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-)

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

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.