Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11

Version / remarks:

February 1965

GLP compliance:

no

Remarks:

pre GLP

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 017

IUPAC Name:

Acid Yellow 017

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: average body weights of 2.80 males and 2.60 kg females.
- Housing: rabbits were caged singly.
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum.
- Water: sterile filtered water, ad libitum.
- Acclimation period: one week prior to the start of the trial.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Relative humidity: 50-70 %
- Photoperiod: animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact shaved skin and abraded skin

Vehicle:

water

Controls:

yes

Amount / concentration applied:

10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.

Duration of treatment / exposure:

24 hours

Observation period:

6 days

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 24 hours prior to the dermal application, the backs of the rabbits were shaved. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneurn but not to damage the dermis. The left hand site remained intact.
- % coverage: area consisting of at least 10 % of the total body surface.
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6 wide "Coban" self adhesive bandage in order to retain the test substance in close contace with the skin.

SCORING SYSTEM
The assessment of the macroscopic skin reaction was made according to the following grading system:
Primary Irritation Score
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 . 6.5 Severely irritating
6.6 - 8.0 Extremely irritating

Erythema and Eschar Formation - Description
No erythema 0
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4

Oedema Formation - Description
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 mm.) 3.
Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 6/6, both intact and abraded skin

Time point:

other: 24/72 hrs

Score:

< 2.3

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

edema score

Basis:

animal: 6/6, both intact and abraded skin

Time point:

other: 24/72 hrs

Score:

< 2.3

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

The primary irritation score was 1.8.
Slight to well defined erythema and wery slight to moderate oedema were seen on all rabbits 24 hours after application of the compound. By 72 hours there was only one abraded site still showing slight erythema and very slight oedema. This was normal by 6 days.
There was uery little difference in the reactions seen between abraded and intact sites.

Any other information on results incl. tables

Skin irritation reactions

N./sex	Intact skin			Abraded skin
	24 hrs	72 hrs	6 days	24 hrs	72 hrs	6 days
Erythema
11M	1	0	0	2	0	0
13M	1	0	0	2	0	0
15M	1	0	0	1	0	0
12F	1	0	0	2	1	0
14F	1	0	0	2	0	0
16F	2	0	0	2	0	0
Mean	1.17	0.00	0.00	1.83	0.17	0.00
Oedema
11M	2	0	0	2	0	0
13M	2	0	0	2	0	0
15M	1	0	0	2	0	0
12F	2	0	0	3	1	0
14F	3	0	0	2	0	0
16F	1	0	0	1	0	0
Mean	1.83	0.00	0.00	2.00	0.17	0.00

Applicant's summary and conclusion

Conclusions:

Mild irritating

Executive summary:

Method

The skin irritation was determined in an irritation test on rabbits according the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)., similar to OECD guideline 404.

Result

The primary irritation score was 1.8.

Mild irritating