2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 405. GLP. Meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1998

Reference 3

Reference Type:

publication

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 February 1987

Deviations:

no

GLP compliance:

yes

Remarks:

adopted 12th May 1981

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate

EC Number:

254-588-0

EC Name:

2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate

Cas Number:

39670-09-2

Molecular formula:

C12H22O5

IUPAC Name:

2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate

Constituent 2

Reference substance name:

Ethyltriglycol methacrylate

IUPAC Name:

Ethyltriglycol methacrylate

Details on test material:

- Name of test material (as cited in study report): Methacrylate d'ethyltriglycol (ETGMA)
- Substance type: organic
- Physical state: liquid
- Supplier: Elf Atochem S.A., 92091 Paris, France
- Storage condition of test material: + 4°C and protected from light

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: New Zealand White rabbits, Supplier: Elevage Cunicole du Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.9 ±0.05 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm)
- Diet: ad libitum during study
- Water: ad libitum during study
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 50 ±20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each treated animal serves as controll

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml
The eyes were not rinsed after administration of the test substance.

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

21 days after treatment

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Irritant / corrosive response data:

One hour after instillation of the test substance, some moderate conjunctival reactions (chemosis and redness, score of 2) in 2 animals and marked conjuctival reactions (chemosis, score of 4 and redness, score of 3) in one animal were observed. No iridic or corneal damages were noted in the 3 animals. No ocular reactions were noted thereafter (24, 48 and 72 hours after instillation).

Any other information on results incl. tables

MMAS (Modified Maximum Average Score) (0+0+0)/3 = 0

Classification of eye irritation studies according OECD-GHS-criteria

Substance: Ethyltriglycol methacrylate                                                     CAS: 39670 -09 -2

Internal No.: LITSU 01-0120

Date/Expert: 06 -02 -2012/RG

Animal No.	Corneal opacity/Hornhauttrübung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	-	-
2	0	0	0	0	-	-
3	0	0	0	0	-	-
							none
Animal No.	Iritis/Regenbogenhautentzündung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	-	-
2	0	0	0	0	-	-
3	0	0	0	0	-	-
							none
Animal No.	Conjunctiva redness (erythem) /Bindehautrötung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	-	-
2	0	0	0	0	-	-
3	0	0	0	0	-	-
							none

Animal No.	Conjunctiva chemosis /Bindehautödem[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	-	-
2	0	0	0	0	-	-
3	0	0	0	0	-	-
							none

Classification: Hazard Category

none

Classification Criteria for serious Eye Damage

Category 1

- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal

- Mean Draize score in 2 of 3 animals:

corneal opacity ≥ 3

iritis ≥ 1,5

Category 2

- Reversible adverse effects on cornea, iris, conjunctiva

- Mean Draize score in 2 of 3 animals:

corneal opacity >= 1

iritis >= 1

redness >= 2

chemosis >= 2

Subcategory 2A

- Reversible in 21 days

Subcategory 2B

- Reversible in 7 days

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating

Executive summary:

In a primary eye irritation study according to OECD 405 0.1 mL undiluted Ethyltriglycol methacrylate was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits, (body weight at study initiation: 2.9 ±0.05 kg) for 72 hours. The animals were observed for 21 days. Irritation was scored according to Draize scoring and evalutated according OECD-GHS criteria.

In this study Ethyltriglycol methacrylat is not irritating to eyes.

OECD GHS Category: none

EU GHS Category: none

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