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Diss Factsheets

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:
21 October, 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 guideline
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).
Deviations:
no
Principles of method if other than guideline:
As per the guideline
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
274-397-6
EC Name:
Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
70209-99-3
Molecular formula:
C23H16BrN3O9S2.2Na
IUPAC Name:
disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
FAT 40068/A
Specific details on test material used for the study:
- Identified as: FAT 40068/A

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: kept separately in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

IN-LIFE DATES: 1974

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol (PEG 400)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
FAT 40068/A was applied to each side in quantities of 0.5 g.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

OBSERVATION TIME POINTS: The reaction of the skin was appraised upon removal and 72 hours after it.

SCORING SYSTEM:
Evaluation of Skin Reactions

Erythema and Eschar Formation
No erythema................................................................................................... 0
Very slight erythema (barely perceptible).................................................. .........1
Well defined erythema..................................................................................... 2
Moderate to severe erythema................................................................... ........3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)........ 4

Edema Formation
No edema...................................................................................................... 0
Very slight edema (barely perceptible).............................................................. 1
Slight edema (edges of area well defined by definite raising................................. 2
Moderate edema (raised approximately 1 mm).................................................. 3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
6
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal: 1, 2, 3, 4, 5, 6
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Time point:
48 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
In scarified skin, all erythema scores at 24 and 48 hours were zero. Edema score was observed as 1 and 2 for animal #2 and #4 respectively at 24h time point only.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance can be classified as a non-irritant.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance qas per the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on 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. FAT 40068/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No erythema was observed in any animals at any time point. Slight edema was observed in 2/6 animals which was reversible at 72h. The primary irritation index of FAT 40068/A was 0.2. Hence, the test substance can be classified as a non-irritant.