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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-593-9 | CAS number: 123-03-5
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- other: Safety Evaluation US FDA
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Safety evaluation (Over-the-counter Drug Monograph) by an authoritative body, the US FDA.
Data source
Reference
- Reference Type:
- publication
- Title:
- Oral Health Care Drug Products for Over- the-Counter Human Use; Antigingivitis/ Antiplaque Drug Products; Establishment of a Monograph; Proposed Rules
- Author:
- Anonymous
- Year:
- 2 003
- Bibliographic source:
- Federal Register 68(103), May 29, 2003: 32232-32287
- Report date:
- 2003
Materials and methods
- Study type:
- other: Risk assessment document
- Endpoint addressed:
- other: overall clinical safety
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Overall clinical safety assessment
- GLP compliance:
- no
Test material
- Reference substance name:
- cetylpyridium chloride
- IUPAC Name:
- cetylpyridium chloride
- Reference substance name:
- Cetylpyridinium chloride
- EC Number:
- 204-593-9
- EC Name:
- Cetylpyridinium chloride
- Cas Number:
- 123-03-5
- Molecular formula:
- C21H38N.Cl
- IUPAC Name:
- cetylpyridinium chloride
- Reference substance name:
- CPC
- IUPAC Name:
- CPC
- Test material form:
- not specified
Constituent 1
Constituent 2
Constituent 3
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Remarks:
- population survey
Results and discussion
- Results:
- CPC is safe when used at concentrations of 0.045% to 0.1% in mouthrinse formulations.
Applicant's summary and conclusion
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.
