Chlorhexidine

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

Reference

Reference 1

Reference Type:

publication

Title:

The incidence of IgE and IgG antibodies to chlorhexidine

Author:

Layton GT, Stanworth DR & Amos HE

Year:

1989

Bibliographic source:

Clin Experimen Allergy 19, 307–314

Reference 2

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:

1987

Bibliographic source:

Clin exp Immunol 69, 157-165

Materials and methods

Study type:

other: immunological study

Test material

Test material information

Constituent 1

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)]

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.