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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
"Evaluation of the EpiOcular Tissue Model as an Alternative to the Draize Eye Irritation Test" by Stern M et al, Toxicology in vitro 12, 455-461 (1998) as well as the "Ocular Irritation Protocol: Neat Method (MTT ET-50) for Use with EpiOcular Tissue Model (OCL-200)" by the MatTekCorporation, Ashland MA 01721, USA
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Details on study design:
OCL-200 kit and MTT-100 kit (from MatTek Corp., Ashland MA 01721, USA)

OCL-200: 24 EpiOcularTM tissue models, lot# 8089, Kit A, Date: 11/24/2008 - Assay mdium, lot#112108AHB, ExpDate: 12/2/08 - Dulbecco's PBS, lot# 111108Ida, ExpDate: 11/11/09

MTT-100: MTT concentrate, lot# 111308, Exp.Date: 01/13/09 - MTT diluent, lot#487891 - MTT extractant solution, lot# G21B31, ExpDate: 11/10/10

Results and discussion

In vivo

Results
Irritation parameter:
other: cell viability
Time point:
other: 3, 30, 60 min
Score:
82 - 106
Max. score:
106
Reversibility:
other: not relevant: in vitro assay
Remarks on result:
other: EpiOcular Tissue model
Irritant / corrosive response data:
An ET50 value of the test item was determined to be above 60 min.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Cell viability in test item group (in % of untreated control)
after 3 min: 106%; after 0,5 hr: 86%; after 1 hr: 82%

OD mean score
3 min: 2.279 in test item group
0.5 hr: 1.852 in test item group
1 hr: 1.762 test item group (negative control: 2.154)

The test item is non-corrosive.The test item should be categorised as non/minimal irritant.