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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:
29-Nov-2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.47 “Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate
- Substance type: Clear colourless or slightly yellow, sticky resin
- Physical state: Solid
- Storage condition of test material: At room temperature protected from light

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl, The test substance was applied as it is directly on top of the corneas

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride
Duration of treatment / exposure:
- Exposure: 10 minutes
- Post incubation period: 120 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 minutes at 32 °C. After the completion of the incubation period opacity determination was performed.a.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

- In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vivo

Results
Irritation parameter:
other: In vitro irritancy score (IVIS)
Basis:
mean
Time point:
other: 10 minutes
Score:
2.6

Applicant's summary and conclusion

Interpretation of results:
other: not severe irritant or corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The positive and negative controls were within the historical control data.

Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test

Executive summary:

Reaction products of 1,1’-methylenebis(4-isocyanatocyclohexane) and pentaerythritol triacrylate and pentaerythritol tetraacrylate did not induce ocular irritation through both endpoints, resulting in a mean in vitro rritancy score of 2.6 after 10 minutes of treatment.

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