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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to Draize-method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize
Principles of method if other than guideline:
other: 0.1 ml (undiluted), 6 animals/dose group, scoring in accordance with Draize method; observation perid: 7 days
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
glacial MAA, three different batches
Code 6-5246; Lot 311910

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
1, 24, 48 and 72 hours, 7 days
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Results
Irritation parameter:
other: Primary irritation index
Basis:
mean
Remarks:
according to Scoring system of Draize et al. 1944
Time point:
other: 24, 48, 72 hours
Score:
102.77
Max. score:
110
Reversibility:
not reversible
Irritant / corrosive response data:
severe corneal, iridial and conjunctival effects persisting through the 7th day.
Total average scores (cornea, iris, conjunctiva) for 1, 24, 48 and 72 hours, and 7 days were 86.0, 92.0, 96.4, 99.7 and 103.3, respectively. In addition, chemical burns (6/6), epithelial sloughing (5/6), and hypopyon (3/6) were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
In a scientifically valid study, methacrylic acid was highly irritating to the rabbit eye.
Executive summary:

In a scientifically valid study, methacrylic acid was highly irritating to the rabbit eye.