Chlorhexidine and its salts – information sheet

What are they?

How are they used?

  • These substances are primarily found as antiseptics and antimicrobial preservatives in products such as prescription and non-prescription drugs for human or veterinary uses, hard-surface disinfectants, skin disinfectants, natural health products, and cosmetics.
  •  Based on the most recent survey data, none of these 4 substances were reported to be manufactured in Canada, whereas the chlorhexidine salts were reported to be imported into Canada.

Why is the Government of Canada assessing them?

  • Chlorhexidine and its salts were identified as priorities for assessment through the categorization of substances on the Domestic Substances List (DSL), or were considered a priority based on other concerns.
  • They are being assessed under the Chemicals Management Plan (CMP) for potential risks to the environment and to human health.
  • A draft screening assessment for 1 of these substances, chlorhexidine diacetate, was published in July 2013 as part of Batch 12 of the earlier Challenge Initiative of the CMP (then referred to as chlorhexidine acetate). At that time, this substance was proposed not to be harmful to human health, but harmful to the environment. However, to consider exposure from all potential sources of the chlorhexidine moiety, the draft screening assessment has been updated to address a broader group of substances, namely chlorhexidine and its salts.

How are Canadians exposed to them?

  • Exposure of the general population to these substances is expected to be low from environmental media, but can occur through the use of products containing these substances, such as cosmetics, natural health products and non-prescription drugs.

How are they released into the environment?

  • Release to the environment may result from the manufacture of chlorhexidine-based products.
  • Use of products containing these substances by consumers may also result in the release of these substances to wastewater systems.

What are the results of the assessment?

  • The Government of Canada conducted a science-based evaluation of chlorhexidine and its salts, called a screening assessment.
  • Screening assessments address the potential for harm to the general population of Canada and to the environment.
  • Results of the updated draft screening assessment indicate that although the chlorhexidine moiety is not expected to accumulate in organisms, it has the potential to remain in the environment for a long time.
  • As a result, the Government of Canada is proposing that chlorhexidine and its salts are entering or may enter the environment at levels that constitute a danger to the environment.
  • However, the government is proposing that chlorhexidine and its salts are not harmful to human health at current levels of exposure.

What is the Government of Canada doing?

What can Canadians do?

  • The health risks associated with a substance depend on its hazard (its potential to cause health effects) and the amount of substance to which a person is exposed.
  • As a general precaution, Canadians are reminded when using any product, to carefully follow safety warnings and directions and to dispose of the products appropriately.
  • Canadians who may be exposed to the chlorhexidine moiety in the workplace should consult with their employer and occupational health and safety (OHS) representatives about safe handling practices, applicable laws and requirements under the OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).
The chlorhexidine and its salts assessment includes, but is not limited to, these 4 substances
CAS RN DSL name Common name
55-56-1 2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino- Chlorhexidine
56-95-1 2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, diacetate Chlorhexidine diacetate
3697-42-5 2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, dihydrochloride Chlorhexidine dihydrochloride
18472-51-0 D-Gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide Chlorhexidine digluconate
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