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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-guideline study but comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
Principles of method if other than guideline:
Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glykoldimethacrylat

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50 - 60 %
- 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
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hours, unrinsed
Observation period (in vivo):
7 days after treatment
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: not rinsed
Irritation parameter:
other: index of primary eye irritation
Basis:
mean
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
13
Reversibility:
fully reversible
Remarks on result:
other: re-evaluated according to OECD405

Any other information on results incl. tables

Index of primary eye irritation: 0.0 of 13 (re-evaluated according to OECD 405)

An initial slight irritation of the conjunctiva within the first 8 hours

(irritation scores 0-1) disappeared entirely within the first 24 h; non-irritating

Classification of eye irritation studies according OECD-GHS-criteria

Substance: Ethylene glycol dimethacrylate                                                     CAS: 97 -90 -5

Internal No.: UNTER78 -007

Date/Expert: 15 -12 -2011/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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 0

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, 2

0  0

0  0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 0

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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 0

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, 2

0 0

0 0

0 0

0 0

0 0

-

3, 4

0 0

0 0

0 0

0 0

0 0

-

5, 6

0 0

0 0

0 0

0 0

0 0

-

             

 none

Classification:

Hazard Category

none

Classification Criteria for serious Eye Damage/Eye

Category 1

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

- Mean Draize score in 2 of 3 canimals:

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 pre-guideline eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)) 0.1 mL undiluted Ethyleneglycol dimethacrylate was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.

In this study Ethyleneglycol dimethacrylat is not irritating to eyes.

OECD GHS Category: none

EU GHS Category: none

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