Registration Dossier

Administrative data

Description of key information

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

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
Reference:
Composition 0
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 information:
Composition 1
Key result
Remarks on result:
not measured/tested
Remarks:
result will be given as soon as possible
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.

Endpoint:
skin sensitisation: in vitro
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
GLP compliance:
yes (incl. certificate)
Type of study:
activation of keratinocytes
Test material information:
Composition 1
Key result
Remarks on result:
not measured/tested
Remarks:
result will be given as soon as possible
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.

Endpoint conclusion
Additional information:

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.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
There are no experimental test data available yet. Classification and Labelling assessment under Regulation (EC) No 1272/2008 will be performed as soon as results are available.