Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride (1:?)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride

EC Number:

618-990-3

Cas Number:

939961-06-5

Molecular formula:

C15H15N3O3xClH

IUPAC Name:

3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.4 - 3.7 kg
- Housing: single cages in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiät-Kaninchenad libitum and about 15 g hay per day
- Water: chlorinated deionized water from automatic dispensors, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+-3
- Humidity (%) :55+-20
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

500 mg test item suspended with 0.4 ml 0.9% NaCl-solution

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: plaster fixed with a semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with slightly warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the result of the test the substance has not to be classified as irritating to the skin.

Executive summary:

The substance was tested for skin irritation according to OECD guideline 404. Three New Zealand albino rabbits were shaved to get an area of approximately 25 cm² of fre skin. 500 mg of the test item was suspended with 0.4 ml 0.9% NaCl-solution and this suspension was fixed on an area of 2.5 cm x 2.5 cm with a plaster on the prepared skin. The plaster was fixed with a semiocclusive bandage. After an exposure time of 4 hours the plaster was removed and the skin was washed with slightly warm tap water.

After 1 hour neither erythema nor edema could be observed on the skin of the rabbits.