1 to 6

Time point:

other: 24 to72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Remarks:

shaved skin

Basis:

mean

Remarks:

animals 1 to 6

Time point:

other: 24 to 72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Time after application		24 h						48 h						72 h
Animal number		1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
abraded	erythema	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
	edema	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0
shaved	erythema	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
	edema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
sum		8						1						0
primary irritation index (24+72)		0.33

Classification Index:

0.0 to 0.5 non irritant

0.6 to 3.0 slightly irritant

3.1 to 5.0 moderately irritant

5.1 to 8.0 severely irritant

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating according to Federal Register 38, No 187
no labelling according to EU guideline

Executive summary:

A group of six rabbits was clipped over a wide area on their backs approximately 24 hours prior to application. One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. Two intact skin sites were also selected on the other side of the back.

A 0.5 g portion of the experimental material was applied to two abraded and two intact skin sites on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of the twenty-four hour contact period, the sites wiped but not washed, and the treated areas examined. Readings were also made after 72 hours. The Draize method of scoring was employed. All other lesions observed were recorded. No irritating effects were observed at any reading. The Mean Primary Irritation Score was: 0.3