Complexation products of sodium tartrate with iron trichloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 July 2010 - 26 July 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This 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

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Organisation for Economic Co-operation and Development (OECD), OECD Guideline for Testing of Chemicals; Guideline no. 437: "Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants" adopted 07-09-09

Deviations:

no

Principles of method if other than guideline:

- The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006
- In Vitro Techniques in Toxicology Database (INVITTOX) protocol 124. Bovine Opacity and Permeability Assay - SOP of Microbiological Associates Ltd., 1999.
- Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl ToxicoI18:442-449, 1992.

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea


POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl Benzalkonium Chloride per cornea
- Concentration (if solution): 10% (w/v)
- Lot/batch no. (if required): S4214644 442

- Amount(s) applied (volume or weight with unit): 750 µl ethanol per cornea
- Lot/batch no. (if required): K40023527920

Duration of treatment / exposure:

- Treatment period: 10 minutes
- Incubation period: 2 hours

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 exposure the cornea is thoroughly rinsed to remove the test substance and incubated for 2 hours with fresh medium followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.
- - 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:
In vitro score range / In vitro classification
0 - 3 / Non irritant
3.1 - 25 / Mild irritant
25.1 - 55 / Moderate irritant
55.1 - 80 / Severe irritant
> 80 / Very severe irritant

Results and discussion

In vivo

Results

Irritation parameter:

other: In vitro irritancy score (IVIS)

Basis:

mean

Time point:

other: 10 minutes exposure/ 120 minutes incubation

Score:

0.1

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

It is concluded that this test is valid and that the test substance is not irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

Executive summary:

Screening for the eye irritancy potential of Complexation products of sodium tartrate with iron trichloride using the Bovine Corneal Opacity and Permeability test (BCOP test).

This report describes the ocular irritation properties of Complexation products of sodium tartrate with iron trichloride on an isolated bovine cornea. The possible ocular irritancy of Complexation products of sodium tartrate with iron trichloride was tested through topical application for 10 ± 1

minutes.

The study procedures described in this report were based on the most recent OECD guideline. 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 134 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.

Complexation products of sodium tartrate with iron trichloride did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.1 after 10 minutes of treatment.

Finally, it is concluded that this test is valid and that Complexation products of sodium tartrate with iron trichloride is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.