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:
weight of evidence
Study period:
2018-04-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 (incl. certificate)
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Results
Key result
Remarks on result:
not measured/tested
Remarks:
result will be given as soon as possible

Applicant's summary and conclusion

Conclusions:
Skin sensitizing properties of the test item will be assessed and the result will be given as soon as possible.
Executive summary:

A test battery is currently conducted according to OECD TG 442C, 442D and 442E to determine the skin sensitizing properties of the test item in vitro. The result will be given later. The study was initiated before 31 March 2018 but was not completed by the CRO in due time to complete the registration dossier. The study record will be updated as soon as the results will become available.