[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28/Mar/02 - 28/Feb/03

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether

EC Number:

609-858-6

Cas Number:

406-78-0

Molecular formula:

C4H3F7O

IUPAC Name:

1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether

Test material form:

liquid

Specific details on test material used for the study:

Sponsor's identification: 2,2,2-Trifluoroethyl-1,1,2,2-Tetrafluoroethyl-Ether (CAS 406-78-0)
Description: Clear colourless liquid
Batch number: S728010
Date received: 09 September 2002
Storage conditions: Room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White rabbits were used for the study. At the start of the study, the animals were in the weight range of 2.0-3.5kg and were 12-20 weeks old. After an acclimitisation period of at least 5 days, each animal was given a unique number within the study, which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30-70% respectively. The rate of air exchange was at least 15 changes per hour and the lighting was controlled by a time switch to give 12 hours of continuous light (06:00 to 18:00), followed by 12 hours of darkness.
The animals were provided with environmental enrichment items, which were considered not to contain any level of contaminant that might have affected the purpose or integrity of the study.

Test system

Vehicle:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

1 second

Observation period (in vivo):

72 hours

Details on study design:

Immediately before the start of the test, both eyes of the provisionally selected rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard opthalmoscope. Only animals free of ocular damage were used for the study.
Initially, a single rabbit was treated. A volume of 0.1ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain was made according to the classification in table 1.

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. Assessment of the ocular damage/ irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize Scale for scoring Ocular Irritation. Any other effects were also noted. Examination of the eye was facilitated by the use of the light source from the standard ophthalmoscope.

The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris were designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of the cornea involved). For each tissue, the score was calculated as follows:
Score for conjuctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained, a modified version of the Kay and Calandra Interpretation of the Eye Irritation Test was used to classify the ocular irritancy potential of the test material. The was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated and the highest of these group means (the maximum group mean score), together with the persistence of the reactions, enabled classification of the eye irritancy potential of the test material.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1h

Score:

8

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1h

Score:

8

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1h

Score:

8

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Results 16

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 17

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 18

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

No corneal or irridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment, with minimal conjunctival irritation in one treated eye at the 24-hour observation. Two treated eyes appeared normal at the 24-hour observation and the remaining treated eye appeared normal at the 48-hour observation.

Any other information on results incl. tables

The table below summarises the individual and group mean scores for ocular irritation:

Rabbit number and sex	IPR = 2					IPR = 2				IPR = 2
	90 Male					61 Male				62 Male
Time after treatment	1h	24h	48h		72h	1h	24h	48h	72h	1h	24h	48h	72h
CORNEA
E = Degree of Opacity	0	0	0	0		0	0	0	0	0	0	0	0
F = Area of Cornea involved	0	0	0	0		0	0	0	0	0	0	0	0
Score (E x F) x 5	0	0	0	0		0	0	0	0	0	0	0	0
IRIS
D	0	0	0	0		0	0	0	0	0	0	0	0
Score D x 5	0	0	0	0		0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	1	0	0	0		1	1	0	0	1	0	0	0
B = Chemosis	1	0	0	0		1	0	0	0	1	0	0	0
C = Discharge	2	0	0	0		2	0	0	0	2	0	0	0
Score (A + B + C) x 2	8	0	0	0		8	2	0	0	8	0	0	0
Total Score	8	0	0	0		8	2	0	0	8	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a maximum group mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye, according to a modified Kay and Calandra classification system.

Executive summary:

A study was conducted to assess the irritancy potential of the test material 1,1,2,2-tetrafluoroethyl-2,2,2-trifluoroethyl ether to the eye of the New Zealand Rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Two treated eyes appeared normal at the 24 -hour observation and the remaining treated eye appeared normal at the 48 -hour observation.

The test material produced a maximum mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye, according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.