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Description of key information

Three in chemico studies were performed according to OECD TG 442C, 442D and 442E. The data generated with each one of these methods alone may be not sufficient to conclude on the absence of skin sensitisation potential of chemicals. They should be considered in the context of integrated approach.

In the first study (OECD TG 442C) 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.

In the second study (OECD TG 442D) the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered as non sensitiser.

In the last study (OECD TG 442E) the data showed a strong shift of the fluorescence signal for the test item compared to the medium. Therefore, it was assumed, that the test item is a strong fluorescent test chemical emitting at the same wavelength as FITC and interferes with the flow cytometric detection.

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
Study period:
08/06/2017-22/06/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: the samples could not be measured
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.
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01/06/2017 - 27/07/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: OECD Guidelines for Testing of Chemicals, No. 442E: “In vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT)” adopted 29 July 2016
Qualifier:
according to
Guideline:
other: Human Cell Line Activation Test (h-CLAT) for Skin Sensitisation, DB-ALM Protocol n°158, July 1st, 2015
GLP compliance:
yes (incl. certificate)
Type of study:
activation of dendritic cells
Parameter:
other:
Run / experiment:
first dose finding experiment
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
not determinable
Remarks:
no signal for the test item could be detected
Parameter:
other:
Remarks:
µg/mL
Run / experiment:
the second dose
Value:
ca. 0.18
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: derived from one single run

The data showed a strong shift of the fluorescence signal for the test item compared to the medium. Therefore, it was assumed, that the test item is a strong fluorescent test chemical emitting at the same wavelength as FITC and interferes with the flow cytometric detection.

Interpretation of results:
study cannot be used for classification
Conclusions:
The test item is a strong fluorescent test chemical emitting at the same wavelength as FITC and interferes with the flow cytometric detection; therefore it can not correctly be evaluated using FITC conjugated antibodies.
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16/05/2017-28/07/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Qualifier:
according to
Guideline:
other: KeratinoSens™, EURL ECVAM DB-ALM Protocol No. 155, July 1st, 2015
GLP compliance:
yes (incl. certificate)
Type of study:
activation of keratinocytes
Parameter:
other: luciferase activity induction
Run / experiment:
First experiment
Value:
<= 1.5
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: no significant luciferase induction of > 1.5 was found
Parameter:
other: EC1.5
Remarks:
(uM)
Run / experiment:
second experiment
Value:
< 1 000
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid

No dose response for luciferase activity induction was observed for each individual run as well as for an overall luciferase activity induction.Under the condition of this study the test item is therefore considered as non sensitiser.

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered as non sensitiser.

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

According to the results of the 3 in vitro studies and according to Regulation (EC) n. 1272/2008, no classification for the sensitization endpoint is assigned to the substance.