Tetrasodium tripotassium (.my.-((2,2'-((3-imino-6-sulfonatophenyl-(N-methyl)-imino)bis((6-chloro-1,3,5-triazin-4,2-diyl)imino(2-hydroxy-5-sulfonato-3,1-phenylen)azo(phenylmethylen)azo))bis(4-sulfonatobenzoato))-dicuprate(7-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

406-077-0

EC Name:

-

Molecular formula:

Hill formula: C53H29Cl2Cu2K3N18Na4O21S5

IUPAC Name:

dicopper(2+) tripotassium tetrasodium 2-{[({2-[3-({4-[(3-{[4-({3-[({[2-(2-carboxylato-5-sulfonatophenyl)diazen-1-yl](phenyl)methylidene}amino)azanidyl]-2-oxido-5-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl](methyl)amino}-4-sulfonatophenyl)amino]-6-chloro-1,3,5-triazin-2-yl}amino)-2-oxido-5-sulfonatophenyl]hydrazin-2-id-1-ylidene}(phenyl)methyl)imino]amino}-4-sulfonatobenzoate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: males: 2.4 and 2.61 kg; female: 2.45 kg
- Housing: single
- Diet: Kliba 341, 4 mm; Klingentalmühle AG, Switzerland; ca. 130 g/animal/day
- Water: ca. 250 mL tap water/animal/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12. Feb. 1990 To: 14. Feb 1990

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with water to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h; Readings: 30 to 60 min after removal of the patch and 24 h, 48 h, and 72 h after the beginning of applikation
Check for mortality: every work day and once on Saturdays, Sundays and public holidays.

Number of animals:

3 (2 males and 1 female)

Details on study design:

Application
The test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semi occlusive dressing; the test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).

Clipping of the fur: At least 24 hours before the test, the fur was removed by clipping the dorsal part of the trunk of the animals. Only animals with healthy intact skin have been used.
Application site: upper third of the back or flanks.
Negative control: Untreated skin sites of the same animal.
Application volume: The test patch (2.5 cm x 2.5 cm) was covered with dose of 0.5 g of the unchanged solid test substance and has been moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 3

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:

Under the study conditions, the test substance was not irritating to skin.

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance in Vienna White rabbits according to OECD Guideline 404 and EU Method B.4, in compliance with GLP.

0.5 g of the unchanged test substance was applied in a single dose to the intact untreated skin of the 3 New Zealand rabbits for 4 h. The test patch was secured in position with a semi-occlusive dressing and the test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1). The average score (24, 48, and 72 h) for irritation was calculated to be 0.0 in 2 and 0.3 in one rabbit for erythema and 0.0 for edema. The skin findings were reversible within 72 h, thus the study was terminated after 72 h. Under the study conditions, the test substance was not irritating to skin.