2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 01 NOV 1988 to 04 NOV 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 404; EU method B4), in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

EC Number:

219-730-8

EC Name:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

Cas Number:

2512-29-0

Molecular formula:

C17H16N4O4

IUPAC Name:

2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, breeding colony, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.4 kg
- Housing: individually
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum and 15 g hay/day
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: polyethylenglycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1.2 ml polyethylenglycol 400.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: as in OECD TG 404 described, reading at 30-60 min, 24, 48 and 72 h after removal of test item.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effects

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effects

Irritant / corrosive response data:

No effects (erythema or edema) were visible at any time point in all animals.

Other effects:

The treated skin was coloured yellow.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to skin when tested under the conditions of the OECD guideline 404.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.The test item (0.5 g pasted with 1.2 ml polyethylenglycol 400) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. No erythema or edema were observed at any time point (score 0). There was no indication of systemic toxicity.