Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1998
Reference Type:
publication
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

-

-

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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