Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 03 MAY 1976 to 06 MAY 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

Deviations:

no

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

61932-63-6

Test material form:

solid: nanoform, no surface treatment

Details on test material:

Name of test material (as cited in study report): Permanentrot F6RK CM 86745
Analytical purity: 45.1 % (w/w) (comp. 1) Pigment Red 170, 53.6 % (w/w) (comp. 2) Pigment Red 266

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2.0 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped intact and clipped scarified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg

Duration of treatment / exposure:

24 h

Observation period:

48 h after end of exposure

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Remarks on result:

other: clipped intact and clipped scarified

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Remarks on result:

other: clipped intact and clipped scarified

Irritant / corrosive response data:

Erythema score immediately after removal of the test item could not be detected due to pigment overlay, edema score was 0 for all animals.
The exact same results were obtained for scarified skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.

Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. No erythema or edema were seen at any time point (score 0). The test item is not irritating under these test conditions.