Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
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:
- 2 009
- 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. QA statement)
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.
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