A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29. Sep. 1987 to 02. Oct. 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

EC Number:

402-850-1

EC Name:

A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

trichromium(3+) nonasodium 6-[2-(2-amino-4-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(2-amino-6-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(4-amino-2-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate tris(6-{2-[(1Z)-2-hydroxy-1-(phenylcarbamoyl)prop-1-en-1-yl]diazen-1-yl}-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madörin AG, 4414 Füllingsdorf, CH
- Age at study initiation: 14 to 15 weeks
- Weight at study initiation: 2.6 to 2.7 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet: ad libitum; pelleted standard Kliba 341, batch 30/87 rabbit maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hr
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

electric clippers used 24 hours before treatment

Vehicle:

other: moistened with water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g solid

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Males: 2
Females: 1
Total: 3

Details on study design:

TEST SITE
- Shaved area: 100 cm² (10 cm x 10 cm)
- Area of exposure: 9 cm² (3 cm x 3 cm)
- Location: dorsal
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Semi-occlusive dressing
- Test item removed and washed with lukewarm tap water 4 hours after application

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after application

SCORING SYSTEM:
- Colouration, corrosion and toxic symptom observations
- Irritation scores (both erythema score and oedema score):

ERYTHEMA AND ESCHAR FORMATION (Maximum possible score: 4)
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

OEDEMA FORMATION (Maximum possible score: 4)
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

IRRITATION
- Irritation scores for the test item (mean 24, 48 and 72 hours) were 0 for both erythema and oedema.

CORROSION
- No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

COLOURATION
- In the area of application slight black staining of the treated skin by pigment or colouring of the test item was observed after 1 hour in 2 rabbits. No rabbits demonstrated discolouration after 24 hours.

BODY WEIGHTS
- The body weight gain of all rabbits was similar.

TOXIC SYMPTOMS / MORTALITY
- No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

NECROPSY
- Due to the results obtained, no macroscopic organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No.1272/2008

Conclusions:

The test item was not found to be a skin irritant or a skin corrosive.

Executive summary:

Skin irritation potential of the test item was evaluated in an in vivo experimental study performed according to the OECD Guideline 404 (1987) and EU method B.4 (1984). 0.5 g of moistened, solid test item was applied to the shaved, dorsal area of three female rabbits for a duration of 4 hours. Observations of irritation (erythema and oedema scores; maximum score: 4) and corrosion (local destruction or corrosion) were recorded 1, 24, 48 and 72 hours after removal of the bandage. Animals were monitored for local discolouration (daily), toxic symptoms (daily) and body weight (end of study period).

Irritation scores (mean scores of 24, 48 and 72 hours) were 0 for both erythema and oedema for all animals. In the area of application, slight black staining of the treated skin by pigment or colouring of the test item was observed in 2 animals and was reversible within 24 hours. No corrosive effect, toxic symptoms or significant body weight differences were observed.