Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 20 SEP 2007 to 14 Dec 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

2002

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 002

Cas Number:

62037-80-3

Details on test material:

-Purity: 86%

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: 2846 g
- Housing: singly in a stainless steel, wire-mesh cage suspended above a cage board.
- Diet: 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: control was untreated eye of test animal

Amount / concentration applied:

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

Duration of treatment / exposure:

28 hours

Observation period (in vivo):

at dosing, 1, 24 and 28 hours

Number of animals or in vitro replicates:

1

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: unwashed



SCORING SYSTEM: Draize Scale


TOOL USED TO ASSESS SCORE: illumination and magnification, fluorescein stain examinations were conducted on the day after instillation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: 1-28 h

Remarks:

positive indication of irritation. because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 28 hours

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 hour

Score:

0

Max. score:

2

Reversibility:

not fully reversible within: 28 h

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 28 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 28 h

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h

Score:

0

Max. score:

3

Reversibility:

not fully reversible within: 28 h

Remarks on result:

other: Brown and white discoloration of the conjunctiva

Remarks:

1-28 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

3

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance.

Remarks:

1-28h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 28 h

Score:

0

Max. score:

3

Reversibility:

not fully reversible within: 28 h

Remarks on result:

other: Brown and white discoloration of the conjunctiva

Remarks:

1-28h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 28h

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 28 hours

Remarks on result:

other: 1-18 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 28 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 28 h

Remarks on result:

other: 1-28 h

Remarks:

because significant scores were noted 1 hour after instillation of the test material, only one animal was treated. This rabbit was sacrificed for humane reasons 28 hours following instillation of the test material

Results 13

Irritation parameter:

other: Discharge

Basis:

animal #1

Time point:

24 h

Score:

>= 2

Max. score:

3

Reversibility:

not fully reversible within: 28 hours

Results 14

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1

Score:

0

Max. score:

2

Irritant / corrosive response data:

Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations were positive for corneal injury in the treated eye. The rabbit was euthanized the day after treatment for humane reasons.
The ocular scores from the animal with respect to observation time are presented in Table 1.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects
	Rabbit No.	Cornea		Iritis	Conjunctiva			Fluorescein Stain	Other
		Opacity	Area		Redness	Chemosis	Discharge
1 Hour	279	2	4	0	0	2	3	NA	-
24 Hours	279	2	2	1	0	4	2	POS	*
28 Hours	279	2	4	1	0	4	2	POS	*

POS= positive for corneal injury

NA = not applicable

- = No other effects

* = Brown and white discoloration of the conjunctiva

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of this study, the test substance produced ocular effects in a rabbit.
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).

Executive summary:

An aliquot of 0.1 mL of test substance was administered to 1 eye of the animal. The treated and control eye remained unwashed following treatment. The conjunctiva, iris, and cornea of the treated eye were evaluated and scored according to a numerical scale approximately 1, 24, and 28 hours following administration of the test substance. Brown and white discoloration of the conjunctival membrane of the treated rabbit eye was observed at 1, 24, and 28 hours after instillation of the test substance. Corneal opacity (score of 2), iritis (score of 1), conjunctival chemosis (score of 2 or 4), and discharge (score of 2 or 3) were also observed. Fluorescein stain examinations of the treated eye were positive for corneal injury. The rabbit was euthanized the day after treatment for humane reasons. Under the conditions of this study, the test substance produced ocular effects in a rabbit.