Reaction products of orthoboric acid with 2,2'-iminodiethanol (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Orthoboric acid, compound with 2-aminoethanol

EC Number:

247-421-8

EC Name:

Orthoboric acid, compound with 2-aminoethanol

Cas Number:

26038-87-9

Molecular formula:

C2H7NO.xBH3O3

IUPAC Name:

orthoboric acid, compound with 2-aminoethanol

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 polborates, 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

Results

Irritation parameter:

in vitro irritation score

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

In vivo

Other effects:

none stated

Any other information on results incl. tables

Table1            Summary of opacity, permeability andin vitroscores

 

Treatment	Mean Opacity^1	Mean Permeability^1	MeanIn vitroIrritation Score^1, 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:

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.

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 colourlessliquidwith 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 rangeindicating that the negative control did not induce irritancy on the corneas.The meanin vitroirritancy 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 notinduce ocular irritation through both endpoints, resulting in a meanin vitroirritancy 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.