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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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.