Registration Dossier

Toxicological information

Health surveillance data

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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:
2003
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
not specified

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