Aliphatic Amines Group - information sheet

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 Canadians and to the environment from 13 substances in the Aliphatic Amines 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.
• The ecological hazard and exposure potentials of the 4 short-chain aliphatic amine substances in this Group were classified individually using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• The Government is proposing that long-chain aliphatic amine substances, including the 9 substances in this group, may be harmful to the environment at levels of exposure considered in the assessment, from the sectors of concern identified in the assessment and risk management scope. The long-chain aliphatic amine 1,3-propanediamine, N-[3-(tridecyloxy)propyl]-, branched (also referred to as DPDAB) may also be harmful to human health at levels of exposure considered in the assessment. None of the 4 short-chain aliphatic amine substances are proposed to be harmful to human health or to the environment.

About these substances

• The screening assessment summarized here focuses on 13 of 19 substances referred to collectively as the Aliphatic Amines Group under the Chemicals Management Plan (CMP). The 13 substances are organized into 2 subgroups based on carbon chain length: short-chain aliphatic amines (alkyl-chain <8 carbon atoms) and long-chain aliphatic amines (alkyl-chain ≥8 carbon atoms).
• The 4 short-chain aliphatic amines are dimethylbenzylamine, ethylenediamine, diethylenetriamine, and dimethylamine.
• The 9 long-chain aliphatic amines are hexadecyldimethylamine; octadecylamine; cocoamine; bis(hydrogenated tallow alkyl) amines (BHTAA); hydrogenated tallow alkyl amines acetates (HTAAA); tallow alkyl amines acetates (TAAA); N-tallow alkyltrimethylenediamines (TAPDA); 1,3-propanediamine, N-[3-(tridecyloxy)propyl]-, branched (DPDAB); and, N,N,N'-trimethyl-N'-tallow alkyltrimethylenediamines (TMTADA).
• For long-chain aliphatic amines, the ecological risk was assessed using a class-based approach. The approach considers the 9 substances in the group as well as all long-chain aliphatic amines that are captured within two subclasses (monoamines and diamines) as being part of the long-chain aliphatic amines class. These substances are cationic surfactants with similar reactivity and ecotoxicity, and they may co-occur in and impact the environment, collectively.
• For the human health assessment, substances in the Aliphatic Amines Group were assessed individually, as there were differences in the types of critical health effects observed.
• Four of the original 19 substances in this group were determined to be of low concern through other approaches. Conclusions for the substance with the CAS RN 68955-53-3 are provided in the Screening Assessment of Substances Identified as Being of Low Concern based on the Ecological Risk Classification of Organic Substances and the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances . Conclusions for the substances with the CAS RN 112-90-3, 80939-62-4, and 90367-27-4 are provided in the Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
• In addition, 2 of the 19 substances (CAS RNs 108-91-8 and 58713-21-6) were moved from the Aliphatic Amines Group into other assessment groups under the CMP, namely the Sodium Cyclamate and Cyclohexylamine Group and the Hexamethylenetetramines Group. 
• According to information gathered by the Government, major industrial uses of long-chain aliphatic amines include polyurethane foam production, formulation of cleaning products and personal care products, flotation in mineral extraction, and formulation of asphalt emulsions. Aliphatic amines are also used in the production of other chemicals. Five substances in the group (cocoamine, BHTAA, HTAAA, TAAA, and TAPDA) were manufactured in Canada.
• In Canada, aliphatic amines are used in a variety of products available to consumers, as well as commercial and industrial products. Consumer uses include automotive care, pest control, building and construction materials, cleaning and furnishing care, personal care (cosmetics, natural health products, and drugs), paints and coatings, among others.
• Dimethylamine occurs naturally in food. Some of these substances may be used as components in food packaging materials or in incidental additives used in food processing establishments. Ethylenediamine, dimethylamine, hexadecyldimethylamine, cocoamine, HTAAA, and TAPDA were identified as formulants in pest control products registered in Canada.

Human and ecological exposures

• Canadians may be exposed to the 4 short-chain aliphatic amines from the use of products available to consumers, food, or the environment (for example, air or drinking water).
• Exposure of Canadians to some of the long-chain aliphatic amines (hexadecyldimethylamine, octadecylamine, cocoamine, and BHTAA) can occur from their use in various products available to consumers, such as non-prescription drugs, cosmetics, natural health products, among other products. Exposure may also occur from the environment (for example, air or drinking water) or food.
• Canadians may be exposed to DPDAB from the use of certain two-component marine epoxy adhesive products.
• The human health risks of HTAAA, TAAA, TAPDA, and TMTADA were characterized using the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances. The exposure estimates generated for these long-chain aliphatic amines were lower than their assigned TTC values. Therefore, these substances are considered to be a low concern for human health at levels of exposure considered in the assessment.
• According to the information considered under the ERC Approach, the 4 short-chain aliphatic amines were identified as having low ecological exposure potential.

• Long-chain aliphatic amines may be released to the Canadian environment from the formulation, manufacture, and consumer use of products containing these substances, as well as from their uses in various industrial processes. Releases to aquatic and terrestrial environments are expected from both diffuse and point sources, for example, from wastewater treatment systems or directly from industrial sites.

Key health and ecological effects (hazard)

• Ethylenediamine and dimethylamine have been reviewed internationally through the Organisation for Economic Co-operation and Development (OECD) Cooperative Chemicals Assessment Programme. This information was used to inform the health effects characterization of these substances, where applicable.
• There were limited effects data for some of the substances in this Group; therefore, a comparative approach using similar chemicals, called read-across, was used to inform both the human health and ecological assessments.
• Critical effects identified to characterize risk to human health for substances in this Group are as follows:
  • For dimethylbenzylamine and dimethylamine, general toxicity, such as reduced body weight, reduced food consumption and salivation.
  • For ethylenediamine, effects on the liver, kidneys, lungs, adrenal glands, and blood chemistry.
  • Reproductive/developmental effects for diethylenetriamine.
  • For the long-chain aliphatic amines, effects on certain lymph nodes, general toxicity, effects on the gastrointestinal tract, and/or inflammatory effects.
• According to information considered under the ERC Approach, the 4 short-chain aliphatic amines were identified as having a low ecological hazard potential.
• Studies have shown that long-chain aliphatic amines have the potential to cause adverse effects in aquatic, sediment, and soil-dwelling organisms at low concentrations.

Risk assessment outcomes

Human health risk assessment:

• For the 4 short-chain aliphatic amines, a comparison of levels at which Canadians may be exposed to these substances and levels associated with critical health effects found that the risk to human health from these substances is low. The risk to human health was also determined to be low for the long-chain aliphatic amines hexadecyldimethylamine, octadecylamine, cocoamine, and BHTAA.
• Based upon a comparison of levels to which Canadians may be exposed to DPDAB from the use of a two-component marine epoxy adhesive product, and levels associated with health effects, it was determined that this substance may pose a risk to human health.
• Using the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances, HTAAA, TAAA, TAPDA, and TMTADA are considered to be a low concern for human health.

Ecological risk assessment:

• Based upon the outcome of the ERC Approach, the 4 short-chain aliphatic amine substances are considered unlikely to be causing ecological harm.
• Considering all information presented in the draft screening assessment, it was determined that there may be risk of harm to the environment from long-chain aliphatic amines, including the 9 in this group. Specifically, exposures from long-chain aliphatic amine production and processing, production of polyurethane foam (polyol blend), iron ore extraction, formulation of asphalt emulsion, formulation of fertilizers, and down the drain release of cleaners and personal care products containing long-chain aliphatic amines may result in a risk of harm to the environment.
• The Government of Canada published the Draft Screening Assessment for the Aliphatic Amines 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 the long-chain aliphatic amine DPDAB may be harmful to human health at levels of exposure considered in the assessment. None of the other 12 substances in the Aliphatic Amines Group are proposed harmful to human health.
• The Government is also proposing that long-chain aliphatic amines, including the 9 in this group, may be entering the environment at levels that are harmful to the environment. It is also proposed that the 4 short-chain aliphatic amines are not harmful to the environment.
• It is proposed that long-chain aliphatic amines with C14 or greater alkyl-chains meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999, but those with alkyl chains less than C14 do not, and that long-chain aliphatic amines do not meet the persistence 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 Long-chain Aliphatic Amines (including DPDAB CAS RN 68479-04-9) 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 conclusions are confirmed in the final screening assessment, the Government will consider adding long-chain aliphatic amines 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. A non-exhaustive list of substances that meet the definition of long-chain aliphatic amines can be found in Annex B of the risk management scope.
• The Government will consider the following actions:
  • To address human health concerns from DPDAB, the Government is considering regulatory or non-regulatory measures to help reduce consumer exposure to DPDAB from certain adhesive products intended for consumer use, specifically a two-component marine epoxy.
  • The Government is also considering regulatory and non-regulatory instrument(s) to address environmental concerns related to long-chain aliphatic amines.
• Information is being sought by the Government to inform risk management decision-making. Details can be found in the proposed risk management scope, including where to send information during the public comment period, ending May 5, 2021.
• Information on the risk management of substances addressed under the CMP is available.

Related information

• Substances in the Aliphatic Amines Group may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the use and responsible disposal of the product.
• Visit Do it for a Healthy Home for more information on chemical safety in and around the home.
• 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 and what steps to take in the workplace, Canadians should consult their employer and/or the Occupational Health and Safety Regulator in their jurisdiction.