Registration Dossier

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: guideline test with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: gas
Details on test material:
A cylinder containing 153g of the test material, Ethene, trifluoro(trifluoromethoxy), Cylinder No. 1199D, was received at IRI on 8 April 1987. The test material, a gas (boiling point -22℃), was stored in the dark under ambient conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two male and one female rabbits(weight range 2.5-3.0kg)were used. They were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays. They were fed on Special Diet Services Rabbit Diet of satisfactory analysis and allowed food and water ad libitum. A 12 h light/dark cycle was in operation. Mean environmental maximum and minimum temperatures were 19℃ and 16℃ and mean relative humidity was 54%. The animals were allowed an acclimatisation period of 63 days before test commencement.

Test system

Vehicle:
not specified
Controls:
other: the other eye remained untreated to serve as a control
Amount / concentration applied:
in a single burst
Duration of treatment / exposure:
1 second
Observation period (in vivo):
at 1, 24, 48 and 72 h after instillation
Number of animals or in vitro replicates:
two males and one female
Details on study design:
The rabbit was held firmly but gently and the right eye was held open. The test material was then administered in a single burst of about 1 s duration from a distance of 10 cm directly in front of the eye. The lids were then gently held together for 1 or 2s. The other eye remained untreated to serve as a control. The eyes were examined for irritation, using standard illumination, at 1,24, 48 and 72h ater instillation, using the scoring system as OECD 405.

Results and discussion

In vivo

Results
Irritation parameter:
other: cornea, iris, conjunctivae: redness, chemosis, discharge
Basis:
other: all animals
Time point:
other: 1, 24, 48 and 72h
Score:
0

Any other information on results incl. tables

See data reported in the field "Attached background material".

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It can be concluded that the test substance is non-irritant to rabbit eyes.
Executive summary:

Two male and one female rabbits were used to conduct this acute eye irritation test. The test material was administered in a single burst of about 1 second duration .The eyes were examined for irritation. The reaction scores for cornea, iris, and conjunctivae in this test are 0. No corneal, iridial or conjunctival responses were noted. Therefore, it can be concluded that the test substance shall not be classified according to CLP(Regulation EC No.1272/2008).