Registration Dossier
Registration Dossier
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EC number: 823-458-0 | CAS number: 1631149-46-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 6,6'-(1-phenylethane-1,2-diyl)bis(6H-dibenzo[c,e][1,2]oxaphosphinine) 6,6'-dioxide
- EC Number:
- 823-458-0
- Cas Number:
- 1631149-46-6
- Molecular formula:
- C32H24O4P2
- IUPAC Name:
- 6,6'-(1-phenylethane-1,2-diyl)bis(6H-dibenzo[c,e][1,2]oxaphosphinine) 6,6'-dioxide
- Test material form:
- solid: particulate/powder
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Lysine DPRA depletion
- Value:
- 5.8
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Acetonitrile : Dimethylsulphoxide solution 50:50 (v/v) was chosen as test chemical solvent for dissolution of DIDOPO HTP-6123 at a concentration of 50 mM instead of 100 mM, considering poor solubility of Test Chemical in all the solvent tested.
As stated in the method and in the guidelines (section 29 OECD/OCDE TG 442C) determination of reactivity cannot be made based on the Percent depletion data from the Lysine reaction alone.
Only Lysine DPRA was obtained on the present study since no System Suitability was obtained in the case of Cysteine DPRA, probably due to degradation of Cysteine peptide in the Test Chemical solubilisation solvent (Acetonitrile : Dimethylsulphoxide solution 50:50 (v/v)).
For these reasons data obtained should be reported as “inconclusive” as indicated in SOPa 170 Rev.1.
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