Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Chemical structure
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 2-methylprop-2-enoate
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

Resultsopen allclose all
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
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
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
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
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
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.