Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

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)
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
other: bovine eyes
Details on test animals or tissues and environmental conditions:
Bovine eyes from young cattle were used as soon as possible after slaughter on the same day.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The test substance was tested undiluted (100%).
Duration of treatment / exposure:
The corneas were exposed to the test substance for 10+/-1 minutes at 32+/-1°C.
Thereafter the corneas were incubated with fresh Eagle´s Minimum Essential Medium (MEM) for 120+/-10 minutes.
Observation period (in vivo):
After treatment with the test substance and the following incubation period the opacity of corneas was measured using an opacitometer.
Following final opacity measurement the corneas were incubated with sodium fluoresin on the anterior compartment and after an incubation period of further 90+/-5 minutes the optical density of the posterior compartment was measured at 490nm for the determination of permeability.
Details on study design:
Physiological saline and benzalkonium chloride (10% in physiological saline) were used as negative and positive controls. For each group 3 eyes or corneas were used.

Results and discussion

In vivo

Irritant / corrosive response data:
Negative control: IVIS = -1.0 - 0.1 (historical control range: -1.1 - 1.2)
Positive control: IVIS = 118.7 - 132.5 (historical control range: 93 - 189)
Test substance: IVIS = 26.3 - 37.8

Based on the measured opacities and permeabilites after 10 +/1 minute treatment with undiluted (100%) test substance the range of resulting IVIS (in vitro irritancy score) values was 26.3 to 37.8.

Any other information on results incl. tables

The corneas treated with the test substance showed opacity values ranging from 6 to 10 and permeability values ranging from 1.206 to 1.854. The corneas were translucent after the 10 minutes of treatment with the test substance. A pH effect of the test substance was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from 27 to 38 after 10 minutes of treatment with the test substance.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Based on the results and the fact that the in vitro irritancy score for the substance was below 55.1 it can be concluded that the test substance is not a severe irritant or corrosive.