Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)
Details on the study design:
Skin sensitisation (In chemico test system) - Details on study design:
according to guideline
Positive control results:
the positive control with cinnamaldehyde (100 mM) gave a mean depletion rate of 74.26% confirming the validity of the testsystem.
Key result
Run / experiment:
other: 1
Parameter:
other: cystein peptide depletion
Value:
0
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2
Parameter:
other: cystein peptide depletion
Value:
0
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 3
Parameter:
other: cystein peptide depletion
Value:
0
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 1
Parameter:
other: lysine peptide depletion
Value:
0
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2
Parameter:
other: lysine peptide depletion
Value:
0.92
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 3
Parameter:
other: lysine peptide depletion
Value:
0
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
detailed results on peptide depletion are provided in the table attached as background material
Interpretation of results:
other: the substance did not show peptide reactivity
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OECD 442E human cell line activation test (h-CLAT)
Version / remarks:
2016
GLP compliance:
yes (incl. QA statement)
Type of study:
activation of dendritic cells
Details on the study design:
Skin sensitisation (In vitro test system) - Details on study design:
according to test guideline
Positive control results:
the results obtained with the positive control substances confirmed the sensitivity of the test system.
Key result
Run / experiment:
other: 1 from 971 to 3480 µM for CD86
Parameter:
other: Relative Fluorescence Intensity
Value:
58
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2 from 971 to 3480 µM for CD86
Parameter:
other: Relative Fluorescence Intensity
Value:
37
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 1 from 971 to 3480 µM for CD54
Parameter:
other: Relative Fluorescence Intensity
Value:
120
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2 from 971 to 3480 µM for CD54
Parameter:
other: Relative Fluorescence Intensity
Value:
4
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
detailed results of the hCLAT test are provided in the table attached as background material
Interpretation of results:
other: the substance gave a negative result in the h-CLAT assay
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Version / remarks:
2015
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
activation of keratinocytes
Details on the study design:
Skin sensitisation (In vitro test system) - Details on study design:
according to guideline
Positive control results:
with the positive control cinnamaldehyde a dose dependent gene induction was observed.
Key result
Run / experiment:
other: 1 from 1 to 2000 µM
Parameter:
other: gene induction
Value:
0.7
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2 from 1 to 2000 µM
Parameter:
other: gene induction
Value:
0.8
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
detailed results on peptide depletion are provided in the table attached as background material
Interpretation of results:
other: the test substance was negative in this in vitro test
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a tiered approach three in chemico/in vitro tests were performed resulting in clear negative response in each test. In addition, the concentrated substance did not induce any skin reaction in the rabbit. It is therefore concluded that the substance does not have a skin sensitising potential and accordingly needs not to be classified.