Phenacetin - information sheet

Acetamide, N-(4-ethoxyphenyl)-
CAS Registry Number 62-44-2

Updated July 22, 2020:
The final screening assessment for phenacetin was published on July 28, 2018 under the Chemicals Management Plan (CMP). The assessment is summarized in this information sheet and has not changed. The section in this information sheet entitled "Preventive actions and reducing risk" communicates updates in risk management activities, namely:

• Application of the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA 1999) to phenacetin.

On this page

• Overview
• About this substance
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and reducing risk
• Related information

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 phenacetin.
• 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 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 (ERC) of Organic Substances Approach.
• The Government concluded that phenacetin is not harmful to human health or the environment at levels of exposure considered in the assessment. Although phenacetin may have potential health effects of concern, it was determined that the risk to Canadians is low.

About this substance

• The screening assessment focused on the substance acetamide, N-(4-ethoxyphenyl)-, also referred to as phenacetin. This substance was assessed under the third phase of the CMP.
• According to information gathered by the Government, phenacetin is mainly used as a laboratory reagent in research activities. It is also used in a small number of hair dye preparations where it functions as a stabilizer for hydrogen peroxide.
• In Canada, phenacetin is considered a prescription drug as per the Prescription Drug List. However, there were no marketed prescription drug products containing phenacetin in Canada, at the time of the assessment.

Human and ecological exposures

• Exposure of Canadians to phenacetin from environmental sources (for example, air, water, soil or food) is not expected.
• Dermal exposure to the scalp may occur during the use of hair dye products containing phenacetin.
• According to information considered under the ERC Approach, phenacetin was identified as having a low ecological exposure potential.

Key health and ecological effects (hazard)

• Phenacetin has been reviewed by the International Agency for Research on Cancer (IARC). This review was used to inform the health effects characterization in the screening assessment. Phenacetin is classified by IARC as carcinogenic to humans.
• Carcinogenicity (potential to cause cancer), as well as effects to the kidneys and blood cells, were the critical effects identified for characterizing the risk to human health in the screening assessment.
• According to information considered under the ERC Approach, phenacetin was identified as having a low ecological hazard potential.

Risk assessment outcomes

• Based upon a comparison of levels to which Canadians can be exposed to phenacetin, and levels associated with health effects, it was determined that the risk to human health from this substance is low.
• Based upon the outcome of the ERC Approach, this substance is considered unlikely to be causing ecological harm.
• The Government published the Final Screening Assessment for Phenacetin on July 28, 2018.

Screening assessment conclusions

• The Government concluded that phenacetin is not harmful to human health at levels of exposure considered in the assessment, and that it is not entering the environment at levels that are harmful to the environment.

Preventive actions and reducing risks

• Although phenacetin is not considered to be harmful to human health at levels of exposure considered in the assessment, this substance is considered to have a health effect of concern due to its potential to cause cancer. Therefore, there may be a concern if exposures were to increase.
• As a result, the Government of Canada published an order amending the Domestic Substances List (DSL) to apply the SNAc provisions of CEPA 1999 to phenacetin on July 22, 2020.
• This requires that the Government be notified of certain proposed new activities related to phenacetin, and that the new activity be assessed for potential risks to human health and the environment before being undertaken.
• The order outlines the definition of a significant new activity in relation to phenacetin, as well as the information that needs to be provided to the Government for assessment before the new activity is undertaken.

Related information

• Phenacetin may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
• Phenacetin is on the Prescription Drug List and all Canadian companies must hold a drug establishment license to manufacture, package, label, distribute, import, wholesale, or test this drug. Health Canada will continue to monitor the safety, efficacy and quality of substances containing phenacetin, which are regulated under the Food and Drugs Act and its regulations, and will take enforcement action as necessary in cases of non-compliance. For more information, you may review the Compliance and Enforcement Policy (POL-0001) and the Importing and exporting health products for commercial use (GUI-0117).
• 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.