Registration Dossier
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Diss Factsheets
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EC number: 204-593-9 | CAS number: 123-03-5
- 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
Evaluated by authoritative bodies as safe for use as recommended in consumer cosmetic/oral care formulations and as a residue in human food products.
Additional information
CPC is used in the consumer products market in cosmetics and in the food industry as a disinfectant in preparation of poultry products. The SCCS, FDA and EFSA have reviewed the data on this substance and have undertaken risk assessments for these applications. EFSA concluded that there are no safety concerns for humans from the proposed use of the product (Cecure®) for removal of microbial surface contamination from poultry under the usage conditions specified in this opinion. The data on which this conclusion is based was judged to be satisfactory for selection of a NOAEL as a point of departure for a margin of safety assessment.
Similarly, risk assessments have been undertaken by the SCCS and the U.S. FDA for oral care products for consumers. The safety of cetylpyridinium chloride has been extensively evaluated in a variety of controlled, clinical and nonclinical studies. The SCCS concluded that there are no safety concerns for humans from the proposed use of CPC in selected cosmetic products under the usage conditions specified in this opinion. This is based on the same NOAEL in animal studies as that used by EFSA. Similarly, the FDA reviewed submitted safety information, in addition to adverse event data collected during more than 55 years of U.S. marketing of mouthrinses containing cetylpyridinium chloride, and the FDA Subcommittee concludes that cetylpyridinium chloride is safe when used at concentrations of 0.045% to 0.1% in mouthrinse formulations.
The evaluations by these authoritative bodies support the conclusions of this risk assessment.
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.