(1-[2-[5-METHYL-3-(TRIFLUOROMETHYL)-1H-PYRAZOL-1-YL]ACETYL]-4-HETEROMONOCYCLECARBOTHIOAMIDE)

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:

2013

Report date:

2013

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: particulate/powder

Details on test material:

Purity: 92.1%

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: 2225, 2383 and 2603 g
- Housing: The animals were 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 by an automatic water dispensing system.
- Acclimation period: 6 or 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 33-61%
- Air changes (per hr): 12 or 13.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye of each rabbit remained untreated and served as a control

Amount / concentration applied:

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

Duration of treatment / exposure:

Single dose

Observation period (in vivo):

1, 24, 48, and 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: High-intensity white light in accordance with Draize, et al. The fluorescein dye evaluation procedure was used in the treated eye at 24 hours to verify the absence of corneal damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0 - 2

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

other: range

Time point:

other: 1 hour to 72 hours

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

other: range

Time point:

other: 1-72 hours

Score:

0 - 2

Max. score:

4

Reversibility:

fully reversible

Remarks:

48 hours

Results 5

Irritation parameter:

other: discharge

Basis:

other: range

Time point:

other: 1-72 hours

Score:

0 - 2

Max. score:

3

Reversibility:

fully reversible

Remarks:

48 hours

Irritant / corrosive response data:

All animals appeared active and healthy and gained body weight during the study. Apart from the eye irritation noted, there were no other clinical signs observed. There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.

Any other information on results incl. tables

Table 1: Individual Scores for Ocular Irritation
	Rabbit No.: 3401 (Female)				Rabbit No.: 3402 (Female)				Rabbit No.: 3403 (Female)
	Hours				Hours				Hours
	1	24	48	72	1	24	48	72	1	24	48	72
I. Cornea
A. Opacity	0	0^1	0	0	0	0^1	0	0	0	0^1	0	0
B. Area	4	4	4	4	4	4	4	4	4	4	4	4
II. Iris
A. Values	1	0	0	0	1	0	0	0	1	0	0	0
III. Conjunctivae
A. Redness	1	0	0	0	1	1	0	0	1	0	0	0
B. Chemosis	0	0	0	0	0	0	0	0	0	0	0	0
C. Discharge	1	0	0	0	1	1	0	0	1	0	0	0
^12% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance caused slight irritation to the eye.

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.05 mg ( 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. Conjunctival redness (score of 1 and 2), chemosis (score of 2 and/or 1) and discharge (score of 2 and/or 1) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.