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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(no untreated skin areas to serve as the control; exposure period is of 24 h; smaller area of application (i.e., approx. 2.5 cm2 gauze pad). As test was performed on scarified skin it is considered as deviation.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
EC Number:
941-792-6
Cas Number:
not given
Molecular formula:
C46H32Cl2CoN8O14S2.3Na
IUPAC Name:
Reaction mass of Trisodium bis[2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-) and Trisodium [2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN1)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)][2-({[3-({1-[(2-chlorophenyl)amino]-3-(hydroxy-kO)-1-oxobut-2-en-2-yl}diazenyl-kN2)-4-(hydroxy-kO)phenyl]sulfonyl}amino)benzoato(3-)]cobaltate(3-)
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): FAT 20049/A
- Substance type: Dye
Specific details on test material used for the study:
Test Item: FAT 20049/A
Purity: approx. 89 %

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 1.5 to 2 kg
- Housing: The animals were housed individually in V2A wire cages.
- Diet: Standard rabbit food - NAFAG, Gossau SG, rabbit food (ad libitum)
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and scarified
Vehicle:
other: other: polyethylene glycol (PEG 400)
Controls:
not specified
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): Before application a 50 % Polyethylene glycol trituration (PEG 400) was made.
Duration of treatment / exposure:
24 h

Observation period:
72 h
Number of animals:
6 (3 males and 3 females)
Details on study design:
PROCEDURE:
- 2 days prior to the dermal application, six rabbits were shaved on the whole back and flanks with an electric clipper. The shaven skin of the left side was slightly scarified immediately before treatment.
- A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
- Test substance was applied to each side in quantities of 500 mg. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.

SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)

- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritant / corrosive response data:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.3
Other effects:
none

Any other information on results incl. tables

Evaluation of the skin reactions:

 

Animal No. (sex)

Skin Reaction

24 h after application

72 h after application

Intact

skin

Scarified

skin

Intact

skin

Scarified

skin

1 (M)

Erythema

0

0

0

0

Edema

0

0

0

0

2 (M)

Erythema

0

0

0

0

Edema

0

2

0

0

3 (M)

Erythema

0

0

0

0

Edema

0

2

0

0

4 (F)

Erythema

0

0

0

0

Edema

0

1

0

0

5 (F)

Erythema

0

0

0

0

Edema

0

1

0

0

6 (F)

Erythema

0

0

0

0

Edema

0

2

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the intact skin.
Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance in Russian rabbits according to the method given in the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) which is similar to OECD Guideline 404 with few deviations.

In this study, 500 mg of test substance (i.e. 50 % polyethylene glycol trituration (PEG 400)) was applied to each side. A gauze patch of 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the scarified as well as intact skin of rabbits for 24 h under occlusive conditions. After the 24 h of application period, the dressing was removed and the intact and abraded sites were assessed for oedema and erythema. A further assessment was made at 72 h.

No skin reaction was observed the exposed intact skin. Even no erytehma was seen on the scarified skin as well. However, very slight to slight edema was observed on the sacrificed skin of 5 out of 6 animals, which was fully reversible within 72 h. However, exposure to scarified skin is an elevated testing condition, which leads to increased irritation and is a deviation from guideline. Hence the results obtained with scarified skin normally do not have to be taken into account for hazard assessment. Hence, it was concluded that, under the study conditions, the test substance was not irritating to the intact skin.