Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

Test material

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

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