Chromate(5-), bis[4-(hydroxy-κO)-7-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-3-[2-[2-(hydroxy-κO)- 3-nitro-5-sulfophenyl]diazenyl]-2-naphthalenesulfonato(4-)]-, sodium (1:5)

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:

1993

Report date:

1993

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:

415-070-1

EC Name:

-

Molecular formula:

C52H26CrN10Na5O22S4

IUPAC Name:

chromium(3+) pentasodium bis(6-[2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]-2-[2-(3-nitro-2-oxido-5-sulfonatophenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

(SPF-Quality)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Broekman Institute, Someren, The Netherlands.
-Age at study initiation: Approx. 12 weeks
-Weight at study initiation: 2528 - 2633 grams
-Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
-Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day.
-Water: Free access to tap-water diluted with decalcified water.
-Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21 °C
-Humidity (%): 55 %
-Air changes (per hr): 15 air changes per hour
-Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light with a fluorescent light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
-Amount applied: 0.5 gram

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): The contralateral flank was similarly prepared (but without test substance and vehicle) to act as a procedural control.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
-Area of exposure: 10x15 cm^2
-Type of wrap if used: Scotchpak-non-woven patch (2x3 cm, 3M, St.Paul, U.S.A.) mounted on Micropore tape (3M, St. Paul, U.S.A.).
The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).

REMOVAL OF TEST SUBSTANCE
-Washing (if done): no, removed using a tissue moistened with tap-water
-Time after start of exposure: 4h

OBSERVATION TIME POINTS
Viabllity/Mortality/Toxicity: Twice daily.
Body Weight:  Day of treatment (prior to application).
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

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:

other: all animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: shaved skin

Results 2

Irritation parameter:

edema score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: shaved skin

Irritant / corrosive response data:

No skin irritation was caused by the test substance after a 4 hour dermal application.
There was no evidence of a corrosive effect on the skin.

Other effects:

Blue staining of the treated skin by the test substance was observed in the treated skin-areas of all animals on day 1.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance is not irritating for rabbit skin.

Executive summary:

The skin irritation test was performed to rabbit skin according to the OECD Guidelines 404 (1981) and the method B.4 of EEC-Directive 92/69 EEC. 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. The test substance caused blue staining of the treated skin only on day of the application. No corrosive effects were noted on the treated skin of any animal at any measuring interval.