Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-butylmethacrylat
- Physical state: liquid
- Analytical purity: 99.8%, stabilized with 100 ppm hydroquinonemonomethylether
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemall GmbH & Co. KG
- Age at study initiation: 8-10 W
- Weight at study initiation: no data
- Housing: individually
- Diet (e.g. ad libitum): mümmel z, ssniff/Soest
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 40 - 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
The test eyes were not washed out following the instillation
Observation period (in vivo):
1, 24, 48 and 72 hours as well as 8 days 
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24+48+72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observation time: 8 days
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24+48+72 h
Score:
0
Max. score:
2
Remarks on result:
other: Observation time: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3
Time point:
other: mean 24+48+72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Observation time: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24+48+72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observation time: 8 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
other: mean 24+48+72 h
Score:
0
Max. score:
4
Remarks on result:
other: Observation time: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24+48+72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Observation time: 8 days
Irritant / corrosive response data:
One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal.  The second animal also exhibited conjunctival redness at 24 hours after dosing.  At 48 hours following dosing all signs of irritation had resolved.  The remaining animal showed no signs of irritation at any time during the test.

Any other information on results incl. tables

Classification of eye irritation studies according GHS-criteria

 

Substance:n-Butyl methacrylate                     CAS: 97-88-1

 

Source: UNTER 88-022

 

 

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 

Mean Draize score in 2 of 3 animals

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

0

0

0

0

0

 

 

 

 

 

 

0

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

 

Mean Draize score in 2 of 3 animals

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

0

0

0

0

0

 

 

 

 

 

 

0

 

 

none

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva redness (erythem) /Bindehautrötung[Scores]

 

Mean Draize score in 2 of 3 animals

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

1

0

0

0.33

0

 

 

2

0

0

0

0

0

 

 

3

1

0

0

0.33

0

 

 

 

 

 

 

 

 

 

none


 

Animal No.

Conjunctiva chemosis /Bindehautödem[Scores]

 

Mean Draize score in 2 of 3 animals

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

0

0

0

0

0

 

 

2

0

0

0

0

0

 

 

3

1

0

0

0.33

0

 

 

 

 

 

 

 

 

 

none

 

 

Classification:

Hazard Category

 

none

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
Classification: not irritating
Executive summary:

In an OECD 405 guideline study, n-butyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits.   The lids were then gently held together for one second.   The test eyes were not washed out following the instillation.   The left eye remained untreated for control.   The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test.   Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge).   Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal.   The second animal also exhibited conjunctival redness at 24 hours after dosing.   At 48 hours following dosing all signs of irritation had resolved.   The remaining animal showed no signs of irritation at any time during the test. n-Butyl methacrylate is considered as slightly irritating to eyes.