Benzenesulfonic acid, 2-[2-[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]diazenyl]-4-[[4-chloro-6-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-, sodium salt (1:2)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 April 1993 to 09 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study condcuted to EU & OECD test guidance in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

84/449/EEC

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

See below

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemisch Pharmazeutische
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.8 - 3.0 kg
- Housing: in fully air conditioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Alromin 2123 maintenance diet, ad libitum and hay (approx 15g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (±3C)
- Humidity (%): 55 (±20%)
- Photoperiod (hrs dark / hrs light): 12 hours lighting per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

500 mg over 2.5 cm2 patch

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

3

Details on study design:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g Reaktiv-Gelb F-66 923 FW pasted with 0.70 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2,5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiers-dorf AG, Hamburg). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE . All other changes of the skin were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal#1

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal#2

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal#3

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal#2

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal#3

Time point:

other: overall 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The animals showed no irritations throughout the study.

Other effects:

From 30 minutes up to 72 hours after removal of the patches the skin surface of the animals was small, light yellow discoloured by the test compound.

Any other information on results incl. tables

DRAIZE SKIN TEST RESULTS

Animal number	ERYTHEMA					OEDEMA
	Time after decontamination				MEAN SCORE	Time after decontamination				MEAN SCORE
	30-60 MIN	1 DAY	2 DAYS	3 DAYS		30-60 MIN	1 DAY	2 DAYS	3DAYS
90	0	0	0	0	0.0	0	0	0	0	0.0
91	0	0	0	0	0.0	0	0	0	0	0.0
92	0	0	0	0	0.0	0	0	0	0	0.0
	OVERALL MEAN : 0.0					OVERALL MEAN : 0.0

The means have been calculated using the day 1, 2 & 3 values.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study Reaktiv-Gelb F-66 923 FW is not irritating to skin

Executive summary:

Testing for primary dermal irritation provides information on the irritant ef­fect of the test substance on the skin following a single dermal application and serves as a basis for classification and labelling.  

The present study was conducted in compliance with EEC Directive B.4. 'Acute toxicity Skin Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 404 "Acute Dermal Irritation/Corrosion" and in compliance with GLP.

 

The animals showed no irritations throughout the study.

 

From 30 minutes up to72 hours after removal of the patches the skin surface of the animals was small, light yellow discoloured by the test compound.

 

Testing of Reaktiv-Gelb F-66 923FW for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.