2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25 MAY 2011 to 16 Jun 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 405) and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid

EC Number:

250-830-4

EC Name:

2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid

Cas Number:

31837-42-0

Molecular formula:

C18H15N5O5

IUPAC Name:

2-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)benzoic acid

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Robinson Services, Inc
- Age at study initiation: young adult
- Housing: single in suspended stainless steel cages
- Diet: Harlan Teklad Global High Fiber Rabbit Diet 2031
- Water: Filtered tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 63-83%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (0.05 g)

Duration of treatment / exposure:

72 h (single application, the treated eyes were not rinsed after application)

Observation period (in vivo):

72 h with observation time points at 1, 24, 48 and 72 h.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: high-intensity white light (Mag Lite), fluorescein (at 24 and/or 48 h reading)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #3 each

Time point:

other: mean of 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not relevant since no effect

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Irritant / corrosive response data:

Individual Animal data (time points: 1h / 24h / 48h / 72h after application, animal #1, animal#2 animal #3)

cornea: 0/0/0/0, 0/1/0/0, 0/0/0/0
iris: 0/0/0/0, 0/0/0/0, 0/0/0/0
conjunctivae redness: 2/1/0/0, 2/2/0/0, 2/2/1/0
chemosis: 1/0/0/0, 1/0/0/0, 1/0/0/0

Other effects:

no signs of gross toxicity or behavioral changes.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test item did not reveal any remarkable irritation potential on the eyes of rabbits, tested in this study according to OECD test guideline no. 405 and GLP conditions.

Executive summary:

The test material was subject to an acute eye irritation / corrosion test in the rabbit according to OECD TG 405. The test item was applied by instillation of 0.1 ml (0.05 g) into the conjunctival sac of the right eye of each of three New Zealand White rabbits. The scoring of irritating effects was performed 1, 24, 48 and 72 hours after test item instillation. No iridial effects were noted during the study. Very slight corneal opacity (score 1) was observed in one animal 24 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness (score 1 or 2) was observed in every animal one and 24 h after application, and in one animals still at the 48 h reading, but fully reversible by 72 h after application. Chemosis (score 1) was observed in every animal one hour after application but not at later time points.