Pigment and Dyes Group - information sheet

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 6 substances in the Pigments and Dyes 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 screening assessment, the Government concluded that the 6 substances in the Pigments and Dyes Group are not harmful to human health or to the environment, at levels of exposure considered in the assessment. Although substances in this group may be associated with human health or ecological effects, the risk is considered to be low given the levels of exposure.

The screening assessment summarized here focuses on 6 of 25 substances referred to collectively as the Pigments and Dyes Group under the Chemicals Management Plan (CMP).
The 6 substances are D&C Orange 5, Pigment Violet 1, Acid Black 2, Pigment Red 81, CAS RN 26694-69-9, and Basic Red 29.
The other 19 substances were determined to be of low concern to both human health and the environment, through other approaches. Conclusions for these substances 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 and the Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
According to information gathered by the Government, these substances may be used in Canada as colouring agents in products available to consumers, including cosmetics, food packaging materials, inks, textiles, and children's arts and crafts materials.
The 6 substances in this Group do not occur naturally in the environment.

Canadians may be exposed to substances in the Pigments and Dyes Group through the use of products available to consumers, such as hair products, make-up, clothing, crayons and chalk.
Some of these substances may be used in certain food packaging materials in Canada; however, exposure to substances in this group from food is not expected.
According to the information considered under the ERC Approach, D&C Orange 5, Pigment Violet 1, Acid Black 2, Pigment Red 81, CAS RN 26694-69-9, and Basic Red 29 were identified as having low ecological exposure potential.

No effects of concern for human health have been identified for D&C Orange 5, Acid Black 2 and Basic Red 29.
Based upon data available on its dye component, Pigment Violet 1 is associated with adverse health effects, including carcinogenicity (potential to cause cancer).
Adverse health effects, including decreased body weight, were also identified for Pigment Red 81 and CAS RN 26694-69-9, based upon data available on their respective dye components.
According to information considered under the ERC Approach, D&C Orange and Pigment Red 81 were initially identified as having a low ecological hazard potential; however, these have been revised and are now identified as having high hazard potential due to their higher ecotoxicity and bioaccumulation potential. Pigment Violet 1, Acid Black 2, CAS RN 26694-69-9 and Basic Red 29 were also identified as having a high ecological hazard potential, based on their higher level of ecotoxicity and bioaccumulation potential.

A comparison of levels to which Canadians may be exposed to these substances and levels associated with health effects, along with the information presented in this screening assessment, determined that the risk to human health from D&C Orange 5, Pigment Violet 1, Acid Black 2, Pigment Red 81, CAS RN 26694-69-9, and Basic Red 29 is low.
Based upon the outcome of the ERC Approach, these 6 substances are considered unlikely to be causing ecological harm.
The Government of Canada published the Final Screening Assessment for the Pigments and Dyes Group on August 1, 2020.

The Government concluded that D&C Orange 5, Pigment Violet 1, Acid Black 2, Pigment Red 81, CAS RN 26694-69-9, and Basic Red 29 are not harmful to human health at levels of exposure considered in the assessment.
The Government also concluded that these substances are not entering the environment at levels that are harmful to the environment.

These substances 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.
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 and what steps to take in the workplace, Canadians should consult their employer and/or the Occupational Health and Safety Regulator in their jurisdiction.

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