Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
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
- 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
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Qualifier:
- according to guideline
- Guideline:
- other: Direct peptide reactivity Assay (DPRA) for Skin Sensitization Testing, DB-ALM protocol n°154, January 12, 2013
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- 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
- 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
- Guideline:
- other: Human Cell Line Activation Test (h-CLAT) for Skin Sensitisation, DB-ALM Protocol n°158, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of dendritic cells
- Run / experiment:
- other: first dose finding experiment
- Parameter:
- other:
- 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
- Run / experiment:
- other: the second dose
- Parameter:
- other:
- Remarks:
- µg/mL
- Value:
- 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
- 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
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: KeratinoSens™, EURL ECVAM DB-ALM Protocol No. 155, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Run / experiment:
- other: First experiment
- Parameter:
- other: luciferase activity induction
- 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
- Run / experiment:
- other: second experiment
- Parameter:
- other: EC1.5
- Remarks:
- (uM)
- Value:
- 1 000
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- 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.
Referenceopen allclose all
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.
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
