Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted July 17, 1992 (reported Paris April 29, 1993).

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

July 31, 1992.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

EC Number:

419-210-2

EC Name:

Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

Cas Number:

178452-71-6

Molecular formula:

C66H48CrN16Na5O28S6

IUPAC Name:

chromium(3+) pentasodium bis(7-{4-[2-(1-butyl-5-cyano-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzenesulfonamido}-2-[2-(5-nitro-2-oxido-3-sulfonatophenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

CRL : KBL

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
-Age at study initiation:
male: 16 weeks
females: 16 weeks
-Weight at study initiation:
male: 2.7 kg
females: 2.6 - 2.7 kg
-Housing: individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
-Diet: pelleted standard Kliba 341, Batch 87/94 rabbit maintenance diet ("Kliba". Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
-Water: community tap water from Itingen, ad libitum.
-Acclimation period: four days

ENVIRONMENTAL CONDITIONS
-Temperature: 20 ± 3 °C
-Humidity: 40 - 70 %
-Air changes: 10-15 air changes per hour
-Photoperiod: 12 hours artificial fluorescent light (approx. 100 Lux) /12 hours dark.
-Other: music during the light period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

the test item was moistened with bi-distilled water before application

Amount / concentration applied:

TEST MATERIAL
-Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2 (3.0 cm * 3.0 cm patch of surgical gauze)
- Type of wrap: the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test substance was applied in such a position as to preclude oral ingestion after removal of the dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water to clean the application site so that the reactions (erythema) were clearly visible at that time.

OBSERVATION TIME POINTS
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. Moreover, viability/Mortality and Clinical Signs were observed daily during the observation period.Also body weights were observed at the start of accllmatization, on day 1 of test (application day) and at termination of observation.

SCORING SYSTEM:
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
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

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

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2,#3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

CORROSION
No irreversible alteration of the treated skin was observed nor were corrosive effects evident on the skin.

Other effects:

COLORATION
In the area of application, green staining of the treated skin by coloring of the test substance was observed.

CLINICAL SIGNS AND VIABILITY / MORTALITY
No systemic symptoms were observed in the animals during the test and observation period, and no mortality occurred.

BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The substance is considered to be not irritating for rabbit skin.

Executive summary:

The skin irritation test was performed to rabbit skin according to the OECD Guidelines 404 (1992) and the method B.4 of EEC-Directive 92/69 EEC. 0.5 g of the test item was topically applied onto 6 cm^2 intact dorsal skin of each of 3 young adult New Zealand rabbits. The duration of treatment was 4 hours and the scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test substance was found to be not irritant when applied to intact rabbit skin: local signs (mean values 24/48/72 hours) consisted of grade 0 erythema and grade 0 oedema in all animals. The test item caused green staining (after 1 and 24 hours) and pale green staining (after 48 and 72 hours) of the treated skin area in all animals. No corrosive effect occurred on the treated skin of any animal at any measuring interval.