N-(2-methoxy-5-methylphenyl)acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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:

N-(2-methoxy-5-methylphenyl)acetamide

EC Number:

230-157-2

EC Name:

N-(2-methoxy-5-methylphenyl)acetamide

Cas Number:

6962-44-3

Molecular formula:

C10H13NO2

IUPAC Name:

N-(2-methoxy-5-methylphenyl)acetamide

Details on test material:

- Name of test material (as cited in study report): Acetkresidin 34 TTRS, (N-(2-methoxy-5-methylphenyl)acetamide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.8 - 3.2 kg
- Housing: in fully air conditioned rooms, separate cages (arranged in a battery)
- Diet: Altromin 2123 maintanance diet - rabbits, ad libitum
- Water: deionised, chlorinated wated, ad libitum

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol 400

Controls:

no

Amount / concentration applied:

0.5 g test item mixed with 0.30 ml polyethyleneglycol 400

Duration of treatment / exposure:

Exposure period: 4 hours
After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Observation period:

72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cellulose patch fixed by a semi-occlusive bandage

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

SCORING SYSTEM:
erythema: 0 - 4
oedema: 0 - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 84, 99, 100 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (erythema) at any time

Results 2

Irritation parameter:

edema score

Basis:

animal: # 84, 99, 100 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test the test substance is neither skin irritating nor skin corrosive.

Executive summary:

Acetkresidin 34 TTRS was tested for skin irritating properties according to OECD 404. Following this protocol 500 mg test substance mixed with 0.3 ml polyethyleneglycol 400 were applied to the shavede skin of three New Zealands White rabbits. After 4 h exposure time the semi-occlusive patch was removed. Residual substance was removed with warm tap water. Animals were examined for signs of skin irritation/corrosion at 30 - 60 min, 24, 48, and 72 houres after removal of the patches. Mean scores (mean of 24, 48, 72 h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosive.