2-methoxyethyl acrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. The study period was terminated at day 7, therefore only limited information on reversibility.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA 40 CFR 163.81.4

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

the study was terminated at day 7; data on reversibilty is in some of the animals not available.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxyethyl acrylate

EC Number:

221-499-3

EC Name:

2-methoxyethyl acrylate

Cas Number:

3121-61-7

Molecular formula:

C6H10O3

IUPAC Name:

2-methoxyethyl acrylate

Details on test material:

- Name of test material (as cited in study report): Sipomer MCA
- Physical state: clear liquid
- Analytical purity: > 99%
- Lot No.: E169H8

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Skippack Farms, Sippack, PA, USA
- Housing: During the test period, the rabbits were housed in individual stainless steel wire bottomed cages.
- Diet: Fisher Rabbit Pellets; ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-22.2
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

6 animals: single application without washing
3 animals: 30 s

Observation period (in vivo):

7 days
Reading time points: 24, 48 and 72 h as well as 4 and 7 days

Number of animals or in vitro replicates:

6 animals: unwashed eyes after instillation
3 animals: washed eyes after instillation

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 20 mL lukewarm water
- Time after start of exposure: 30 s after instillation

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #4 and #5 (unwashed eyes)

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #6

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal: #2, #3, #4, #5 and #6 (unwashed eyes)

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 8

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3 and #4 (unwashed eyes)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

iris score

Basis:

animal #5

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

iris score

Basis:

animal #6

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal: #3, #4, #5 and #6 (unwashed eyes)

Remarks:

(unwashed eyes)

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritant / corrosive response data:

The test substance was found to be an eye irritant in the unwashed eyes of 6 rabbits. All animals showed effects on the cornea (scores 1-2) and conjunctivae (redness: score 1-3; chemosis: score 1-4). In 3 of 6 animals conjunctival redness was fully reversible within 7 days. Whereas conjunctival oedemas were persistent in all animals at any time during the test. Corneal opacity was only reversed in 1 of 6 animals within the observation period of 7 days. Effects on iris (scores of 1) were observed in 2 of 6 animals and were fully reversible within 7 days. As none of the animals was completely free from signs of eye irritation within the observation period of 7 days and it is unknown whether these effects on the cornea and conjunctiva are transient or persistent within an observation period of 21 days, the test substance needs to be classified into Category 1.
The severity and duration of the irritation to the eyes was reduced in the washed eyes of 3 tested animals. However, in one animal, effects on conjunctival redness and chemosis were not fully reversible within 7 days.

Any other information on results incl. tables

Table 1. Results of the unwashed eyes

 

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae			iris		cornea
		redness	swelling				redness		swelling
1
	24	2	3	0	1
	48	2	4	0	1
	72	2	3	0	1
	4 d	1	3	0	1
	7 d	1	1	0	0
	Average: 24+48+72h	2.0	3.3	0.0	1.0	Time to reversion	Not reversible within 7 d		Not reversible within 7 d	-		7 d
2
	24	2	4	0	2
	48	3	4	0	1
	72	3	4	0	1
	4 d	2	4	0	1
	7 d	0	3	0	2
	Average: 24+48+72h	2.3	4.0	0.0	1.3	Time to reversion	7 d		Not reversible within 7 d	-	Not reversible within 7 d
3
	24	2	4	0	2
	48	3	4	0	2
	72	3	4	0	2
	4 d	3	4	0	2
	7 d	2	4	0	3
	Average: 24+48+72h	2.3	4.0	0.0	2.0	Time to reversion	Not reversible within 7 d		Not reversible within 7 d	-	Not reversible within 7 d
4
	24	2	4	0	2
	48	2	4	0	2
	72	2	4	0	2
	4 d	1	3	0	2
	7 d	0	2	0	2
	Average: 24+48+72h	2.0	4.0	0.0	2.0	Time to reversion	7 d	Not reversible within 7 d		-	Not reversible within 7 d
5
	24	2	4	1	2
	48	2	4	0	2
	72	2	4	0	2
	4 d	2	4	0	2
	7 d	0	3	0	1
	Average: 24+48+72h	2.0	4.0	0.3	2.0	Time to reversion	7 d	Not reversible within 7 d		48 h	Not reversible within 7 d
6
	24	3	4	1	2
	48	3	4	1	2
	72	3	4	1	2
	4 d	2	4	1	3
	7 d	1	4	0	2
	Average: 24+48+72h	3.0	4.0	1.0	2.0	Time to reversion	Not reversible within 7 d		Not reversible within 7 d	7 d	Not reversible within 7 d
Mean out of all 6 rabbits	24+48+72h	2.67	3.88	0.2	1.7

 

Table2. Results of the washed eyes (30 s after instillation)

 

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae			iris		cornea
		redness	swelling				redness	swelling
1
	24	2	3	0	0
	48	0	2	0	0
	72	0	1	0	0
	4 d	0	1	0	0
	7 d	0	0	0	0
	Average: 24+48+72h	0.67	2.0	0.0	0.0	Time to reversion	48 h	7 d		-		-
2
	24	2	4	0	1
	48	2	4	0	1
	72	2	4	0	1
	4 d	2	4	0	1
	7 d	1	2	0	0
	Average: 24+48+72h	2.0	4.0	0.0	1.0	Time to reversion	Not reversible within 7 d		Not reversible within 7 d		-	7 d
3
	24	2	4	0	2
	48	3	4	0	2
	72	3	3	0	2
	4 d	2	2	0	1
	7 d	0	0	0	0
	Average: 24+48+72h	2.67	3.67	0.0	2.0	Time to reversion	7 d	7 d		-		7 d
Mean out of all 6 rabbits	24+48+72h	1.78	3.22	0.0	1.0

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

CLP: Eye damage 1, H318