Registration Dossier
Registration Dossier
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EC number: 942-770-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2009
- 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 substance name:
- ELDEW PS-308
- IUPAC Name:
- ELDEW PS-308
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approx. 100 µL
- Duration of treatment / exposure:
- Exposure times:
3, 30, 60 min for test item.
60 min for negative control
4, 15, 45 min for positive control.
Items were rinsed off from the tissue models and MTT solution incubation for 3 hrs started. After that OD measurement at 570 nm.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Cell viability in test item group (% of untreated control)
- Run / experiment:
- 3, 30, 60 min
- Value:
- ca. 82 - ca. 106
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- An ET50 value of the test item was determined to be above 60 min.
Any other information on results incl. tables
Cell viability in test item group (in % of untreated control after 3, 30 or 60 min): 106, 86 or 82%.
OD mean score (in test group after 3, 30 or 60 min): 2.279, 1.852 or 1.762
Negative control: 2.154
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study gave no indications for an eye irritation potential of the test item.
- Executive summary:
This study gave no indications for an eye irritation potential of the test item.
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