Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20 Nov, 1978 to 28 Nov, 1978

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) , the US Association of Food and Drug Officials (AFDO).

Deviations:

yes

Remarks:

Abrasion represent an elevated testing condition compared to todays standard testing conditions accordint to OECD guidelines.

GLP compliance:

no

Remarks:

Study predates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

EC Number:

278-174-4

EC Name:

Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Cas Number:

75284-35-4

Molecular formula:

C39H20Cu2N5O15S3.3Na

IUPAC Name:

trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch No: EN 80524/76
Physical appearance: Powder

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Metal cages
- Diet: ad libitum standard rabbit food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22±1 °C
- Humidity: 55±5 %
- Light cycle: 10 h light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

other:

Remarks:

50% propylene glycol + saline (70:30 parts)

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

Six rabbits (3 males and 3 females)

Details on study design:

The test was performed on 3 male and 3 female adult rabbits of the Himalayan breed (WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany) weighing 1.5 to 2 kgs. They were housed individually in metal cages, were kept at a constant room temperature of 22 ± 1 °C, at a relative humidity of 55 ± 5 % and on a 10 hours light cycle day.
The animals received ad libitum standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

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 "SchröpfSchnäpper", 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.

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

Total possible edema score ............................................................................................................4

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 11127/B was considered to be a non-irritant to rabbit skin.

Executive summary:

FAT 11127/B was tested for skin irritation potential according to the patch technique described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO)." 0.5 g of test substance was suspended at 50 % concentration in propylene glycol + saline (70 : 30 parts) and applied on the intact as well as abraded skin of 6 Himalayan rabbits (3 males and 3 females) for period of 24 hours. The skin reaction was appraised upon removal and during an observation period of 7 days. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). Following this methodology, it was concluded that no erythema or edema were seen at any of the observations. Hence, FAT 11127/B was considered to be a non-irritant to rabbit skin.