Heptasodium bis[4-hydroxy-5-[(2-hydroxy-1-naphthyl)azo]-3-[(2-hydroxy-3-nitro-5-sulphophenyl)azo]naphthalene-2,7-disulphonato(5-)]cobaltate(7-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1987

Deviations:

not applicable

Remarks:

4-hour application

Principles of method if other than guideline:

The test item were applied to clipped skin of three rabbits for 4 hours and the readings were performed after 30 minutes and 24, 48 and 72 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black 076

IUPAC Name:

Acid Black 076

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
- Gender: male
- Housing: all animals were housed in individual cages
- Diet: a standard laboratory diet were provided ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30 to 70 %
- Air changes: 15 changes/hour
- Photoperiod: the light/dark cycle was 12 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

WEM

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 1 ml
- Preparation: diluted with WEM

Duration of treatment / exposure:

4 hours

Observation period:

30 minutes, 24, 48 and 72 hours

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: back of the animals
- Preparation: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries
- Area of coverage: 6.5 cm²
- Type of wrap if used: surgical gauze
- Other: the animals were immobilised with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve for the 4 hour exposure

SCORING SYSTEM
Erythema and Edema:
0 - No finding
1 - Barely perceptible effect
2 - Slight, well defined effect
3 - Moderate
4 - Severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: intact skin

Results 3

Irritation parameter:

edema score

Basis:

animal: #2 and #3

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: intact skin

Any other information on results incl. tables

Table 1: Results.

Animal no.	Symptom	30 minutes	24 hours	48 hours	72 hours
no. 4 (male)	Erythema intact skin	0	0	0	0
	Oedema intact skin	0	0	0	0
no. 5 (male)	Erythema intact skin	0	0	0	0
	Oedema intact skin	1	1	0	0
no. 6 (male)	Erythema intact skin	0	0	0	0
	Oedema intact skin	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) no. 1272/2008

Conclusions:

The test item was found to be not irritating to rabbit skin in vivo

Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo experimental study equivalent to the OECD Guideline 404 (1987). 1 ml of test item diluted in WEM was applied to the clipped skin of three male, New Zealand White rabbits for 4 hours using an occlusive dressing, and skin was monitored for erythema and oedema at 30 minutes, 24, 48 and 72 hours.

The mean (24/48/72 hours) erythema scores were 0 in all animals; mean (24/48/72 hours) oedema scores were 0 in animal #1, and 0.33 in animals #2 and #3, and oedema was reversible within 48 hours.