Registration Dossier

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:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Lysine DPRA depletion
Value:
ca. 5.8
Positive controls valid:
yes

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.