Ammonium difluoro[1,1,2,2-tetrafluoro-2-(pentafluoroethoxy)ethoxy]acetate

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

Kannami Laboratory, Bozo Research Center Inc

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Perfluoro-3,6-dioxaoctanoic acid ammonium salt (EEA-NH4)
- Physical state: white powder
- Analytical purity: 99%
- Lot/batch No.: #070921
- Storage condition of test material: in an air tight container (shielded from light) in a well-ventilated and cold dark place (in a refrigerator: 3 to 8 °C)

Test animals / tissue source

Species:

rabbit

Strain:

other: Japanese white

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Japan laboratory animals Inc
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.38 - 2.52 kg
- Housing: Aluminium cages (Nihon cage co Ltd.) with wire mesh bottoms
- Diet (e.g. ad libitum): RC4 pelleted diet
- Water (e.g. ad libitum): Free access to tap water (Fujimi water Union) via automatic water supply system
- Acclimation period: 12 - 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25°C
- Humidity (%): 39 - 63%
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hour

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

single application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Scale for scoring ocular lesions (Draize's criteria:1959)

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
2% Fluorescein sodium solution

In step 1, 0.1 g of the test substance which was pulverized in a mortar was applied to the left eye of 1 rabbit but no corrosive change was observed in the animal at 1 or 24 hours after application. Therefore, 2 other animals received the test substance in the same manner in step 2.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours

Score:

34

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 1101, 1102, 1103

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 1101, 1102, 1103

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

iris score

Basis:

animal: 1101, 1102, 1103

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 12 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 1101, 1102, 1103

Time point:

other: 24, 48 and 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 16 days

Other effects:

Eyelid closure was observed in all animals immediately after application and in 1/3 animals from 1 hour to day 4 after application. Additionally, corneal vascularization was observed in 1/3 animals on day 6 after application and in all animals from day 7 to day 21 after application.
There were no changes in clinical signs in any animal.