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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:
20 Oct 2014 - 21 Oct 2014
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:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
Adopted July 26, 2013
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Version / remarks:
EAmended by EC No. 1152/2010 No. L142, 09 December 2010
Deviations:
no
Qualifier:
according to
Guideline:
other: 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), March 2006
Deviations:
no
Qualifier:
according to
Guideline:
other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
Deviations:
no
Qualifier:
according to
Guideline:
other: 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 Toxicol 18:442-449, 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Disodium isodecyl sulfosuccinate
- Substance type: organic
- Physical state: White powder
- Storage condition of test material: At room temperature, in a well-sealed container
- pH: 5.7 (1% in water, indicative range)

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount applied: approx. 750 µl of 10% (w/v) dilution in physiological saline per cornea
- The stock solution was treated with ultrasonic waves until the test substance had completely dissolved

NEGATIVE CONTROL
- Amount applied: 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount applied: 750 µl per cornea
Concentration: 10% (w/v) benzalkonium chloride in physiological saline


Duration of treatment / exposure:
10 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing: yes (with MEM with phenol red (Eagle’s Minimum Essential Medium, Invitrogen Corporation) and thereafter with cMEM)
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by incubation for 120 ± 10 minutes in cMEM. Then, corneas were incubated in sodium-fluorescein solution for 90 ± 5 minutes (both incubations at 32 ± 1°C).

- 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 ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces an IVIS > 55 is defined as a corrosive or severe irritan (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≥ 55, no prediction on irritant potency can be made (UN GHS: no prediction can be made)

Results and discussion

Results of ex vivo / in vitro study
Irritation parameter:
in vitro irritation score
Run / experiment:
10 minutes
Value:
38.1
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Irritant / corrosive response data:
The opacity value was 10 in all three corneas treated with disodium isodecyl sulfosuccinate and permeability values ranged from 0.406 to 2.785. The corneas were turbid with spots after the 10 minutes of treatment with disodium isodecyl sulfosuccinate. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from 15.8 to 51.4 after 10 minutes of treatment with Disodium isodecyl sulfosuccinate.

Any other information on results incl. tables

The individual in vitro irritancy scores for the negative controls ranged from -0.4 to 0.7. The individual positive control in vitro irritancy scores ranged from 156 to 168 for benzalkonium chloride (mean IVIS = 161.6). The corneas treated with the positive control substance were turbid after the 10 minutes of treatment.

Applicant's summary and conclusion

Interpretation of results:
other: the outcome alone does not allow conclusion on classification
Remarks:
Criteria used for interpretation of results: other: UN GHS
Conclusions:
In a bovine corneal opacity and permeability (BCOP) test, performed according to OECD guideline and GLP principles, disodium isodecyl sulfosuccinate induced a mean IVIS of 38.1. Based on an IVIS > 3 and ≤ 55, no prediction on eye irritancy of the test substance can be made.

Executive summary:

A bovine corneal opacity and permeability (BCOP) test was performed with disodium isodecyl sulfosuccinate according to OECD guideline and GLP principles. Reliable positive and negative controls were included. The corneas treated with disodium isodecyl sulfosuccinate were turbid with spots after the 10 minutes of treatment. Mean in vitro irritancy score was 38.1 after 10 minutes of treatment. The opacity value was 10 in all three corneas treated with disodium isodecyl sulfosuccinate and permeability values ranged from 0.406 to 2.785. based on an IVIS > 3 and ≤ 55, no conclusion on classification for eye irritancy can be drawn according to GHS UN based on this study alone.