Under 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.
As a result of the screening assessment, Solvent Violet 13 is concluded to be harmful to human health. The remaining 6 substances included in the assessment are not considered harmful to human health at levels of exposure considered in the assessment. The substances in this group do not pose a risk to the environment at levels of exposure considered in the assessment.
About these substances
The screening assessment summarized here focused on 7 of 15 substances referred to collectively as the Anthraquinones Group, under the Chemicals Management Plan (CMP). The substances addressed in the screening assessment are Solvent Violet 13, Pigment Blue 60, Solvent Violet 59, Solvent Blue 36, Disperse Red 60, Acid Blue 239 and CAS RN 74499-36-8.
These substances do not occur naturally in the environment.
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, arts and crafts materials, toys, do-it-yourself products and textiles.
Human and ecological exposures
Canadians may be exposed to these substances from the use of products available to consumers, such as body creams, lipsticks/lip balms, make-up, face paint, hair products, craft stampers and toys.
Some of these substances may be used in certain food packaging materials in Canada; however, exposure from food is negligible.
According to information considered under the Ecological Risk Classification of Organic Substances approach, these 7 substances were identified as having a low ecological exposure potential.
Key health and ecological effects (hazard)
There were limitations to the health effects data available for some of these substances; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects.
The substances included in the assessment, except for Pigment Blue 60, are considered to be possibly carcinogenic (able to cause cancer). This was considered to be one of the critical effects used for characterizing the risk to human health for these substances.
Solvent Blue 36 may also cause developmental effects.
According to information considered under the Ecological Risk Classification of Organic Substances approach, these substances were identified as having a high ecological hazard potential based on their high level of ecotoxicity and potential to accumulate in aquatic and terrestrial organisms.
Risk assessment outcomes
Exposure of the general population to Solvent Violet 59, Solvent Blue 36, Disperse Red 60, Acid Blue 239, and CAS RN 74499-36-8 at current levels are not of concern. The risk to human health from Pigment Blue 60 is considered to be low given the information presented in the screening assessment.
Based upon a comparison of the levels to which Canadians may be exposed to Solvent Violet 13, and levels associated with health effects, it was determined that this substance may pose a risk to human health.
Based upon the outcome of the Ecological Risk Classification of Organic Substances approach, these substances are considered unlikely to be causing ecological harm.
As a result of the assessment, the Government concluded that Pigment Blue 60, Solvent Violet 59, Solvent Blue 36, Disperse Red 60, Acid Blue 239 and CAS RN 74499-36-8 are not harmful to human health at levels of exposure considered in the assessment.
However, the Government concluded that Solvent Violet 13 may be harmful to human health at levels of exposure considered in the assessment.
Solvent Violet 13 meets the persistence criteria, but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
The Government also concluded that the 7 substances are not entering the environment at levels that are harmful to the environment.
The Government will consider measures to reduce consumer exposure to Solvent Violet 13 from the use of certain cosmetics.
The Government is proposing to add Solvent Violet 13 to 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.
Additional considerations
Although a risk to human health or the environment has not been identified at current levels of exposure, there may be a concern if exposure to Solvent Violet 59, Solvent Blue 36, Disperse Red 60, Acid Blue 239, and CAS RN 74499-36-8 were to increase. As a result, these substances may be considered in future initiatives to track their commercial status or identify new uses.
Related information
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.
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.
