Tetrasodium [2-({4-fluoro-6-[(2-{[4-fluoro-6-({5-(hydroxykappaO)-6-[(2-{[2-(hydroxy-kappaO)-5-sulfophenyl] diazenyl-kappaN1}-4,5-dimethoxyphenyl) diazenyl-kappaN2]-7-sulfo-2-naphthyl} amino)-1,3,5-triazin-2-yl] amino} propyl) amino]-1,3,5-triazin-2-yl} amino) benzene-1,4- disulfonato(6-)] cuprate(4-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 03 May 2006;
Experiment completion date - 12 May 2006;
Study completion date - 12 May 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium [2-({4-fluoro-6-[(2-{[4-fluoro-6-({5-(hydroxykappaO)-6-[(2-{[2-(hydroxy-kappaO)-5-sulfophenyl] diazenyl-kappaN1}-4,5-dimethoxyphenyl) diazenyl-kappaN2]-7-sulfo-2-naphthyl} amino)-1,3,5-triazin-2-yl] amino} propyl) amino]-1,3,5-triazin-2-yl} amino) benzene-1,4- disulfonato(6-)] cuprate(4-)

Cas Number:

882878-51-5

Molecular formula:

C39H28CuF2N14Na4016S4

IUPAC Name:

Tetrasodium [2-({4-fluoro-6-[(2-{[4-fluoro-6-({5-(hydroxykappaO)-6-[(2-{[2-(hydroxy-kappaO)-5-sulfophenyl] diazenyl-kappaN1}-4,5-dimethoxyphenyl) diazenyl-kappaN2]-7-sulfo-2-naphthyl} amino)-1,3,5-triazin-2-yl] amino} propyl) amino]-1,3,5-triazin-2-yl} amino) benzene-1,4- disulfonato(6-)] cuprate(4-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Batch no.: CHU 297 / BOP 04/05
Aggregate state/physical form at room temperature: Solid (powder)
Color: Black
Storage conditions: At room temperature at about 20 °C

Specific details on test material used for the study:

Identity: FAT 40825/A
Batch number: CHU 297 / BOP 04/05
Purity: Organic part (Na-salt): approx. 83.7 %; All coloured components: approx. 80.54 %; Main component: approx. 59.1 %.
Appearance: Solid, black powder
Storage conditions: At room temperature at about 20 °C
Expiration date: December 31, 2010

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test system: Young Adult New Zealand White Rabbit, SPF
Number of animals per test: 3 (Animals of both sexes were used)
Age at treatment: 13 - 14 weeks (male) 13 - 14 weeks (females)
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

HUSBANDRY:
Standard Laboratory Conditions: Air-conditioned with ranges for room temperature 17 - 23 °C, relative humidity 30 - 70 % and approximately 10 - 15 air changes per hour. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.

Accommodation:
Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 (batch no. 77/05) were provided for gnawing.

Diet:
Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 85/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Water: Community tap water from Füllinsdorf, ad libitum.

Water:
Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the dressing

Number of animals:

3

Details on study design:

The primary skin irritation potential of FAT 40825/A was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
NECROPSY: The animals were not sacrificed. No signs of irritation were observed on the treated skin following the application of the test item. For ethical reasons and in the interest of animal
welfare, the animals were therefore re-used for the eye irritation study (RCC Study A53818) using the same test item.

Grading of Skin Reactions:
ERYTHEMA AND ESCHAR FORMATION
No erythema...................... 0
Very slight erythema............. 1
Well-defined erythema...................... 2
Moderate to severe erythema.................... 3
Severe erythema (beef redness) or eschar formation (injuries in depth preventing erythema) reading..... 4

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

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

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or edema was observed at any time point. All the scores at all time points was zero. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. No staining produced by the test item of the treated skin was observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is considered to be "not irritating" to rabbit skin and shall not be classified according to the CLP regulation (Regulation EC No. 1272/2008).

Executive summary:

The primary skin irritation potential of FAT 40825/A was investigated according to OECD test guideline no. 404 in a GLP-certified laboratory. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/ eschar and oedema for each of the three animals was therefore 0. No erythema or edema was observed at any time point. All the scores at all time points was zero. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. And the test item is considered to be "not irritating" to rabbit skin and shall not be classified according to the CLP Regulation (Regulation EC No. 1272/2008).