Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Kannami Laboratory, Bozo Research Center Inc

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
34
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
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
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
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.

Applicant's summary and conclusion