Registration Dossier
Registration Dossier
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EC number: 937-913-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-04-17 to 2012-04-19
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic HCE test method
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- IUPAC Name:
- Reaction mass of tri- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ -(acetato-O)-di- µ -(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Reference substance name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- EC Number:
- 700-806-9
- Molecular formula:
- C42H87Mn2N6O6 and C36H75Mn2N6O6
- IUPAC Name:
- Reaction mass of tri-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese and µ-(acetato-O)-di-µ-(2-ethylhexanoato-O)-bis(N,N',N''-trimethyl-1,4,7-triazacyclononane-N,N',N'')dimanganese
- Details on test material:
- - Name of test material (as cited in study report): Manganese Octoate/Acetate - MeTACN complex
Description : white solid
Batch number : 16D16603
Purity : >99%
Storage conditions : room temperature in the dark under nitrogen
Constituent 1
Constituent 2
Test system
- Vehicle:
- water
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Remarks:
- after 10 mins exposure
- Value:
- 90.8
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Results
| Item | Mean Tissue Viability | Mean OD540 | % Viability |
| Negative Control | 0.909 | 0.9 | 100* |
| 0.891 | |||
| Positive Control | 0.212 | 0.196 | 21.8 |
| 0.179 | |||
| Test Item | 0.834 | 0.817 | 90.8 |
| 0.799 |
* = The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Executive summary:
As yet there are no EU approved in-vitro test methods for eye irritation.The Episkin method is on the list of tests listed in ECHA Guidance Note R.7a. suitable for determination of eye irritation. It has been submitted for ECVAM approval and a pre-validation document is attached.
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