Sodium bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From November 18 to November 25,1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The complete read across justification is detailed in section 13. Source study has reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

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 4414 Fuellinsdorf / Switzerland
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard kliba 23/341/1, rabbit maintenance diet defined for acceptable contaminant level, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

ca 10 × 10 cm

Vehicle:

other: PEG 400 + physiological saline solution (70:30)

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 1 g of a 50 % diluition of test material in polyethylene glycol (PEG400) + saline (70:30) was applied under a patch of surgical gauze ca. 3 × 3 cm.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours after treatment.

Number of animals:

3 rabbits (1 male and 2 females)

Details on study design:

TEST SITE
- Clipped area: 10 cm × 10 cm
- Type of wrap if used: surgical gauze 3 cm × 3 cm. When the patch was in place it was covered with impermeable material and fastened to the body with adhesive tape

SCORING SYSTEM: Draize J.H 1959
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: no skin reaction observed

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: no skin reaction observed

Any other information on results incl. tables

Test substance showed no irritation, when applied to intact rabbit skin. No destruction or irreversible alterations of the treated skin were observed.

In the area of application a marked to slight orange discolouration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage.

No acute toxicological signs were observed in the animals durin g the test period.

All rabbits were killed at the end of the observation period. Due to the results obtained, no macroscopical organ examination was indicated.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Under the conditions of the experiment the test material was found to cause no irritation when applied to intact rabbit skin.

Executive summary:

Method

The substance was tested for skin irritation according to the OECD guideline 404. The dorsal area of 3 rabbits was clipped and test substance was applied under occlusive patch for 4 hours. Reactions were scored 1 hour, 24, 48 and 72 hours after removal according to the Draize score.

Results

Under test conditions, the substance was found to cause no irritation when applied to intact rabbit skin. In the area of application a marked to slight orange discoloration of the skin was observed in all rabbits within 1 to 72 hours after removal of the bandage. No corrosion effect had occurred on the skin.