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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:
Study completion date - 14 August 1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
EC Number:
264-129-6
EC Name:
Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate
Cas Number:
63405-85-6
Molecular formula:
C20H18N4O5S.Na
IUPAC Name:
sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
Name: FAT 20004/D
Purity: 61 %

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1°C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
Up to 7 d
Number of animals:
six animals (Three males and three females)
Details on study design:
TEST SITE
- 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. 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.

Score for skin irritation in rabbits
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
Total possible erythema score 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:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
animal:
Remarks:
mean of six 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:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Calculation of the primary skin irritation index:


The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.


 













































Time after exposure hmean reaction score of 6 rabbits 
erythemaedema
intact skin abraded skinintact skinabraded skin
240000
720000
subtotal0000
total0        +       0      +        0      +          0    =     0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.
Executive summary:

A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24-hours exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.