Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08/06/2017-22/06/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Qualifier:
according to
Guideline:
other: Direct peptide reactivity Assay (DPRA) for Skin Sensitization Testing, DB-ALM protocol n°154, January 12, 2013
GLP compliance:
yes (incl. certificate)
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Results and discussion

In vitro / in chemico

Results
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: the samples could not be measured

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In this study under the given conditions the test item could not be measured by HPLC due to the turbidity and phase separation of the samples with both peptide solutions. Therefore, the result must be considered as inconclusive.