Chlorhexidine

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1986

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 Type:

publication

Title:

Antiseptic toxicity in wounds healing by secondary intention

Author:

Brennan SS, Foster ME & Leaper DJ

Year:

1986

Bibliographic source:

J Hosp Infect 8, 263-267

Materials and methods

Type of study / information:

Effects on chronic ulcer care and biochemical and histological parameters have been examined

Principles of method if other than guideline:

In 135 Sprague-Dawley female rats (90-110 g) the skin over the thoraco-lumbar spine was removed with hair clippers. Four 10 mm full thickness skin wounds were made approximately 1 cm apart in the shaved area.
Controls (N=45): Normal saline was applied to each wound using copolymer T-starch hydrogel as a vehicle.
Chlorhexidine (N=45): Aqueous 0.05 % chlorhexidine was applied in place of normal saline.
The vehicle used is able to absorb up to 130 % of its weight of fluid and is chemically inert. One gram of dry granules were saturated with 5 ml of saline or antiseptic agent, resulting in the formation of a thick paste. One mL of the paste was applied to each wound and all four wounds were then covered with a polyacrylamide dressing and an adhesive polyurethene film, which were kept in place with a secondary elastoplast dressing.
Rats were housed individually. On the third, fifth and seventh postoperative days, 15 rats from each group were killed and the granulation tissue, which constituted the healing wounds, was excised from two of the wounds of each animal and stored at -20°C prior to biochemical analysis. The two remaining wounds were excised with a rim of skin and placed in formol saline for histological analysis and oculometric analysis of re-epithelialisation. Granulation tissue from one wound was assayed for hydroxyproline content, as a measure of collagen synthesis, and from the other for deoxyribonucleic acid (DNA), as a measure of tissue cellularity.
The Mann-Whitney U Test has been used for statistical analysis.

Test material

Test material information

Constituent 1

Reference substance name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

EC Number:

242-354-0

EC Name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

Cas Number:

18472-51-0

IUPAC Name:

N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)

Applicant's summary and conclusion

Executive summary:

Compared to controls, no effect of chlorhexidine application to wounds were noted when the following parameters were assessed: collagen formation in granulation tissue as determied by hydroxyproline content, DNA-content of tissue in wounds, histological observation. Therefore, adverse effects concerning wound healing after application of chlorhexidine (used as antimicrobial agent) are not to be expected.