Hexamethylenetetramines Group - information sheet

3,5,7-Triaza-1-azoniatricyclo[3.3.1.1³,7] decane, 1-(3-chloro-2-propenyl)-, chloride (cis/trans-CTAC)
CAS Registry Number 4080-31-3

3,5,7-Triaza-1-azoniatricyclo[3.3.1.1³,7] decane, 1-(3-chloro-2-propenyl)-, chloride, (Z)- (cis-CTAC)
CAS Registry Number 51229-78-8

1,3,5,7-Tetraazatricyclo[3.3.1.1³,7] decane, hydrochloride (Methenamine hydrochloride)
CAS Registry Number 58713-21-6

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • Proposed screening assessment conclusions
• Preventive actions and reducing risk
• Related information

Overview

• The Government of Canada conducted a science-based screening assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to address the potential for harm to the general population and to the environment from the 3 substances in the Hexamethylenetetramines Group.
• 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.
• As a result of the draft screening assessment, Cis/trans-CTAC and cis-CTAC, also referred to as Quaternium-15, are proposed to be harmful to human health from potential exposures of concern to infants, toddlers, and children from body moisturizers and sunscreen lotions.
  • Cis/trans-CTAC and cis-CTAC are not proposed to be harmful to the environment.
  • Cis/trans-CTAC and cis-CTAC may have effects on the testes and liver, as well as developmental effects.
• Methenamine hydrochloride is not proposed to be harmful to human health or to the environment.
• The Government of Canada is considering revising the listing for Quaternium-15 in the Natural Health Products Ingredients Database (NHPID) to reduce exposures of Canadian infants, toddlers, and children to Quaternium-15 in topical products such as body moisturizer and sunscreen lotion.

About these substances

• The screening assessment summarized here focuses on 3 substances, referred to collectively as the Hexamethylenetetramines Group, under the Chemicals Management Plan (CMP). These substances are cis/trans-CTAC, cis-CTAC, and methenamine hydrochloride.
• For the human health assessment, cis/trans-CTAC and cis-CTAC were assessed together as they are both associated with the common International Nomenclature of Cosmetics Ingredients name "Quaternium-15".
• According to information gathered by the Government, cis/trans-CTAC and cis-CTAC are used in the automotive, aircraft, and transportation sectors, as well as in automotive care products, and paints and coatings. Consumer uses include cleaning products, paints, adhesives, and self-care products (i.e., cosmetics, and as a non-medicinal ingredient in non-prescription drugs and natural health products).
• Cis/trans-CTAC is also a medicinal ingredient in drug products, and may be used in food packaging materials and in surface cleaners and hand cleaners used in food processing establishments.
• Cis-CTAC may be used as a component in hand cleaners and lubricants used in food processing establishments.
• Methenamine hydrochloride is an impurity in products available to consumers containing cis/trans-CTAC.
• All substances in the Hexamethylenetetramines Group have been identified as formulants in registered pest control products in Canada, with cis/trans-CTAC also identified as an active ingredient in pest control products.

Human and ecological exposures

• Canadians may be exposed to cis/trans-CTAC, cis-CTAC, and methenamine hydrochloride from environmental sources (for example, drinking water), and from their use in products available to consumers, as described above. Exposure may occur through dermal contact (through the skin) and incidental oral ingestion (by mouth).
• According to the information considered under the ERC Approach, cis-CTAC and methenamine hydrochloride were identified as having low ecological exposure potential. Cis/trans-CTAC, however, was classified as having a moderate ecological exposure potential based on its persistence and annual import quantity.

Key health and ecological effects (hazard)

• To inform the health effects characterization in the draft screening assessment, international and national reports of data and toxicological studies were considered.
• The critical effects identified to characterize the risk to human health for substances in the Hexamethylenetetramines Group are as follows:
  • For cis/trans-CTAC and cis-CTAC, effects on the testes and liver were identified to be the critical effects associated with the dermal route of exposure. General toxicity (that is, reduced body weight and food consumption) and developmental effects were identified to be the critical effects associated with the oral route of exposure.
  • Cis-CTAC is harmful if swallowed, suspected of damaging the unborn child, causes skin irritation, and may cause an allergic reaction according to the harmonized classification and labelling approved by the European Union.
  • There were limited health effects (hazard) data for methenamine hydrochloride; therefore, a comparative approach (called read-across) using a similar chemical was used for assessing potential health effects.
• According to information considered under the ERC Approach, all 3 substances in the Hexamethylenetetramines Group were identified as having a low ecological hazard potential.

Risk assessment outcomes

• It was determined that cis/trans-CTAC and cis-CTAC may pose a risk to human health for younger subpopulations (that is, infants, toddlers, and children) from dermal exposure through their use in non-prescription sunscreen lotion and natural health product body moisturizers. This was based upon a comparison of levels to which Canadians may be exposed to these 2 substances and levels associated with critical effects.
• It was also determined that there is a low risk of harm to human health from methenamine hydrochloride, based on a comparison of levels to which Canadians may be exposed to this substance, and the levels associated with critical health effects.
• Based upon the outcome of the ERC Approach, the 3 substances are considered unlikely to be causing ecological harm.
• The Government of Canada published the Draft Screening Assessment for the Hexamethylenetetramines Group on March 6, 2021. The public is invited to comment on the assessment during the 60-day public comment period ending on May 5, 2021.

Proposed screening assessment conclusions

• The Government is proposing that cis/trans-CTAC and cis-CTAC may be harmful to human health at levels of exposure considered in the assessment. It is also proposing that methenamine hydrochloride is not harmful to human health at levels of exposure considered in the assessment.
• The Government is proposing that cis/trans-CTAC, cis-CTAC, and methenamine hydrochloride are not entering the environment at concentrations that may be harmful to the environment.
• It is proposed that cis/trans-CTAC and cis-CTAC do not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.

Preventive actions and reducing risk

• The Government of Canada published the Risk Management Scope for Certain Substances in the Hexamethylenetetramines Group on March 6, 2021. The public is invited to comment on this document during the 60-day public comment period ending on May 5, 2021.
• If the proposed conclusion is confirmed in the final screening assessment, the Government will consider adding cis/trans-CTAC and cis-CTAC to Schedule 1 of CEPA 1999, also called the List of Toxic Substances. Adding a substance to the list does not restrict its use, manufacture or import. Rather, it enables the Government to take risk management actions under CEPA 1999.
• The Government will also consider the following actions to address human health concerns:
  • Cis/trans-CTAC and cis-CTAC are both identified by the name Quaternium-15 in products for consumers, such as natural health products. The action being considered is revising the listing for Quaternium-15 in the Natural Health Products Ingredients Database (NHPID) to reduce exposures of Canadian infants, toddlers, and children to cis/trans-CTAC and cis-CTAC in topical products (body moisturizer and sunscreen lotion).
• Risk management actions may evolve through consideration of assessments and risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
• Further information and updates on risk management actions for substances managed under the CMP can be found in the risk management actions table and the two year rolling risk management activities and consultations schedule.

Related information

• The substances in the Hexamethylenetetramines Group are found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
• The screening assessment focused on potential risks from exposure of the general population of Canada, rather than occupational exposure. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety, Canadians should consult their employer for information on what steps to take in the workplace and/or the Occupational Health and Safety Regulator in their jurisdiction.