Registration Dossier
Registration Dossier
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EC number: 200-238-7 | CAS number: 55-56-1
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987 / 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The incidence of IgE and IgG antibodies to chlorhexidine
- Author:
- Layton GT, Stanworth DR & Amos HE
- Year:
- 1 989
- Bibliographic source:
- Clin Experimen Allergy 19, 307–314
- Reference Type:
- publication
- Title:
- The specificity of murine polyclonal and monoclonal antibodies to the haptenic drug chlorhexidine induced by chlorine-generated chlorhexidine-protein conjugates
- Author:
- Layton GT, Stanworth DR & Amos E
- Year:
- 1 987
- Bibliographic source:
- Clin exp Immunol 69, 157-165
Materials and methods
- Study type:
- other: immunological study
Test material
- Reference substance name:
- Chlorhexidine
- EC Number:
- 200-238-7
- EC Name:
- Chlorhexidine
- Cas Number:
- 55-56-1
- Molecular formula:
- C22H30Cl2N10
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)]
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
The authors investigated the incidence of IgE and IgG antibodies to chlorhexidine by radio-allergosorbent technique (RAST) for IgE and enzyme linked immunosorbent assay (ELISA) for IgG and IgE using semi-chlorhexidine human serum albumin conjugates for both assays. Serum samples from Japanese patients having suffered from anaphylactic reactions and chlorhexidine exposed hospital staff from Japan and Great Britain as well as non-exposed patients were tested.
IgE antibodies to chlorhexidine were only detected in Japanese individuals with anaphylactic-type reactions to chlorhexidine, not in the other Japanese groups and not in the British hospital staff. In contrast, IgG antibodies to chlorhexidine were detected in sera of Japanese nurses and British hospital staff with regular contact to chlorhexidine.
The authors concluded that there was no evidence to suggest that the presence of serum IgG antibodies has any clinical relevance whatsoever and that further studies are needed for the determination of fine specificity of human IgE and IgG antibodies.
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