2,2,2-trifluoroethyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1985-05-13 to 1985-05-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,2-trifluoroethyl methacrylate

EC Number:

206-525-3

EC Name:

2,2,2-trifluoroethyl methacrylate

Cas Number:

352-87-4

Molecular formula:

C6H7F3O2

IUPAC Name:

2,2,2-trifluoroethyl methacrylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): MATRIFE

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.48 – 2.69 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): standard laboratory diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5±1.5°C
- Humidity (%):50-55%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated contralateral eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

eyes were not rinsed after application

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Conjunctival redness (grade 1, some blood vessels hyperaemic (injected)) was observed in 3/3 animals after 1 h and in 2/3 animals after 24 h. Grade 1 chemosis was observed in 1/3 animals after 1 h, which had recovered at the 24 h time point. No irritation was noted at the 48 and 72 h observations.

Any other information on results incl. tables

Rabbit number	reaction	Scores 1/24/48/72 h
1	Cornea, opacity	0/0/0/0
	Iris	0/0/0/0
	Conjunctivae, redness	1/1/0/0
	Conjunctivae, chemosis	0/0/0/0
	Conjunctivae, discharge	0/0/0/0
2	Cornea, opacity	0/0/0/0
	Iris	0/0/0/0
	Conjunctivae, redness	1/1/0/0
	Conjunctivae, chemosis	1/0/0/0
	Conjunctivae, discharge	0/0/0/0
3	Cornea, opacity	0/0/0/0
	Iris	0/0/0/0
	Conjunctivae, redness	1/0/0/0
	Conjunctivae, chemosis	0/0/0/0
	Conjunctivae, discharge	0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study TFMEA was not irritating to the eye.

Executive summary:

In a primary eye irritation study according to OECD guideline 405, 0.1 mL of undiluted TFMEA (not given in the study report, but according to sponsor >90%) was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand white rabbits. The eyes were not rinsed after application. Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

Only minimal irritation was observed:Conjunctival redness (grade 1, some blood vessels hyperaemic (injected)) was observed in 3/3 animals after 1 h and in 2/3 animals after 24 h. Grade 1 chemosis was observed in 1/3 animals after 1 h, which had recovered at the 24 h time point. No irritation was noted at the 48 and 72 h observations.

In this study, TFMEA is not an eye irritant.