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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:
1979
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:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate
EC Number:
941-784-2
Molecular formula:
C38H26N2O10S2.2Na
IUPAC Name:
Reaction mass of Disodium 2-{4-[(9,10-dioxo-4-{[4-(4-sulfonatophenoxy)phenyl]amino}-9,10-dihydroanthracen-1-yl)amino]phenoxy}benzenesulfonate and Disodium 4,4'-[(9,10-dioxo-9,10-dihydroanthracene-1,4-diyl)bis(iminobenzene-4,1-diyloxy)]dibenzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): FAT 21030/C
Specific details on test material used for the study:
Identified as: FAT 21030/C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The test was performed on 3 males and 3 females adult rabbits of the New Zealand White breed (IVANOVAS, 7964 Kisslegg/Allgäu, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland) weighing 2 to 3 kgs. They were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22±2 °C, at a relative humidity of 55±10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water.

Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved and abraded
Vehicle:
other: Propylene glycol+saline (70:30)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material were applied to the prepared abraded and intact skin.
- Concentration (if solution): 50 %
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly shaved with the help of a "Schröpfschnapper" Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application.
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.

SCORING SYSTEM:

*Erythema and Eschar Formation
- No erythema: 0
- Slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet red) to slight eschar formation: 4
Total possible erythema score: 4

*Oedema Formation
- No-oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well defined by definite raising): 2
- Moderate oedema (raised approximately 1 mm): 3
- Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure): 4
Total possible edema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 male and 3 female
Time point:
48 h
Score:
0.167
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 male and 3 female
Time point:
48 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 male and 3 female
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 male and 3 females
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 male and 3 females
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: Abraded skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21030/C is not an irritant to skin.
Executive summary:

An experiment was performed to determine the skin irritation potential of FAT 21030/C in New Zealand White rabbits. The test was carried out according to the method given in the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schröpfschnapper" Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reactions were appraised upon removal and during an observation period of 7 days.

At 24/48/72h time points, FAT 21030/C did not cause irritation to intact skin. Slight irritation was observed on abraded skin which was reversible within 72 hours. The primay irritation index was found to be 0.25. Hence, based on the findings of the study, it can be concluded that FAT 21030/C is not an irritant to skin.