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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study with detailed documentation, in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
MAEEBP
IUPAC Name:
MAEEBP
Details on test material:
- Name of test material (as cited in study report): MAEEBP- Physical state: colourless liquid- Composition of test material, percentage of components: 4-methacryloyl diethoxy benzophenone 85 area%, impurities: 4-hydroxybenzophenone <5%, 4-methacryloyl benzophenone <5%, polymethacrylate <5%- Lot/batch No.: 150301- Expiration date of the lot/batch: Sep. 2015- Storage condition of test material: The test item was stored in the test facility in a closed vessel in the refrigerator.

Test animals / tissue source

Species:
other: Bos primigenius Taurus (bovine corneas)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: slaughterhouse Müller Fleisch GmbH, Germany- Age at study initiation: fresh eyes, on the day of test. Cattle were between 12 and 60 months old.ENVIRONMENTAL CONDITIONS- Temperature (°C): 32+-1°C- Eyes were transported to the test facility in Hank´s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin)

Test system

Amount / concentration applied:
The test item is a liquid substance. It was tested directly, without dilution or preparation of a solution.
Duration of treatment / exposure:
incubated with test item for 10 min
Details on study design:
SCORING SYSTEM:baseline opacity for each cornea was recordedTOOL USED TO ASSESS SCORE: spectral photometer, 570 nm

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
73.24

Any other information on results incl. tables

The negative control showed no irritating effect on the cornea and the calculated In Vitro Irritancy Score (IVIS) is 0.30. Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and falls within two standard deviations of the current historical mean. The calculated IVIS is 73.24.

Under the conditions of this study, the test item MAEEBP showed no effects on the cornea of the bovine eye. The calculated IVIS is 0.14.

Table 1. Calculated IVIS for each replicate and the corresponding means

Test Group

IVIS

Mean IVIS

Relative Standard Deviation IVIS

Negative Control
0.9% NaCl

0.11

0.30

66.3%

0.29

0.50

Test Item
MAEEBP

0.14

0.14

31.9%

0.19

0.10

Positive Control
DMF undiluted

63.22

73.24

14.1%

72.66

83.84

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test item MAEEBP showed no effects on the cornea of the bovine eye. The calculated IVIS is 0.14.According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

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