REAKTIV-ORANGE DYPR 1410

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 November 1998 to 27 November 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

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

Reference substance name:

-

EC Number:

432-080-1

EC Name:

-

Molecular formula:

Hill formula: C18H15N3Na2O9S3 CAS formula: C18H17N3Na2O9S3.2Na

IUPAC Name:

Disodium 4-amino-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

microgranulate or well dedusted powder

Details on test material:

Name: Reaktiv-Orange DYPR 1410

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH 88353
Number of animals: 3
Body weight at start of the study: 3.2 - 3.5 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20±3°C
Relative humidity: 50±20%
Lighting time: 12 hours daily
Acclimatization: 1 week under study conditions
Food: ssniff®1 K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

deionised

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg per patch

Duration of treatment / exposure:

4 hours

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-Orange DYPR 1410 pasted with 0.3 ml deionized water. The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specialty produced by Beiersdorl Aktiengesellschaft). 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 as well as 24, 48 and 72 hours after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE . All other changes of the skin were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

30 - 60 minutes up to 48 hours after decontamination the animals showed very slight erythema up to well-defined erythema and sporadically very slight oedema.
72 hours after decontamination all signs of irritation were reversed.

Other effects:

During the whole observation period the skin of the animals were discoloured orange.

Any other information on results incl. tables

Generalised Results by Animal –Animals Against Parameters – Multiple Times

Activity – Skin Irritation Results

Study: 98.0701 – Reaktiv-Orange DYPR 1410 – Skin Irritation Test in Rabbits

Group Sex	Animal Number	Day Number	Time Slot	Bodyweight g	Treated Flank	Duration Treatment	Erythema	Edema
1f	70	1	Treatment	3450	Left	4 hours
			30-60 min. After decontamination				1	0
		2	24 hours after decontamination				1	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0
	71	1	Treatment	32060	Left	4 hours
			30-60 min. After decontamination				1	0
		2	24 hours after decontamination				2	1
		3	48 hours after decontamination				1	0
		4	72 hours after decontamination				0	0
	72	1	Treatment	3290	Left	4 hours
			30-60 min. After decontamination				1	0
		2	24 hours after decontamination				1	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study Reaktiv-Orange DYPR 1410 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 administration and serves as a basis for classification and labelling. The present study was conducted in compliance with EEC-Guideline B.4."Acute Toxicity Skin Irritation" of the Directive 92/69/EEC and OECD Guidelines for Testing of Chemicals, 404 "Acute Dermal Irritation / Corrosion”. This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).

Testing of Reaktiv-Orange DYPR 1410 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.