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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.9 - 3.4 kg
- Housing: in single cages in completely air conditioned rooms.
- Diet: Altromin 2123 Haltungsdiät-Kaninchen, ad libitum and 15 g hay per day
- Water: deionized and chlorinated water from automatic dispensors, 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 was taken for control

Amount / concentration applied:

100 mg of the substance applicate into the conjunctivae sac of the left eye

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after application and before each control of the eye with saline solution

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

TOOL USED TO ASSESS SCORE: hand-slit UV lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 d

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 d

Score:

0.66

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 d

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 d

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 3 days

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 this test the substance has to be rated as slighly irritant to the eyes but not sufficiently to be classifed as eye irritant.

Executive summary:

The substance was tested for eye irritation according to OECD guideline 405. Three albino New Zealand rabbits got 100 mg of the test item in the conjunctivae sac of the left eye; the untreated right eye was taken for control. After 24 hours the substance was removed by wasing the eyes with saline solution. The condition of the eyes were checked after 1, 24, 48 and 72 hours and rated by a scoring system. The conjunctivae showed 1 hour up to 72 hours after application significant hypermia and slight to significant swelling. additionally the iris was redded for 24 hours at one animal and for another one up to 72 hours. Three days after application one animal was free of symptoms and 7 days after application all animals were free of symptoms.