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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.6 - 3.9 kg
- Housing: in fully air conditioned rooms; separate cages (arranged in a battery)
- Diet: Altromin 2123 maintenance diet - rabbits; ad libitum
- Water: deionised, chlorinated water; ad libitum

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated right eye served in each case as a control

Amount / concentration applied:

100 mg into the conjunctival sac of the left eye

Duration of treatment / exposure:

Duration of exposure: 24 hours
24 hours after application eyes were rinsed with physiological saline at approx. 37 °C.

Observation period (in vivo):

72 hours after application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : physiological saline at 37°C
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae redness: 0 - 3
conjunctivae chemosis: 0 - 4
conjunctivae discharge: 0 - 3

TOOL USED TO ASSESS SCORE: UV lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 82, 94, 192 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signes of irritation (cornea) at any time

Results 2

Irritation parameter:

iris score

Basis:

animal: # 82, 94, 192 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: no signes of irritation (iris) at any time

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: # 82, 192 each

Time point:

other: mean of 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 94

Time point:

other: mean of 24, 48, 72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: # 82, 94 each

Time point:

other: mean of 24, 48, 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: # 192

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: initial slight effects were fully reversible within 24 h

Irritant / corrosive response data:

From one hour up to 24 hours p.a. the conjunctiva of the animals showed slight swellings as well as up to 48 hours p.a. definitely injected blood vessels to deeper crimson coloured reddenings. Additonal a clear, colourless discharge was noted. 48 hours p.a. the eyes of two animals and 72 hours p.a. the eye of the remaining animal were free of irritations.

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 not eye irritating.

Executive summary:

Acetkresidin 34 TTRS was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye from each of three New Zealand White rabbits. The right eye remained untreated and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.

Based on the findings in this test the test substance is not eye irritating.