Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
A historical in vivo ocular irritation study was conducted on the test substance in the year 2000, prior to in vitro test methods being required.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
A historical in vivo ocular irritation study was conducted on the test substance in the year 2000, prior to in vitro test methods being required.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
EC Number:
216-703-2
EC Name:
1,1,1,2,3,3-hexafluoro-2-(heptafluoropropoxy)-3-[(trifluorovinyl)oxy]propane
Cas Number:
1644-11-7
Molecular formula:
C8F16O2
IUPAC Name:
1,1,1,2,2,3,3-heptafluoro-3-({1,1,1,2,3,3-hexafluoro-3-[(1,2,2-trifluoroethenyl)oxy]propan-2-yl}oxy)propane
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch: 19B 2059
- Expiration date of the lot/batch: 14 January, 2001
- Purity test date: 14 January, 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Darkness at approximately 20C in a fume cupboard under inter (N2) conditions.
- Stability under test conditions: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: No data
- Weight at study initiation: 2.7-3.7 kg
- Housing: Individually
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 C
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 March, 2000 To: 24 March, 2000

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

VEHICLE: None
Duration of treatment / exposure:
Eyes were washed with isotonic saline 24 hours after instillation of the test article.
Observation period (in vivo):
The eyes were examined 1, 24, 48, and 72 hours after administration of the test article.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after instillation with isotonic saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: DRAIZE: Cornea opacity: 0-4, Iritis: 0-2, Conjunctivae redness: 0-3, chemosis: 0-4, discharge: 0-3

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
One hour after administration the conjunctivae of one animal had definitively injected blood vessels. 24 hours after administration, all signs of irritation had resolved.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
On hour after administration of the test article, the conjunctivae of one animal had definitively injected blood vessels. 24 hours after administration, all signs of irritation had resolved. No other signs of irritation were observed in any other animals at any other time points.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the test article is not an ocular irritant.
Executive summary:

The primary eye irritation/corrosion potential of the test article was evaluated in New Zealand White Rabbits. This study was performed in accordance with OECD GLP (1999). The study design was based on OECD 405 (1987) and Directive 92/69/EEC guideline B.5 (1992). Approximately 24 hours prior to the study the eyes of all animals were examined using a fluorescein solution. Animals without ocular abnormalities were selected for this study. The test material (0.1 mL) was administered as received to the conjunctival sac of the left eye of three rabbits. The contralateral eye served as the control. The treated eyes were washed with 37 C saline at 24 hours post-dose. The eyes were examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours post-dose using the Draize technique. Sodium fluorescein dye procedures were used at 24 and 72 hours after dosing to improve the evaluation of the cornea. One hour after dosing, the conjunctivae of one animal showed definitely injected blood vessels (score: 1). At 24 hours after dosing, all animals were normal. Based on the results of this study, the test article is not an ocular irritant.