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EC number: 255-464-9 | CAS number: 41621-49-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Human data on a product containing 0.77% of ciclopirox olamine confirms that this substance at this concentration is not sensitizing. No data are available in literature about neat substance. Ciclopirox olamine is an organic salt; the assessment of sensitizing potential was focused on its dissociation products.
6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as skin sensitizer, according to the available QSAR data , but this prediction is little reliable.
2-aminoethanol (MEA) , the neutral form of ethanolminium cation, is not sensitizing in animals. However, available information about MEA in humans is ambiguous as there are negative but also several reports of dermatitis and positive epicutaneous test reactions to MEA.
Concern about Ciclopirox olamine sensitizing potential exists, therefore, from a worst case point of view, the substance is classified as Skin Sens.1, H317 according to Regulation (EC) n. 1272/2008 (CLP)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Principles of method if other than guideline:
- Data published on sensitizing potential for 2-aminoethanol, neutral form of ethanolaminium cation.
- GLP compliance:
- not specified
- Species:
- other: laboratory animals
- Reading:
- other: sensitizing potential
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-aminoethanol (MEA) , the neutral form of ethanolminium cation, is not sensitizing in animals. However, available information about MEA in humans is ambiguous as there are negative but also several reports of dermatitis and positive epicutaneous test reactions to MEA.
- Endpoint:
- skin sensitisation, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- see attached "Report CAS 29342-05-0"
- Principles of method if other than guideline:
- Derek Nexus; Toxtree; Vega (see atteched "Report CAS 29342-05-02)
- Conclusions:
- 6-cyclohexyl-4-methyl-2-oxopyridin-2(1H)-olate anion is considered as skin sensitizer, according to the available QSAR data.
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Principles of method if other than guideline:
- Human data on a product containing ciclopirox olamine
- Specific details on test material used for the study:
- Product containing 0.77% of ciclopirox olamine
- Species:
- other: Human data
- Reading:
- other:
- Parameter:
- other: sensitizing potential
- Remarks on result:
- other: not sensitizing
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Human data on a product containing 0.77% of ciclopirox olamine confirms that this substance at this concentration is not sensitizing (U.S. National Library of Medicine, Ciclopirox olamine cream).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.