The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
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, at levels of exposure considered in the assessment, the risk to human health is low.
Pigment Blue 61 and Brilliant Blue FCF are not harmful to human health or the environment.
The screening assessment focused on 6 of 7 substances, referred to collectively as the Triarylmethanes Group under the third phase of the Chemicals Management Plan (CMP). The substances are Basic Violet 3, Malachite Green, Pigment Blue 61, Basic Violet 4, Basic Blue 7, and Brilliant Blue FCF.
The other substance in this 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 in Canada as colouring agents: as dyes 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
The screening assessment indicated that people living in Canada may be exposed to the 5 dye substances in this group (Basic Violet 3, Malachite Green, basic Violet 4, Basic Blue 7, and Brilliant Blue FCF) from the use of products available to consumers, and from the environment (for example, drinking water). Exposure to Pigment Blue 61 is not expected for people living in Canada.
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.
The human health risks of CAS RN 632-99-5 (Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-2-methyl-, monohydrochloride) was characterized through the Rapid Screening of Substances with Limited General Population Exposure approach. On the basis of this approach, it was determined that exposure of the general population to this substance is considered negligible.
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.
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 limited health effects (hazard) data 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 similar substance, developmental effects were identified as the critical effect for characterizing the risk to human health from Malachite Green exposure.
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 people living in Canada 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 low for Pigment Blue 61 as human exposures are not expected.
It was determined that Malachite Green may pose a risk to human health from the use of hair dye, based upon the comparison of levels to which people living in Canada may be exposed to this substance and levels associated with critical health effects.
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 or 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.
Screening assessment conclusions
The Government concluded that Malachite Green may be harmful to human health at levels of exposure considered in the assessment. It 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.
Also, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 meet the persistence, but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
Preventive actions and risk reduction
The Government will consider adding Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7 to Schedule 1 to 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.
Publication of the risk management approach aims to inform stakeholders of proposed risk management actions and continue discussions about their development. The Government is considering the following actions to address human health concerns for Malachite Green:
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.
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.
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.
Information about SNAc provisions applied to substances, including new notices and orders, and those already published, can be found in the SNAc publications dataset.
Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.
Related resources
Some substances in the Triarylmethanes Group may be found in products available to consumers. People living in Canada 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 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.
