Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
