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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 guideline
Qualifier:
according to guideline
Guideline:
other: The procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191 .11), a transcript of which is attached as an Appendix to this report.
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
EC Number:
282-316-0
EC Name:
Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Cas Number:
84145-95-9
Molecular formula:
C32H17CrN6O11S.2Na
IUPAC Name:
disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 20013/D TE
Batch 1502011 (China)
Purity determined in this study
Appearance black powder at 20°C
Smell neutral
pH-Value pH-value of a solution of 2% (w/w) = 9.2
Expiration date August 03rd, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
Name: FAT 20013/A
Purity: 59 %

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: abraded and intact
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g of the solid was mixed to a paste with 0.5 ml of water before application to each treatment site.
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6 animals

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:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20013/A is to be considered as a non-irritant to the skin of rabbits.
Executive summary:

A study was performed to determine the acute irritation potential of FAT 20013/A, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191 .11). Six Albino white rabbits (3 males and 3 females) were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the test substance was mixed with 0.5mL of water to form paste before application to each treatment site. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches were removed, and the resulting reactions were evaluated. No erythema or edema was observed at 24- and 72-hour readings. Based on the findings of this study, FAT 20013 is to be considered as a non-irritant to the skin of rabbits.

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