Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 847-971-4 | CAS number: 2363126-59-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 442E
- Version / remarks:
- June 2018
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM: Human Cell Line Activation Test (h-CLAT)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Activation of immortalised human monocytic leukemia cell line, used as a surrogate for dendritic cells.
- Justification for non-LLNA method:
- The human Cell Line Activation Test (h-CLAT) has been evaluated in a European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM)-coordinated validation study and subsequent independent peer review by the EURL ECVAM Scientific Advisory Committee (ESAC) and has been recommended to be used as part of an integrated approach to testing and assessment (IATA) to support the discrimination between sensitisers and non-sensitisers for the purpose of hazard classification and labelling.
Test material
- Reference substance name:
- Manganese-(II)-hexacyanomanganate (II) sodium salts
- EC Number:
- 847-971-4
- Cas Number:
- 2363126-59-2
- Molecular formula:
- NaxMny[Mn(CN)6]z X = 1.2-1.4; Y = 1.0; Z = 0.8-0.85
- IUPAC Name:
- Manganese-(II)-hexacyanomanganate (II) sodium salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
- Specific details on test material used for the study:
- See section on test material
In vitro test system
- Details on the study design:
- Skin sensitisation (In vitro test system) - Details on study design:
Activation of monocytes and dendritic cells in the human monocytic leukemia cell line THP-1, by quantifying changes in the expression of cell surface markers (CD86 and CD54).
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Experiment 1
- Parameter:
- other: CD86
- Remarks:
- % of relative fluorescence intensity
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Run / experiment:
- other: Experiment 2
- Parameter:
- other: CD86
- Remarks:
- % of relative fluorescence intensity
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Run / experiment:
- other: experiment 1
- Parameter:
- other: CD54
- Remarks:
- % of relative fluorescence intensity
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Run / experiment:
- other: Experiment 2
- Parameter:
- other: CD54
- Remarks:
- % of relative fluorescence intensity
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Parameter:
- other: CD86: EC150
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- The EC150 value was not calculated for CD86 as viability was less than 50% at the concentration that gave an RFI value >150% in Experiment 2
- Key result
- Parameter:
- other: CD54: EC200
- Remarks:
- µg/mL
- Value:
- 36.48
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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.
