Triarylmethanes Group - information sheet

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • 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 substances in the Triarylmethanes 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.
• As a result of the screening assessment, the Government concluded that Malachite Green is harmful to human health at levels of exposure considered in the assessment. Also, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 are concluded to be harmful to the environment. Basic Violet 3, Basic Violet 4, and Basic Blue 7 are also associated with health effects of concern; however, the risk to human health is low, at levels of exposure considered in the assessment. Pigment Blue 61 and Brilliant Blue FCF are not harmful to human health or the environment.

About these substances

• The screening assessment focused on 6 of 7 substances referred to collectively under the Chemicals Management Plan (CMP) as the Triarylmethanes Group. The substances addressed in the screening assessment are Basic Violet 3, Malachite Green, Pigment Blue 61, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF.
• The other substance in the Triarylmethanes Group was determined to be of low concern to both human health and the environment through other approaches. Conclusions for the substance with CAS RN 632-99-5 (Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-2-methyl-, monohydrochloride) are provided in the Final Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
• Triarylmethanes do not occur naturally in the environment.
• According to information gathered by the Government, these substances are primarily used as colouring agents: as dyes and/or pigments in inks, toners and colourants, in paper products and manufactured items, and potentially in food packaging.
• Substances in this group may also be used in other products available to consumers, including cosmetics, cleaning products, and water treatment for aquarium fish. They are also used in industrial and laboratory products.
• Basic Violet 3 (also called Gentian Violet) was previously used as a medicinal ingredient in drugs for human and veterinary use. In June 2019, Health Canada conducted a safety review of human health products and veterinary drugs containing this substance and found that these exposures were a concern. As a result, Health Canada worked with manufacturers to remove all licensed drug products containing Gentian Violet from the market and the associated drug licenses have been cancelled.
• Brilliant Blue FCF is also used in food, natural health products, pest control products, prescription and non-prescription drugs, and a range of additional products available to consumers.

Human and ecological exposures

• For human health, the main sources of exposure to the 5 dye substances in this group (Basic Violet 3, Malachite Green, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF) are from the use of products available to consumers, as well as from the environment (for example, drinking water). Exposure to Pigment Blue 61 for the general population of Canada is not expected.
• Potential exposures to the 5 dye substances from drinking water were estimated. Exposures to Malachite Green, Basic Violet 4, and Basic Blue 7 were also derived from the use of cosmetics (hair dyes), while exposures to Brilliant Blue FCF were derived from the use of natural health products, cosmetics, as well as for dietary exposure from its use as a food additive. Inhalation exposure to Brilliant Blue FCF from the use of perfume was also characterized.
• All of these substances may be released to the Canadian environment as a result of their uses in Canada, including paper dyeing, de-inking of paper, as well as from the formulation, manufacture and consumer use of products containing these substances.
• The ecological assessment focused on exposures for down-the-drain releases from uses of products containing these substances, and for releases from industrial sites.
• Releases are possible to both the aquatic and terrestrial environments (water and land) and these dyes tend to persist in water, sediment, and soil.

Key health and ecological effects (hazard)

• To identify health effects information, international reports of data were considered. This included reviews through the Joint FAO/WHO Expert Committee on Food Additives and the United States National Toxicology Program, among others.
• Basic Violet 3 has been classified as a substance suspected of causing cancer, according to the harmonized classification and labelling approved by the European Union.
• There were some limitations to the health effects data available for Malachite Green; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects. Using data available for a related substance, developmental effects were identified as the critical effect for characterizing the risk to human health from exposure to Malachite Green.
• Carcinogenicity (potential to cause cancer) was the critical effect for characterizing the risk to human health from Basic Violet 4 and Basic Blue 7, using a read-across approach for these 2 substances.
• With respect to ecological effects, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 have the potential to cause effects to aquatic organisms at low concentrations.
• Brilliant Blue FCF may also cause effects in aquatic organisms at relatively high concentrations, according to experimental data. No ecological effects were observed for Pigment Blue 61.

Risk assessment outcomes

• Based upon a comparison of levels to which Canadians may be exposed to Basic Violet 3, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF, and levels associated with health effects, it was determined that the risk to human health from these 4 substances is low. The risk is also considered to be low for Pigment Blue 61 as human exposures are not expected.
• Similar comparisons of exposure to Malachite Green from hair dye, and levels associated with health effects, indicated that this substance may pose a risk to human health.
• In the ecological assessment, it was found that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 may pose a risk to aquatic organisms on the basis of exposure scenarios for paper dyeing and paper de-inking, but not for the scenarios for general formulation/product handling and consumer uses of products.
• Considering all information presented, it was determined that there is risk of harm to the environment from Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7. Pigment Blue 61 and Brilliant Blue FCF are not expected to pose a risk to the environment.
• The Government of Canada published the Final Screening Assessment for the Triarylmethanes Group on October 17, 2020.

Screening assessment conclusions

• As a result of the screening assessment, the Government concluded that Malachite Green may be harmful to human health at levels of exposure considered in the assessment. It was also concluded that the other 5 substances are not harmful to human health at levels of exposure considered in the assessment.
• The Government concluded that Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 are entering the environment at levels that may be harmful to the environment. It was also concluded that Pigment Blue 61 and Brilliant Blue FCF are not entering the environment at levels that are harmful to the environment.
• Also, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 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 published the Proposed Risk Management Approach for Certain Triarylmethanes (specifically, Basic Violet 3, Malachite Green, Basic Violet 4 and Basic Blue 7) on October 17, 2020. The public is invited to comment on this document during the 60-day public comment period ending on December 16, 2020.
• The proposed order adding Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 to Schedule 1 of CEPA 1999, also called the List of Toxic Substances, was published for a 60-day public comment period ending on June 1, 2022.
• To address human health concerns for Malachite Green, the Government is considering the following actions:
  • Communicating measures to reduce exposures to Malachite Green from certain cosmetics by describing it as a prohibited or restricted ingredient on Health Canada's Cosmetic Ingredient Hotlist. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or the Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
  • applying Significant New Activity (SNAc) provisions under CEPA 1999 to Malachite Green. The SNAc would require that any proposed new manufacture, import or use of certain products containing Malachite Green (for example, markers) be subject to further assessment and potential risk management.
• To address ecological concerns, the Government is considering an environmental release guideline to limit releases of Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 to water from pulp and paper facilities. An amendment to include these 4 substances in the Guidelines for the Reduction of Dyes Released from Pulp and Paper Mills may be proposed.
• Information is being sought by the Government to inform risk management decision-making. Details can be found in the proposed risk management approach, including where to send information during the public comment period, ending December 16, 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 Basic Violet 3, Basic Violet 4, and Basic Blue 7 are not considered to be harmful to human health at levels of exposure considered in the assessment, these substances are considered to have health effects of concern. There may be a potential risk if exposures were to increase.
• Therefore, follow-up activities to track changes in exposure are being considered. These may involve including the substances in future information gathering initiatives, such as a mandatory survey under section 71 of CEPA 1999, or the application of the Significant New Activity provisions of CEPA 1999.

Related information

• Some of these substances 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.
• In addition, some of these substances may be found in arts and crafts materials for children. Health Canada has provided general information on using arts and crafts materials safely.
• Visit Do it for a Healthy Home for information on chemical safety in and around the home.
• Cosmetic products must include a list of all ingredients on the product label using the International Nomenclature of Cosmetic Ingredients (INCI) system. Malachite Green would be identified under the INCI name Basic Green 4.
• 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. For information concerning workplace health and safety, Canadians should consult their employer and/or the Occupational Health and Safety Regulator in their jurisdiction for information on what steps to take in the workplace.