Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Februaryfrom 1st to 4th, 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guidelines and performed according to 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)

Version / remarks:

adopted 24 April 2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-490-1

EC Name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-60-1

Molecular formula:

C36H21CrN8O11S.2Na

IUPAC Name:

disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)-

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact skin

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 rabbits

Details on study design:

Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

SCORING SYSTEM
Primary Irritation Index:
0: non-irritant
> 0 < 2: Mild irritant
> 2 < 5: Moderate irritant
> 5 < 8: Severe irritant

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

other: mean 24, 48 and 72 hrs

Score:

< 2.3

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

other: mean 24, 48 and 72 hrs

Score:

< 2.3

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

Primary irritation index: 0.0
No evidence of skin irritation was noted.

Any other information on results incl. tables

Individual Skin Reactions Following 4-Hour Exposure Period

Skin Reaction	Observation time	Individual Scores - Rabbit Number and Sex			Total
		35 Male	40 Male	41 Male
Erythema/Eschar formation	1-h	0 STA	0 STA	0 STA	0
	24-h	0 STA	0 STA	0 STA	0
	48-h	0 STA	0 STA	0 STA	0
	72-h	0 STA	0 STA	0 STA	0
Oedema formation	1-h	0	0	0	0
	24-h	0	0	0	0
	48-h	0	0	0	0
	72-h	0	0	0	0
Sum of 24 and 72 Hour Readings (S)					0
Primary Irritation Index (S/6) and Classification*					0/6 = 0.0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

Not irritating

Executive summary:

Method

The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC) .

A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Results and conclusion

Primary Irritation Index: 0.0

The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.