2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 04 OCT 1983 to 07 OCT 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study (OECD TG 404) GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

EC Number:

236-852-7

EC Name:

2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Cas Number:

13515-40-7

Molecular formula:

C17H15ClN4O5

IUPAC Name:

2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide

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
- strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-house SPF-breeding
- Weight at study initiation: 2.6-2.9 kg
- Housing: individually
- Diet: Altromin 2123 for rabbit husbandry (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1 mL polyethylene glycol 400

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of an adhesive tape in contact with skin site
- Type of wrap: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

None of the animals showed any skin reaction. Erythema and edema scores were 0 at all time points of observation.

Other effects:

Yellow discolouration of treated skin sites.

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 under the test conditions.

Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No erythema or edema were visible (score 0) in any of the 3 animals tested during the observation period (up to 72 hours after end of the 4 h exposure period). The treated skin sites showed a yellow discoloration.