N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

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 OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

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-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

EC Number:

247-820-7

EC Name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Cas Number:

26576-46-5

Molecular formula:

C11H11N3O3

IUPAC Name:

3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide

Details on test material:

- Name of test material (as cited in study report): Acetolon TTR

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Hoechst AG, Kastengrund, conventional breed
Number of animals: 3
Identification of animals: numbered earmarks
Weight of animals: 2.8 - 3.5 kg
Age of animals: 3 - 5 months
Caging: air conditioned rooms, single cages
Temperature: 20 +/- 3 °C
Relative humidity: 50 +/- 20 %
Light: 12 hrs daily
Diet: Altromin 2123 for rabbits, Altromin GmbH, Lage/Lippe, ad libitum, as well as hay (ca 15g daily)
Water: deionised, chlorinated water from automatic feeder, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right untreated eye of each animal served as a control

Amount / concentration applied:

Amount of test substance applied: 100 mg Acetolon TTR (undiluted) per rabbit eye

Duration of treatment / exposure:

single dose, 24 hrs after test substance application eyes where rinsed with physiol. saline solution

Observation period (in vivo):

1, 24, 48 and 72 hrs after test substance application

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: mean of animal # 76, 100, 152 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Reversibility:

other: no signs of cornea irritation (all scores 0, no other cornea effects) during the entire observation period

Results 2

Irritation parameter:

iris score

Basis:

other: mean of animal # 76, 100, 152 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Reversibility:

other: Initial, slight effects were fully reversible within 24 h.

Results 3

Irritation parameter:

chemosis score

Basis:

other: mean of animal # 76, 100, 152 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Reversibility:

other: Initial, slight effects were fully reversible within 24 h.

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 76

Time point:

other: mean of 24, 48, 72 hrs

Score:

0.3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: # 100

Time point:

other: mean of 24, 48, 72 hrs

Score:

0.7

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: # 152

Time point:

other: mean of 24, 48, 72 hrs

Score:

0.3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

One hour after application some blood vessels of the conjuctivae of the animals showed clear hyperemia, red discoloration and swelling. The iris showed redness. 24 hours and 48 hours after application hyperemia of the blood vessels was observed only in one animal. One hour after application clear discharge was observed and one animal showed a white mucous discharge after 24 hours.
All signs of irritation were fully reversible within 72 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

not eye-irritating

Executive summary:

Acetolon TTR was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance was applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as control. After 24 h exposure time the eye was rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

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