Pigment and Dyes Group - information sheet

Overview

The Government of Canada conducted a science-based evaluation, called a screening assessment of the Pigments and Dyes Group, to address the potential for harm to Canadians and to the environment.
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 extent of exposure there is to people or 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 Approach.
Substances in the Pigments and Dyes Group may be associated with human health and/or ecological effects; however, the risk to Canadians is low at current levels of exposure. It is proposed that these substances are not harmful to human health or to the environment at current levels of exposure.

This screening assessment focuses on 6 of 25 substances referred to collectively as the Pigments and Dyes Group. The 6 substances addressed in this screening assessment are D&C Orange 5, Pigment Violet 1, Acid Black 2, Pigment Red 81, CAS RN 26694-69-9, and Basic Red 29.
These substances were assessed as part of the third phase of the Chemicals Management Plan (CMP).
The 19 other substances in the Pigments and Dyes Group were determined to be of low concern to both human health and the environment, through other approaches. Conclusions for these CAS RNs 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 Government gathers information on substances, including details on their commercial status in Canada, to support risk assessment and risk management of substances under the CMP.
The 6 substances in the Pigments and Dyes Group do not occur naturally in the environment.
In Canada, these substances are used as colouring agents in products available to consumers, including cosmetics, food packaging materials, inks, textiles, and children’s arts and crafts materials.

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 information considered under the Ecological Risk Classification of organic substances, 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 (ability 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 Ecological Risk Classification of organic substances, D&C Orange and Pigment Red 81 were identified as having a low ecological hazard potential, while Pigment Violet 1, Acid Black 2, CAS RN 26694-69-9 and Basic Red 29 were identified as having a high ecological hazard potential, based on their moderate level of ecotoxicity.

Based upon a comparison of levels to which Canadians can be exposed to these substances and levels associated with health effects, along with the information presented in this screening assessment, it was 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 considered to be low.
Based on the outcome of the ecological risk classification of organic substances approach, these 6 substances are considered unlikely to cause ecological harm.
The Government of Canada published the Draft Screening Assessment for the Pigments and Dyes Group on January 5, 2019. This publication has a 60-day public comment period ending on March 6, 2019.

As a result of this assessment, the Government is proposing 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 current levels of exposure.
The Government is also proposing that these substances are not entering the environment at levels that are harmful to the environment.

These substances may be found in certain products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
Canadians who may be exposed to these substances in the workplace can 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).