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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-07-27 to 1993-07-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24th February 1987
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid
- Analytical purity: 99.94%

- Name of test material (as cited in study report): 2-ethoxyethyl methacrylate, MAEE

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.6 ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test substance.
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: according to OECD guideline 405


TOOL USED TO ASSESS SCORE: fluorescein (only for 24 h observation)

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
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A slight redness (grade 1) of the conjunctiva was noted in 2/3 animals after 1 hour. No ocular reactions were observed 24, 48 and 72 hours after treatment.

Any other information on results incl. tables

 

Rabbit number

reaction

Scores after

1/24/48/72 h

1

Conjunctivae, chemosis

0/0/0/0

Conjunctivae, redness

0/0/0/0

Conjunctivae, discharge

E/0/0/0

Iris

0/0/0/0

Cornea, opacity

0/0/0/0

2

Conjunctivae, chemosis

0/0/0/0

Conjunctivae, redness

1/0/0/0

Conjunctivae, discharge

E/0/0/0

Iris

0/0/0/0

Cornea, opacity

0/0/0/0

3

Conjunctivae, chemosis

0/0/0/0

Conjunctivae, redness

1/0/0/0

Conjunctivae, discharge

E/0/0/0

Iris

0/0/0/0

Cornea, opacity

0/0/0/0

E =Scoring obscured by residual test substance

max scores: conjunctival chemosis: 4, conjunctival redness: 3, conjunctival discharge: 3, iris lesions: 2, corneal lesions: 4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
ETMA is not irritating to the rabbit eye.
Executive summary:

In a primary eye irritation study according to OECD guideline 405, adopted 24 February 1987, 0.1 mL of ETMA (99.94% a.i.) was instilled into the conjunctival sac of 3 young adult New Zealand White rabbits without washing. The untreated right eye served as control. Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

Slight redness (grade 1) of the conjunctiva was noted in 2/3 animals after 1 hour. No ocular reactions were observed 24, 48 and 72 hours after treatment. 

In this study, ETMA is not irritating to the rabbit eye.