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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
Study period:
09.04.1984 - 03.05.1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Well documented guideline study. Observation period only 7 days instead of 21 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Journal Officiel de la Republique Francaise 21 April 1971 and 5 June 1973
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methacrylic anhydride
EC Number:
212-084-8
EC Name:
Methacrylic anhydride
Cas Number:
760-93-0
Molecular formula:
C8H10O3
IUPAC Name:
2-methylprop-2-enoyl 2-methylprop-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Methacrylic anhydride (AMA 20)
- Analytical purity: not stated
- Impurities (identity and concentrations):
- Lot/batch No.: not stated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Supplied by Nottingham University.& School of Agriculture, Sutton Bonington, Leics.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.60-3.10 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): free access to a standard laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire) ad libitum.
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: minimum period of five days prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-4.5
- Humidity (%): 50-60 %
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/darl cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and was used for control purposes.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
On the day of the test a 0.1 ml aliquot of the test material was instilled into one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The eyelids were then held together for approximately one second and the animal released. The contralateral eye remained untreated and was used for control purposes.
Observation period (in vivo):
Assessment of damage/irritation was made 1, 2, 3, 4 and 7 days following treatment
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM: (Draize J.H. 1959, Assoc. of Food and Drug Officials of the USA, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Examination of the eye was facilitated by the use of a
standard ophthalmoscope (Keeler) ~ Observation of corneal opacity may be carried out under ultra-violet illumination (Mineralight
UVSL-58) preceded by the instillation into the eye of 0.05 ml of fluorescein B.P.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: observation time only 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: # 4 and 6
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: observation time only 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: observation time only 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: observation time only 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: observation time only 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: observation time only 7 days

Any other information on results incl. tables

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)

1

2

3

2

Glanzlos

n.d.

 

2)

2

2

2

2

2

n.d.

 

3)

2

2

2

2

2

n.d.

 

4)

1

2

2

1,67

1

n.d.

 

5)

1

1

1

1

3

n.d.

 

6)

1

2

2

1,67

Glanzlos

n.d.

 

 

1,33

1,83

2

1,72

 

 

 

 

 

 

 

 

 

 

 

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)

1

1

1

1

0

n.d.

 

2)

1

1

1

1

0

n.d.

 

3)

1

1

1

1

0

n.d.

 

4)

1

1

1

1

0

n.d.

 

5)

1

1

1

1

1

n.d.

 

6)

1

1

1

1

0

n.d.

 

 

1

1

1

1

0,17

 

 

 

 

 

 

 

 

 

 

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)

3

3

3

3

2

n.d.

 

2)

3

3

3

3

2

n.d.

 

3)

3

3

3

3

2

n.d.

 

4)

3

3

3

3

2

n.d.

 

5)

3

3

3

3

3

n.d.

 

6)

3

3

3

3

2

n.d.

 

 

3

3

3

3

2,17

 

 


 

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)

4

4

4

4

2

n.d.

 

2)

4

4

4

4

3

n.d.

 

3)

4

4

4

4

3

n.d.

 

4)

4

4

4

4

2

n.d.

 

5)

4

4

4

4

3

n.d.

 

6)

4

4

4

4

3

n.d.

 

 

4

4

4

4

2,67

 

 

 

 

Classification:

Hazard Category

 

1

because there is no reversibility after 7 d

 




n.d. = no data

 

Classification Criteria for serious Eye Damage/Eye Irritation

 

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:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Methacrylic anhydride was tested in an eye irritation test. The mean scores for corneal opacity , iritis and conjunctiva were not reversible within 7 days. Therefore methacrylic anhydride is classified into Category 1 (irreversible effects on the eyes).
Executive summary:

Methacrylic anhydride was tested in an eye irritation test. The mean scores for corneal opacity , iritis and conjunctiva were not reversible within 7 days. Therefore methacrylic anhydride is classified into Category 1 (irreversible effects on the eyes).