1-[5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]ethanone

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF 12-Nouan-8147 (2000)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Details on test material:

- Purity: 99.9%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2475, 2511 and 2483 g
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet: Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water: Filtered tap water was supplied ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 59-69%
- Air changes (per hr): 12 to 13/hour
- Photoperiod: 12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.06 g (0.1 mL)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein, ultraviolet light source

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

other: range

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

other: range

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no cornea effects

Results 3

Irritation parameter:

iris score

Basis:

other: range

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: no iris effects

Results 4

Irritation parameter:

chemosis score

Basis:

other: range

Time point:

24/48/72 h

Score:

0 - 2

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

other: discharge

Basis:

other: range

Time point:

other: 1 hour

Score:

1 - 2

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and/or 2), chemosis (score of 1 and/or 2) and discharge (score of 1 and/or 2) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 72 hours.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects
	Rabbit No.	Cornea		Iritis	Conjunctiva			Fluorescein Stain
		Opacity	Area		Redness	Chemosis	Discharge
1 Hour	3401	0	4	0	1	1	1	NA
	3402	0	4	0	1	2	2	NA
	3403	0	4	0	1	1	2	NA
24 Hours	3401	0	4	0	0	0	0	Checked
	3402	0	4	0	2	1	0	Checked
	3403	0	4	0	1	0	0	Checked
48 Hours	3401	0	4	0	0	0	0	NA
	3402	0	4	0	1	1	0	NA
	3403	0	4	0	0	0	0	NA
72 Hours	3401	0	4	0	0	0	0	NA
	3402	0	4	0	0	0	0	NA
	3403	0	4	0	0	0	0	NA

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Slightly irritating

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and/or 2), chemosis (score of 1 and/or 2) and discharge (score of 1 and/or 2) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 72 hours.