Disodium 2,5-dichloro-4-[4-[[5-[[(dodecyloxy)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October from 19th to 26th, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

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

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 218

IUPAC Name:

Acid Yellow 218

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, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.37 kg
- Housing: individually housed in suspended metal cages.
- Diet: free access to food (Rabbit Diet, Preston Farmers Limited, Nerv Leake, Boston, Lincolnshire, U.K. and Spillers Rabbit Diet, Daigety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
- Water: free access to mains drinking water.
- Acclimation period: minimum acclimatisation period of five days.
- Health check: on the day before the test each of a group of rabbits was clipped free of fur from the dorsal/ flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Relative humidity: 47 - 65 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g of test material were moistened with 0.5 ml of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

1 female and 2 males

Details on study design:

TEST SITE
- Area of exposure: test item was introduced under a 2.5 cm × 2.5 cm gauze patch and placed in position on the shorn skin.
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm × 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were examined. An additional observation was made on day 7 to assess the reversibility of the skin reactions.

SCORING SYSTEM
The test sites were examined for evidence of primary irritation and scored according to scale decribed in the Draize J.H. (1959), Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics".

Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar fornation (injuries in depth) 4

Oedema formatíon
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.
Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation.
Very slight oedema was noted at two treated skin sites one hour after patch removal.
All treated skin sites appeared normal at the 7-day observation.
The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.

Any other information on results incl. tables

Individual reactions

Animal	Reaction	1 hrs	24 hrs	48 hrs	72 hrs	7 days	Mean 24/48/72 hrs
28 female	Erythema/Eschar	1 STA	1 STA	1 STA	1 STA	0	1.00
39 male	Erythema/Eschar	1	1	1	0	0	0.67
68 male	Erythema/Eschar	1 STA	1 STA	1 STA	1 STA	0	1.00
28 female	Oedema	1	0	0	0	0	0.00
39 male	Oedema	0	0	0	0	0	0.00
68 male	Oedema	1	0	0	0	0	0.00

STA: faint yellow-coloured staining caused by the material

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritating

Executive summary:

The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method used followed OECD guideline 404.

Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.

Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 7-day observation.

The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.

Conclusion

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.