Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 June 1992 to 12 June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD Guideline-conform study conducted under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981 and subsequest revisions)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

EC Number:

500-537-5

EC Name:

Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Cas Number:

161075-00-9

Molecular formula:

R-O(C3F6O)m-R with R= - CF3, - C2F5, -CF2H

IUPAC Name:

1,1,1,2,3,3-hexafluoro-2,3-bis(1,1,2,2,2-pentafluoroethoxy)propane; 1,1,1,2,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)-3-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)-2-(trifluoromethoxy)propane; 1,1,1,2,3,3-hexafluoro-3-{[1,1,1,2,3,3-hexafluoro-3-(trifluoromethoxy)propan-2-yl]oxy}-2-(trifluoromethoxy)propane; 1,1,1,3,3,4,6,6,7,9,9,10,12,12,12-pentadecafluoro-4,7,10-tris(trifluoromethyl)-2,5,8,11-tetraoxadodecane; 1-(difluoromethoxy)-1,1,2,3,3,3-hexafluoro-2-(1,1,2,2,2-pentafluoroethoxy)propane; 2,2,3,5,5,6-hexafluoro-3,6-bis(trifluoromethyl)-1,4-dioxane; 2-(difluoromethoxy)-1,1,1,2,3,3-hexafluoro-3-(1,1,2,2,2-pentafluoroethoxy)propane

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Galden HT 70
- Substance type: Pure substance
- Physical state: liquid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: G 30
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: far from heating sources (volatile)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: livestock farming
- Age at study initiation: about 2-3 months
- Weight at study initiation: about 2.5 - 3 kg
- Housing: individual caging in air-conditioned rooms. Metal cages measuring 62 x 47.5 x 38 cm.
- Diet (e.g. ad libitum): Certificated pelleted diet, supplied with vitamins and trace elements. Available ad libitum
- Water (e.g. ad libitum): from municipal water main system, filtered and disrtibuted ad libitum.
- Acclimation period: about 3 weeks. Animals were observed daily to ascertain their fitness for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +-2
- Humidity (%): 50 % +- 15
- Air changes (per hr): about 15/ hour
- Photoperiod (hrs dark / hrs light): 12 hour cicle (7 a.m.-7 p.m.)

IN-LIFE DATES: From: To: not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml /animal
- Concentration (if solution): not applicable

VEHICLE
Test material was applied as supplied by the sponsor.

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

at 1, 24, 48 and 72 hours after the test article application.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with sterile saline.
- Time after start of exposure: 24h

SCORING SYSTEM:
The ocular reaction was scored according to the following scale (guide issued by U.S. Consumer Product Safety Commission (CPSC)).
The ocular irritation score was evaluated in conjuction with the nature and the reversibility or otherwise of the responses observed.

VALUE "CORNEA
Opacity: degree of density (most dense area taken for reading)"
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 Easily discernible translicent area, details of iris slightly obscured
3 Nacreous area, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity.


VALUE IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combinations of any theof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, hemorrhage, gross destruction (any or all of these)


VALUE "CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)"
0 Blood vessels normal
1 Some blood vessels definitely hyperemic (injected)
2 Diffuse, crimson colour, indivicual vessels not easily discernible
3 Diffuse beefy red

VALUE "CONJUNCTIVAE
Chemosis:lids and /or nictating membranes"
0 No swelling
1 Any swelling above normal (includes nictating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half closed
4 Swelling with lids more that half closed


TOOL USED TO ASSESS SCORE: visual inspection.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

other: 60 min

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

other: 60 min

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

other: 60 min

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

other: 60 min

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

same results in all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Cornea and iris: no modification of this tissues was observed in any animals.
Conjunctivae: no changes were seen at all the observations performed in any treated rabbit.

Other effects:

No animals died.
No clinical signs or behavioral alterations were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article GALDEN LMW when administred by ocular route to rabbit under the experimental conditions adopted, is to be considered "NON IRRITANT" for the eye.

Executive summary:

The purpose of the study was to evaluate the acute eye irritation and/or corrosive effects on the eye following the application of the test article GALDEN LMW.

The test method was in accordance with the EEC Guidelines B.5 and with OECD guidelines 405 (Paris 1981, and subsequent revisions).

Three New Zealand White rabbit were treated with a single administration of 0.1 ml of the test article GALDEN LMW.

Both eyes of each experimental animal selected for the testing were examined within 24 hours before testing started.

The test article was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about 3 -4 seconds in order loss of material. The other eye (the left), remaining untreated, served as control. The eyes of the animals were washed out at 24 hours following the test article administration.

The U.S. Consumer Product Safety Commission (CPSC) guide was used as reference source for evaluating and scoring the reaction.

No clinical signs or behavioural alterations were observed.

No sign of ocular irritancy were seen in all treated animals at all the observations.

The test article GALDEN LMW when administred by ocular route to rabbit under the experimental conditions adopted, is to be considered "NON IRRITANT" for the eye.