Sodium cyclamate and cyclohexylamine - information sheet

Sulfamic acid, cyclohexyl-, monosodium salt
(sodium cyclamate)
CAS Registry Number 139-05-9

Cyclohexanamine
(cyclohexylamine)
CAS Registry Number 108-91-8

Overview

The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from sodium cyclamate and cyclohexylamine.
Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
- More information on assessing risk can be found in the Overview of Risk Assessment and related fact sheets, particularly on Types of Risk Assessment Documents and the Risk Assessment Toolbox.
The ecological hazard and exposure potentials of these substances were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
These substances are considered to have health effects of concern, based upon their potential reproductive effects; however, the risks to Canadians are considered to be low at levels of exposure considered in the assessment. As a result of the draft screening assessment, the Government is proposing that these substances are not harmful to human health or to the environment at levels of exposure considered in the assessment.

The screening assessment focuses on the substances sulfamic acid, cyclohexyl-, monosodium salt, and cyclohexanamine, also referred to as sodium cyclamate and cyclohexylamine, respectively. They were assessed under the Chemicals Management Plan (CMP).
Cyclohexylamine was moved from the Aliphatic Amines Group to the assessment of sodium cyclamate, since cyclohexylamine is a metabolite of sodium cyclamate in mammals and cyclohexylamine data informs the human health effects characterization of both substances.
According to information gathered by the Government, these substances do not occur naturally in the environment.
In Canada, sodium cyclamate is primarily used as a table-top sweetener, and as a non-medicinal ingredient in natural health products and drugs.
Cyclohexylamine is used in water treatment systems to prevent corrosion, and in boiler water systems to remove build up. It may also be used in cosmetics, as a formulant in pesticides, food packaging materials, incidental additives used in food premises (such as food processing facilities), and in other products available to consumers.

Canadians may be exposed to sodium cyclamate and cyclohexylamine from environmental sources (for example, drinking water) and through the use of certain products available to consumers, such as calcium and vitamin D supplements, mouthwash, chest congestion relief syrup, aerosol hairsprays, and gel fuel canisters for fireplaces and lanterns.
Canadians may also be exposed to these substances through their diet, from:
- the use of sodium cyclamate as a table-top sweetener
- the use of cyclohexylamine as a boiler water additive in food processing facilities.
According to information considered under the ERC Approach, sodium cyclamate and cyclohexylamine were identified as having low ecological exposure potential.

To inform the health effects characterization in this assessment, international reports of data on these substances were considered, including reviews by the Joint Food and Agriculture Organization of the United Nations/ World Health Organization Expert Committee on Food Additives, the International Agency for Research on Cancer and the European Scientific Committee on Food.
The European Commission has classified cyclohexylamine as a reproductive toxicant.
There were limited health effects (hazard) data for sodium cyclamate; therefore, a comparative approach using data for a similar chemical, called read-across, was used for assessing potential health effects.
For sodium cyclamate and cyclohexylamine, the critical effects identified for characterizing the risk to human health are potential effects on the testes.
According to information considered under the ERC Approach, sodium cyclamate and cyclohexylamine were identified as having low ecological hazard potential.

Based upon a comparison of levels to which Canadians may be exposed to sodium cyclamate and cyclohexylamine, and the levels associated with health effects, the risk to human health from these substances is considered to be low at levels of exposure considered in the assessment.
Based upon the outcome of the ERC Approach, these substances are considered unlikely to be causing ecological harm.
The Government of Canada published the Draft Screening Assessment for Sodium Cyclamate and Cyclohexylamine on December 14, 2019. The public are invited to comment on the assessment during the 60-day public comment period ending on February 12, 2020.

As a result of the draft screening assessment, the Government is proposing that sodium cyclamate and cyclohexylamine are not harmful to human health or the environment at levels of exposure considered in the assessment.

Although sodium cyclamate and cyclohexylamine are not considered to be harmful to human health at levels of exposure considered in the assessment, these substances are considered to have a health effect of concern based on their potential to cause reproductive effects. Therefore, there may be a potential risk for human health if exposure to these substances were to increase.
For this reason, follow-up activities to track changes in exposure and/or commercial use patterns for these substances are being considered.
Stakeholders are encouraged to provide any information pertaining to these substances that may help inform the choice of follow-up activity, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance.

Sodium cyclamate and cyclohexylamine may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
Sodium cyclamate should be used only on the advice of a physician when used as a table-top sweetener.
Health Canada's Guidelines for Incidental Additive Submissionsspecifies a concentration limit for using cyclohexylamine as an additive in boiler water systems in food processing facilities.
Canadians who may be exposed to these substances in the workplace should consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).