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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
Study period:
10-NOV-2009
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:
2009
Report Date:
2009

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): Silicic acid(H2Si2O5), barium salt(1:1), lead-doped
- Substance type: white powder
- Physical state: powder
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark


Test system

Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea
- Concentration (if solution): 20% (w/v)

VEHICLE
- 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 fluorescein

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


Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
240 min
Value:
ca. 3.1
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
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 (20% w/v Imidazole) was 106 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Although little cracks were observed in all three corneas, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 3.1 after 240 minutes of treatment.

Finally, it is concluded that this test is valid and that Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.