2-methoxyethyl methacrylate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24th February 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxyethyl methacrylate

EC Number:

219-135-3

EC Name:

2-ethoxyethyl methacrylate

Cas Number:

2370-63-0

Molecular formula:

C8H14O3

IUPAC Name:

2-ethoxyethyl methacrylate

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

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, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

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:

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.