5-amino-1,3-dihydro-2H-benzimidazol-2-one

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)

Version / remarks:

updated Guideline, adopted 24th february 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

EC Number:

202-401-8

EC Name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

Cas Number:

95-23-8

Molecular formula:

C7H7N3O

IUPAC Name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

Details on test material:

The test item contains about 38 % water. Reason is that this compound is manufacturer and further processed only as water wet substance.
It is not expected that the additional amount of water has an influence on the results.

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 breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.2-4.0 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, Altromin GmbH, ad libitum and hay 15 g per day
- Water (e.g. ad libitum): deionized, chlorinated water from automatic feeder, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

single application / washing with physiol. saline (37°C) 24 hrs after application of test substance

Observation period (in vivo):

1, 24, 48 and 72 hrs post application

Number of animals or in vitro replicates:

3

Details on study design:

- washing with physiol. saline (37°C) 24 hrs after application of test substance and all following observations where eyes show secretion or coronea was examined

- Tools to assess score: fluorescin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.7

Reversibility:

fully reversible

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.3

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hrs

Score:

1.3

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.3

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.2

Reversibility:

fully reversible

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.7

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 13

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.2

Reversibility:

fully reversible

Results 14

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

Results 15

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0.7

Results 16

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 hrs

Score:

0

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:

The test substance was tested for eye irritating properties according to OECD 405. Following these protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as a control. 24 h after instillation eyes were 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, 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Mean scores for all irritation parameters were below threshold values and were fully reversible within 72h.

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