Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 11 to 14, 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

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:

Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium

EC Number:

284-915-2

EC Name:

Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium

Cas Number:

84989-26-4

Molecular formula:

C36H20CrN8Na3O14S2

IUPAC Name:

trisodium 12'-methyl-6',7-dinitro-14'-phenyl-2',13,15,16'-tetraoxa-1λ⁵,2,9',10'λ⁵,13',14'-hexaaza-14-chromaspiro[hexacyclo[12.11.0.0³,¹².0⁴,⁹.0¹⁶,²⁵.0¹⁹,²⁴]pentacosane-14,1'-tetracyclo[8.6.0.0³,⁸.0¹¹,¹⁵]hexadecane]-1,3,3'(8'),4',5,6',7,9,9',11,11'(15'),12',16(25),17,19,21,23-heptadecaene-1,10'-bis(ylium)-14,14,14-triuide-4',10-disulfonate

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 Madoerin AG CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: 2.1 - 2.8 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning, and drinking system.
- Diet: ad libitum; pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet. Food was analysed for contaminants.
- Water: ad libitum; community tap water from Itingen. Water was analysed for contaminants.
- Acclimation period: four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity: 40 - 70 %.
- Air changes: air-conditioned with 10-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music/light period.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The test article (0.5 g) was applied moistened with tap- water.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 male and 1 females

Details on study design:

TEST SITE
- Area of exposure: approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimetres (10 cm x 10 cm).
- Type of wrap if used: on test day 1, the test article was applied to the intact skin of the shaved, area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with aluminium foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: flushed with luk e warm tap water.
- Time after start of exposure: 4 hours after the application.

SCORING SYSTEM
The skin reaction was assessed according, to the QECD Guidelines for Testing of Chemicals, Section 4, number 404, pp. 3-4. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #55, #56, #57

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #55, #56, #57

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item showed a primary irritation score of 0 when applied to intact rabbit skin.
In the area, of application a black discoloration of the skin was observed which could be related to effects of the test article.
No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

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

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

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

Any other information on results incl. tables

Animal/sex	Reaction	1 hr	24 hrs	48 hrs	72 hrs	Mean 24, 48 and 72 hrs
55 M	Erythema	0	0	0	0	0.00
56 M	Erythema	0	0	0	0	0.00
57 F	Erythema	0	0	0	0	0.00
55 M	Oedema	0	0	0	0	0.00
56 M	Oedema	0	0	0	0	0.00
57 F	Oedema	0	0	0	0	0.00

Applicant's summary and conclusion

Interpretation of results:

other: Not classified as skin irritatnt according to the CLP Regulation (EC) No. 1272/2008.

Conclusions:

not irritating

Executive summary:

Method

The skin irritation/corrosion potential of the test item was assessed according to the OECD guideline 404 and EU Method B.4.

Results

Under the test conditions, the substance was found to cause a primary irritation score of 0 when applied to intact rabbit skin.

In the area of application, a black discoloration of the skin was observed which could be related to effects of the test article.

No corrosive effect had occurred on the skin at each measuring interval.

Conclusion

The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.

In conclusion, the test item can be classified as non irritating, according to the CLP Regulation (EC 1272/2008).