Aromatic 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
  • Additional considerations
• Related information

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 8 of the substances referred to collectively as the Aromatic Amines Group.
• 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.
• As a result of the draft screening assessment, the Government is proposing that, at levels of exposure considered in the assessment:
  • One substance (dimethylaniline) may be harmful to human health but not to the environment.
  • The other 7 substances in the Aromatic Amines Group are not harmful to human health or to the environment.
• Although 3 of the substances (NDPhA, 2-aminophenol, and MBOCA) are not considered to be harmful at levels of exposure considered in the assessment, these substances have health effects of concern and there may be a potential risk if exposure to these substances were to increase.

About these substances

• The screening assessment summarized here focuses on 8 substances, referred to collectively as the Aromatic Amines Group under the Chemicals Management Plan (CMP). These substances are commonly referred to as NDPhA, P1NA, 2-aminophenol, MBOCA, 44PD, dimethylaniline, diphenylamine, and 2-naphthyl anthranilate.
  • A Draft State of the Science Report for a screening health assessment of MBOCA was published on the Health Canada website in 2005.
  • MBOCA was also included in the Aromatic Amines subgroup of the Aromatic Azo and Benzidine-based substance grouping under the CMP; however, it was moved to the Aromatic Amines Group to better align with other international assessment activities on the substance.
• An additional 7 substances were initially identified in the Aromatic Amines Group, but these were determined to be of low concern to both human health and the environment through other approaches. Conclusions for these 7 substances are provided in the Screening Assessment for Substances Identified as Being of Low Concern using the Ecological Risk Classification of Organic Substances and the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances and the Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
• The 8 substances in this assessment do not occur naturally in the environment, except for diphenylamine, which may occur naturally in some food items (such as onions, cheese, and tea).
• According to information gathered by the Government, in Canada these substances are used in various applications, including adhesives and sealants, lubricants and greases, munitions, and plastic and rubber materials.
• They are also used in applications in the automotive, aircraft and transportation sector.
• They may also be used in incidental additives, and in food packaging materials, hair dye, and pest control products.

Human and ecological exposures

• Canadians may be exposed to substances in the Aromatic Amines Group mainly from the use of products available to consumers, such as grease and lubricants (for example, motor oils and transmission fluids), certain automotive products (for example, adhesives, automotive body fillers and spray paint primer), hair dyes, children's markers, and textiles (such as clothing).
• Canadians may also be exposed to these substances from the environment (for example, air), food, and from use in pest control products.
• According to information considered under the ERC Approach, P1NA was identified as having a high ecological exposure potential due to its overall persistence and large annual import quantity according to information reported. The remaining substances in the group were identified as having low to moderate ecological exposure potential.

Key health and ecological effects (hazard)

• To identify health effects information, international and national reports of data were considered. This includes assessments by the Organisation for Economic Cooperation and Development (OECD), the International Agency for Research on Cancer, the United States Environmental Protection Agency, the European Food Safety Authority, the Joint FAO/WHO Expert Committee on Food Additives, and the Pest Management Regulatory Agency, among others.
  • The United States Environmental Protection Agency classified NDPhA as a probable human carcinogen. Developmental effects were also identified as a critical effect in the assessment. The target organ of concern for both cancer and non-cancer effects is the bladder.
  • The critical effects identified for P1NA are effects on the blood system, the kidney, spleen and liver.
  • In the European Union (EU), 2-aminophenol is classified as a mutagen. Additional critical health effects identified include effects on the kidney, liver, as well as decreased body weights and increased thyroid weights.
  • The International Agency for Research on Cancer classified MBOCA as a carcinogen. Effects on the liver were also identified as a critical effect.
  • The critical effects identified for 44PD are effects on the liver and red blood cells.
  • Dimethylaniline has been classified in the EU as a suspected human carcinogen. Other critical effects identified are effects on the spleen and red blood cells.
  • The critical health effects identified for diphenylamine are effects on the red blood cells, kidneys, spleen and liver.
  • 2-Naphthyl anthranilate was considered to be of low hazard potential for the human health assessment.
• According to information considered under the ERC Approach, 2-aminophenol and MBOCA were identified as having a high ecological hazard potential based on their high potency and possible endocrine receptor binding, respectively. While 44PD, diphenylamine, and P1NA were identified as having a moderate ecological hazard potential based on adverse effects in aquatic food webs given their bioaccumulation potential. The remaining substances were identified as having a low ecological hazard potential.

Risk assessment outcomes

• Based upon a comparison of levels to which Canadians may be exposed to substances, and levels associated with critical health effects, it was determined in the draft screening assessment that:
  • dimethylaniline may pose a risk to human health from exposure to certain automotive products available to consumers; and
  • the risk to human health from NDPhA, P1NA, 2-aminophenol, MBOCA, 44PD, and diphenylamine is considered to be low.
• Using the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances, 2-naphthyl anthranilate is considered to be a low concern for human health at current levels of exposure.
• Based upon the outcome of the ERC Approach, these 8 substances are considered unlikely to be causing ecological harm
• The Government of Canada published the Draft Screening Assessment for the Aromatic Amines Group on August 15, 2020. The public is invited to comment on this assessment during the 60-day public comment period ending on October 14, 2020.

Proposed screening assessment conclusions

• As a result of the draft screening assessment, the Government is proposing that dimethylaniline may be harmful to human health, at levels of exposure considered in the assessment. It is also proposed that the other 7 substances are not harmful to human health at levels of exposure considered in the assessment.
• The Government is also proposing that the substances in the Aromatic Amines Group are not entering the environment at levels that are harmful to the environment.
• Also, dimethylaniline is proposed to meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.

Preventive actions and reducing risk

• The Government of Canada published Risk Management Scope for Aromatic Amines Group, specifically: Benzenamine, N,N-dimethyl- (dimethylaniline) on August 15, 2020. The public is invited to comment on this document during the 60-day public comment period ending on October 14, 2020.
• If the proposed conclusion is confirmed in the final screening assessment, the Government will consider adding benzenamine, N,N-dimethyl- to Schedule 1 of CEPA 1999, also called the List of Toxic Substances, and will consider the following actions to address health concerns:
  • Regulatory and/or non-regulatory measures to help reduce dermal and inhalation exposures to dimethylaniline contained in certain automotive products such as adhesives, sealants, fillers, primers, and bonding agent, available to consumers in Canada for do-it-yourself projects.
• Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management scope, including where to send information during the public comment period, ending October 14, 2020.
• 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.

Additional considerations

• Although NDPhA, 2-aminophenol and MBOCA are not considered to be harmful at levels of exposure considered in the assessment, these substances have health effects of concern based on their potential carcinogenicity or mutagenicity. Therefore, there may be a potential risk if exposure to these substances were to increase.
• For this reason, follow-up activities to track changes in exposure or commercial use patterns for NDPhA and 2-aminophenol are being considered.
• An analysis of information related to current and potential future uses of MBOCA suggest that it is unlikely that exposure will increase to levels of concern to human health. For this reason, follow-up activities to track changes in exposure and/or commercial use patterns for MBOCA are not being considered at this time.
• 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 substances.

Related information

• Substances in the Aromatic Amines Group 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.
• 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.