Coumarin 1 - Information sheet

2H-1-Benzopyran-2-one, 7-(diethylamino)-4-methyl-
CAS Registry Number 91-44-1

Publications summarized:

• Final Screening Assessment for 2H-1-benzopyran-2-one, 7-(diethylamino)-4-methyl- (coumarin 1) (published on May 13, 2023). Public comments received on the draft screening assessment and risk management scope were considered and a summary of the comments with Government responses was published.
• Risk Management Approach for 2H-1-Benzopyran-2-one, 7-(diethylamino)-4-methyl- (Coumarin 1) (published on May 13, 2023 for a 60-day consultation period). Risk management was proposed.
• Associated notice: Canada Gazette, Part I: Vol. 157, No. 19 – May 13, 2023

On this page

• Overview
• About this substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Consideration of subpopulations who may be more susceptible or highly exposed
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and risk reduction
  • Where to find updates on risk management actions
• Related resources

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment.
  • 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 ecological hazard and exposure potentials of this substance were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• The Government concluded that coumarin 1 is harmful to human health when used in certain cosmetic products (specifically specialty body makeup and temporary gel hair dye). Coumarin 1 may be associated with developmental effects.
• Risk management actions are proposed to help reduce exposures to coumarin 1 from certain cosmetics.
• The Government also concluded that coumarin 1 is not harmful to the environment at levels of exposure considered in the assessment.

About this substance

• The screening assessment focused on the substance 2H-1-benzopyran-2-one, 7-(diethylamino)-4-methyl-, also referred to as coumarin 1, under the third phase of the Chemicals Management Plan (CMP).
• According to information gathered by the Government, in Canada this substance is commercially applied to fabric, textile and leather articles, and used in certain cosmetic products, such as temporary hair dyes, nail polishes, and body, lip and facial makeup (including eye makeup). Coumarin 1 is also used as a stabilizer in a carpet cleaner and as a fragrance ingredient in cleaning products (for example multi-purpose cleaners).

Human and ecological exposures

• The screening assessment indicated that Canadians may be exposed to coumarin 1 in drinking water, from the use of cosmetic products, as well as cleaning products.
• According to the information considered under the ERC Approach, coumarin 1 was identified as having low ecological exposure potential.

Key health and ecological effects (hazard)

• There were limited health effects (hazard) data for coumarin 1; therefore, a comparative (read-across) approach using data from a similar chemical was used for assessing potential health effects.
• The critical effect identified for characterizing the risk to human health for coumarin 1 was developmental toxicity.
• According to information considered under the ERC Approach, coumarin 1 was identified as having a low ecological hazard potential.

Consideration of subpopulations who may be more susceptible or highly exposed

• There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
• Certain subpopulations are routinely considered throughout the screening assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated, and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. For coumarin 1, these subpopulations were taken into account in the risk assessment outcomes.

Risk assessment outcomes

• Based upon a comparison of levels to which Canadians may be exposed to coumarin 1 from occasional use of specialty body makeup (for example, body paint) and temporary gel hair dye, and levels associated with critical health effects, it was determined that this substance may pose a risk to human health.
• Based upon the outcome of the ERC Approach, coumarin 1 is considered unlikely to be causing ecological harm.

Screening assessment conclusions

• The Government concluded that coumarin 1 is harmful to human health at levels of exposure considered in the assessment.
• The Government also concluded that coumarin 1 is not entering the environment at levels that are harmful.
• Coumarin 1 meets 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 coumarin 1 to Schedule 1 of 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 options and continue discussion about their development.
• The risk management approach indicated that the Government is considering the following actions to address human health concerns:
  • Measures to reduce dermal (skin) exposure of the Canadian population to coumarin 1 from specialty body makeup and temporary gel hair dye, by describing this substance as a prohibited or restricted ingredient on the Health Canada 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 information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management approach, including where to send information during the public comment period, ending June 7, 2023.
• 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.

Where to find updates on risk management actions

• Updates on actions can be found on the timeline for coumarin 1. Up-to-date information on the Cosmetic Ingredient Hotlist is available. Additional information on the risk management of substances addressed under the CMP is available.
• 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

• Coumarin 1 is found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly, according to municipal or local guidelines.
• Cosmetic products must include a list of all ingredients on the product label using the International Nomenclature of Cosmetic Ingredients (INCI) system. Coumarin 1 is an INCI name.
• Visit Do it for a Healthy Home for information on chemical safety in and around the home, including on coumarin 1 (for consumers).
• The screening assessment focused on potential risks from exposure of the general population of Canada. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer or the Occupational Health and Safety Regulator in their jurisdiction.