Phenacetin - information sheet

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

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  • The Government of Canada conducted a science-based evaluation, called a screening assessment, of phenacetin 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 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.
  • The ecological hazard and exposure potentials of this substance were classified using the Ecological Risk Classification of Organic Substances Approach.
  • Although phenacetin may have potential health effects, it was determined that the risk to Canadians is low at current levels of exposure. Therefore, it is concluded that phenacetin is not harmful to human health or the environment.

About this substance

  • This screening assessment focuses on the substance acetamide, N-(4-ethoxyphenyl)-, also referred to as phenacetin.
  • This substance was assessed as part of the third phase of the Chemicals Management Plan (CMP).
  • 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.
  • In Canada, 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 are currently no marketed prescription drug products that contain phenacetin.
  • Phenacetin is also listed in a limited number of licensed homeopathic medicines.

Exposure of Canadians and the environment

  • Exposure of Canadians to phenacetin from air, water, soil or food is not expected.
  • Dermal exposure to the scalp may occur during the use of hair dye products containing phenacetin.
  • For the ecological assessment, 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 this screening assessment. Phenacetin is classified by IARC as carcinogenic to humans.
  • Effects to the kidneys and blood cells were also considered to be the important or "critical" effects used for characterizing the risk to human health in this screening assessment.
  • Phenacetin was identified as having a low ecological hazard potential.

Risk assessment outcomes

  • Based on a comparison of levels of phenacetin to which Canadians can be exposed and levels associated with health effects, the risk to human health from this substance is considered to be low.
  • The Ecological Risk Classification of Organic Substances Approach characterized this substance as posing a low risk of harm to the environment.
  • The Government of Canada published the Final Screening Assessment for Phenacetin on July 28, 2018.

Screening assessment conclusions

  • As a result of this assessment, the Government concluded that phenacetin is not harmful to human health at current levels of exposure.
  • The Government also concluded that phenacetin 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 current levels of exposure, this substance is considered to have a health effect of concern due to its potential to cause cancer. Therefore, there may be a concern for human health if exposures were to increase.
  • The Government of Canada has published a notice of intent to apply the Significant New Activity (SNAc) provisions of CEPA 1999 to phenacetin. This publication has a 60-day public comment period ending on September 26, 2018.
  • The SNAc is proposed to target consumer products to which the Canada Consumer Product Safety Act applies, and cosmetics to which the Food and Drugs Act applies. This would require that the Government be notified of any proposed new activities related to phenacetin. New activity would be subject to assessment prior to the new activity commencing.

Important to know

  • Phenacetin can be found in certain products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
  • Phenacetin is listed in 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 Guidance Document on Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084).
  • Canadians who may be exposed to this substance in the workplace should 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).
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