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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Bovine corneal opacity and permeability test (BCOP test)
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):MEA Polyborate 1:3
- Molecular formula (if other than submission substance):MEA Polyborate cannot be represented with a simple structural formula. MEA Polyborates are complex mixtures of HO(CH2)2NH4+ salts, borate esters, and various polyborates, all existing in rapid equilibrium.
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:reaction product
- Physical state:clear colourless liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:68% salt in water
- Isomers composition:
- Purity test date:
- Lot/batch No.:EU-SMG 01696
- Expiration date of the lot/batch:2011-04-02
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:stable
- Storage condition of test material:room temperature in the dark
- Other:

Test animals / tissue source

Species:
other: bovine
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
750 microlitres
Duration of treatment / exposure:
10 minutes
Observation period (in vivo):
10 minutes
Number of animals or in vitro replicates:
not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Value:
0
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Remarks:
mean
Value:
0
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Table1            Summary of opacity, permeability andin vitroscores

 

Treatment

Mean

Opacity1

Mean

Permeability1

MeanIn vitroIrritation Score1, 2

Negative control

0

0.000

0

Positive control

(Benzalkonium Chloride)

82

4.144

144

MEA Polyborate 1:1

0

-0.001

0.0

 

1     Calculated using the negative control mean opacity and mean permeability values.

2     In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490value).

 

Applicant's summary and conclusion

Interpretation of results:
other: not severe irritant or corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
MEA Polyborate 1:3 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
Executive summary:

Screening for the eye irritancy potential of MEA Polyborate 1:3 using the Bovine Corneal Opacity and Permeability test (BCOP test).

 

This summary describes the ocular irritation properties of MEA Polyborate 1:3 on an isolated bovine cornea. The possible ocular irritancy of MEA Polyborate 1:3 was tested through topical application for 10 ± 1 minutes.

 

Batch EU-01696 of MEA Polyborate 1:3 was a clear colourless liquid with a purity of 68% salt in water. The test substance was applied as it is (750 µl) directly on top of the corneas.

 

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

MEA Polyborate 1:3 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.0 after 10 minutes of treatment.

 

Finally, it is concluded that this test is valid and that MEA Polyborate 1:3 is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.