Sodium ortho-phenylphenate - information sheet

[1,1'-Biphenyl]-2-ol, sodium salt (SOPP)
CAS Registry Number 132-27-4

Publications summarized:

• Final Screening Assessment for [1,1'-Biphenyl]-2-ol, sodium salt (Sodium ortho-phenylphenate; SOPP) (Published on November 19, 2022). Public comments received on the draft screening assessment were considered and a summary of the comments with Government responses was published.
• Associated notice: Canada Gazette, Part I: Vol. 156, No. 47 – November 19, 2022

On this page

• Overview
• About this substance
• 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
• 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 and 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 potential of SOPP was classified using the Ecological Risk Classification of Organic Substances (ERC) Approach .
• The Government concluded that SOPP is not harmful to human health or to the environment at levels of exposure considered in the assessment.
• Although SOPP has effects of concern for human health, it was determined that the risk to Canadians posed by this substance is low at current levels of exposure.

About this substance

• The screening assessment focused on the substance [1,1'-biphenyl]-2-ol, sodium salt, also referred to as sodium ortho-phenylphenate (SOPP). It was assessed under the third phase of the Chemicals Management Plan (CMP).
• SOPP does not occur naturally in the environment. According to information gathered by the Government, this substance is used as a material preservative agent. In Canada, SOPP is used in building or construction materials, in products available to consumers (such as cosmetics [bar soap], and tire and rubber lubricants). SOPP may also be used as a component in the manufacture of food packaging materials, in incidental additives used in food processing establishments or as a medicinal ingredient in disinfectants.
• SOPP is also an active ingredient and formulant in registered pest control products in Canada. In 2008, it was reviewed by Health Canada's Pest Management Regulatory Agency (PMRA) and the re-evaluation for 2-Phenylphenol and Salts is available upon request. The next re-evaluation of 2-phenylphenol (OPP) and its salts (including SOPP) will be initiated in 2024-2025. Additional information on the re-evaluation is available in the PMRA re-evaluation and special review work plan.

Human and ecological exposures

• The main source of exposure for Canadians to SOPP from products available to consumers is from bar soap and tire and rubber lubricants. Exposures may also occur from food and its use in food packaging materials.
• According to information considered under the ERC Approach, SOPP was identified as having a low ecological exposure potential.

Key health and ecological effects (hazard)

• To inform the health effects characterization in the screening assessment, national and international data reports on SOPP were considered, including reviews by Health Canada's PMRA, the United States Environmental Protection Agency , and the International Agency for Research on Cancer (IARC), among others.
• The IARC classified SOPP as "possibly carcinogenic to humans".
• A comparative approach using a similar chemical, called read-across, was used to inform the human health assessment.
• Critical effects considered in the screening assessment of SOPP were decreased weight gain and kidney effects based on laboratory studies. Other effects noted at higher doses were bladder tumours.
• According to information considered under the ERC Approach, SOPP 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 SOPP, 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 SOPP, and levels associated with health effects, it was determined that there is low risk of harm to human health from SOPP.
• Based upon the outcome of the ERC Approach, SOPP is considered unlikely to be causing ecological harm.

Screening assessment conclusions

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

Preventive actions and risk reduction

• Although SOPP is not considered to be harmful at current levels of exposure, this substance is considered to have health effects of concern (potential to cause cancer). Therefore, there may be a potential risk if exposure to SOPP were to increase.
• For this reason, the Government intends to apply the Significant New Activity (SNAc) provisions of CEPA 1999 to SOPP.
• The SNAc provisions would require that the Government be notified of certain proposed new activities related to the substance, and that the new activity be assessed before being undertaken.

Where to find updates

• The timeline for SOPP is updated to reflect new or changed activities. Also, information about SNAc provisions applied to substances, including new notices and orders, and those already published, can be found in the SNAc publications dataset.
• 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

• SOPP 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, according to municipal or local guidelines.
• 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.