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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-Jun-2010 to 15-Jun-2010
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:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4,4’-Methylene bis (2-chloroaniline)
- Substance type: Light yellow granules
- Physical state: Solid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 357 to 381 mg per cornea
- Concentration (if solution): 20% (w/w)

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): 20% (w/v) Imidazole
Duration of treatment / exposure:
240 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- 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: 240 minutes
Score:
8.1
Other effects:
- The corneas were clear after the 240 minutes of treatment with 4,4’-Methylene bis (2-chloroaniline).
- No pH effect of the test substance was observed on the rinsing medium.

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.

4,4’-Methylene bis (2-chloroaniline) did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 8.1 after 240 minutes of treatment.

Finally, it is concluded that this test is valid and that 4,4’-Methylene bis (2-chloroaniline) is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.