Triarylmethanes Group - information sheet

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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.
  • As a result of this screening assessment, Malachite Green is proposed to be harmful to human health at current levels of exposure. Also, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 are proposed to be harmful to the environment. Basic Violet 3, Basic Violet 4, and Basic Blue 7 are associated with health effects of concern; however, the risk to human health is low at current levels of exposure. Pigment Blue 61 and Brilliant Blue FCF are not proposed to be harmful to human health or the environment.

About these substances

  • This screening assessment focuses on 6 of 7 substances referred to collectively under the Chemicals Management Plan (CMP) as the Triarylmethanes Group. The substances addressed in this 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 CAS RN 632-99-5 are provided in the Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
    • Triarylmethanes do not occur naturally in the environment. They are primarily used as colouring agents: as dyes and/or pigments in inks, toners and colourants, in paper products, mixtures or manufactured items, and potentially in food packaging.
    • Substances in this group may be used in other products available to consumers, including children’s arts and crafts materials (for example, paint markers), cosmetics, cleaning products, and water treatment for aquarium fish. They are also used in industrial and laboratory products.
  • Basic Violet 3 is a medicinal ingredient in drugs for human and veterinary use. 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.

Exposure of Canadians and the environment

  • 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 oral and/or dermal exposures from drinking water and/or the use of various products available to consumers were estimated for the 5 dye substances. For Brilliant Blue FCF, potential inhalation exposures from the use of perfume, as well as dietary exposure from its use as a food additive, were 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 they tend to persist in water, sediment, and soil.

Key health and ecological effects (hazard)

  • 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 important or "critical" effect for characterizing the risk to human health from exposure to Malachite Green.
  • Carcinogenicity (potential ability 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.
  • 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 higher concentrations, according to experimental data. No 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 exposures are not expected.
  • Similar comparisons of exposure to Malachite Green and levels associated with health effects, however, 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 general formulation/product handling and consumer uses of products scenarios.
  • 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.
  • Also, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 are proposed to meet the persistence criteria, but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
  • The Government of Canada published the Draft Screening Assessment for the Triarylmethanes Group on December 8, 2018. This publication has a 60-day public comment period ending on February 6, 2019.

Proposed screening assessment conclusions

  • As a result of this screening assessment, the Government is proposing that Malachite Green may be harmful to human health at current levels of exposure. It is also proposed that the other 5 substances are not harmful to human health at current levels of exposure.
  • The Government is proposing 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 is also proposed that Pigment Blue 61 and Brilliant Blue FCF are not entering the environment at levels that are harmful to the environment.

Preventive actions and reducing risk

  • The Government published the proposed Risk Management Scope for Basic Violet 3, Malachite Green, Basic Violet 4 and Basic Blue 7 on December 8, 2018. This publication has a 60-day public comment period ending on February 6, 2019.
  • The Government intends to add 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.
  • If the proposed conclusion is confirmed in the final screening assessment, the Government is proposing the following risk management actions to address human health concerns for Malachite Green:
    • add Malachite Green to Health Canada’s Cosmetic Ingredient Hotlist
    • apply Significant New Activity provisions under CEPA 1999 to Malachite Green. The SNAc would require that the Government be notified of any proposed new activities related to Malachite Green, and that the new activity be assessed for potential risks to human health and/or the environment before being undertaken.  
    • further investigate the need for risk management of arts and crafts products containing Malachite Green, which may be used by children.  
  • The Government is also proposing the following risk management actions to address ecological concerns for Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 (non-sulfonated triarylmethanes):
    • work with stakeholders to further quantify sources of releases of non-sulfonated triarylmethanes to the environment throughout its lifecycle; and
    • develop regulatory or non-regulatory initiatives would limit releases of Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 from the pulp and paper sector to levels that would prevent or minimize the effects on the aquatic environment.
  • 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 February 6, 2019.
  • Although Basic Violet 3, Basic Violet 4, and Basic Blue 7 are not considered to be harmful to human health at current levels of exposure, these substances are considered to have health effects of concern. There may be a potential risk for human health if exposures were to increase.
  • Therefore, follow-up activities to track changes in exposures and/or commercial use patterns for these 3 substances (Basic Violet 3, Basic Violet 4, and Basic Blue 7) 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.
  • Further information and updates on risk management actions can be found in the CMP Risk Management Actions Table and the Two Year Rolling Risk Management Activities and Consultations Schedule.

Important to know

  • Some of these substances may be found in products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
  • 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 Healthy Home for more 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.
  • 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).
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