Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February from 21st to 27th, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Yellow 125

IUPAC Name:

Reactive Yellow 125

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.3 - 2.5 kg
- Acclimation period: 3 days.

Test system

Type of coverage:

not specified

Vehicle:

water

Controls:

yes, concurrent no treatment

Observation period:

72 hours

Number of animals:

1 male and 1 female

Details on study design:

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours.

SCORING SYSTEM
ERYTHEMA AND ESCHAR FORMATION
No enythema 0
Very slight enythema (barely perceptible) 1
Well defined enythema 2
Moderate to severe enythema 3
Sevene erythema (beet redness) to slight eschar formation (injuries in depth) 4

OEDEMA FORMATION
No edema 0
Veny sIight edema (barely perceptible) 1
Slight edema (edges of area weIl defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Sevene edema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Under the conditions of the experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application, a hardly perceptible yeIlow discolouration of the skin was observed, which could be related to effects of the test article.
No corrosion effect has occurred on the skin at each measuring interval.

Any other information on results incl. tables

Animal N.	Reaction	1 hr	24 hrs	48 hrs	72 hrs
29 M	Erythema	0	0	0	0
30 F	Erythema	0	0	0	0
29 M	Oedema	0	0	0	0
30 F	Oedema	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not skin irritating

Executive summary:

The primary skin irritation potential of the substance was investigated according to OECD test guideline no. 404. The test item was moinstened with tap water, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours.

Under the conditions of the experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application, a hardly perceptible yeIlow discolouration of the skin was observed, which could be related to effects of the test article.

No corrosion effect has occurred on the skin at each measuring interval.

Conclusion

Mean values from gradings at 24, 48 and 72 hours were lower than 2.3 in all animals for both erythema/eschar and oedema reactions. Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.