Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From July 5 to 8,1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Complete read across justification is attached in section 13. Source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

RA Substance 01

IUPAC Name:

RA Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG
- Weight at study initiation: 3 - 4 kg
- Housing: in individual cages in air-conditioned rooms
- Diet : Breeding diet Altromin 2013 - Rabbit (Altromin GmbH, Lage / Lippe), ad libitum
- Water : deionized water, chlorinated water from automatic watering tables, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hrs cycle dark/light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: pasted with 0.25 mL PEG400

Controls:

not required

Amount / concentration applied:

500 mg pasted with 0.25 mL PEG400 applied to shaved skin of 2.5 cm × 2.5 cm.

Duration of treatment / exposure:

4 hours.

Observation period:

30 min, 24 h , 48 h , 72 h after removal of the patches.

Number of animals:

3 rabbits.

Details on study design:

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

REMOVAL OF TEST SUBSTANCE
- Washing: after the 4 hours exposure period

SCORING SYSTEM: according to Draize
Erythema and eschar formation
0 No erythema
1 Very slight, barely perceptible erythema
2 Well developed erythema
3 Moderate to severe erythema
4 Severe erythema (dark red) to slight eschar formation (injury in the depth of the skin)

Oedema formation
0 No oedema
1 Very light, hardly perceptible oedema
2 Light oedema, boundaries are well marked by a distinct elevation.
3 Medium oedema, lift off about 1 mm
4 Heavy oedema, lifting more than 1 mm and exceeding the limits of the application site

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal: 1, 2, 3

Time point:

24/48/72 h

Score:

0

Any other information on results incl. tables

time post-application	animal	erythema	oedema
1 h	1	0	0
	2	0	0
	3	0	0
24 h	1	1	0
	2	0	0
	3	0	0
48 h	1	0	0
	2	0	0
	3	0	0
72 h	1	0	0
	2	0	0
	3	0	0

Applicant's summary and conclusion

Interpretation of results:

other: non irritant according to the CLP Regulation (EC 1272/2008)

Conclusions:

In the experimental conditions described by OECD guideline 404 for the examination of acute dermal irritation / corrosion potential, test substance resulted as not irritant to the skin.

Executive summary:

Method

Examination of acute dermal irritation/corrosion in 3 rabbits according to OECD guideline 404, by semiocclusive application of test substance on shaved skin for 4 hours.

Results

No signs of irritation were noted except for one animal showing very slight erythema after 24 hours. However, it reversed within 48 hours. Consequently, test substance is considered as non irritant to the skin.