Sodium ortho-phenylphenate (SOPP) - information sheet

[1,1’-Biphenyl]-2-ol, sodium salt
CAS Registry Number 132-27-4

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 sodium ortho-phenylphenate (SOPP).
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 and 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 potential of this substance was classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
As a result of the draft screening assessment, the Government is proposing 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.

The draft screening assessment focuses on the substance [1,1’-biphenyl]-2-ol, sodium salt, also referred to as SOPP. It was assessed under 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 and in products available to consumers, such as tire and rubber lubricants. It may also be used as a component in food packaging materials and as a non-medicinal ingredient in natural health products and non-prescription drugs.
SOPP is also registered as an active ingredient and is a formulant in registered pest control products in Canada. Health Canada's Pest Management Regulatory Agency (PMRA) final re-evaluation decision for 2-Phenylphenol and Salts included a risk assessment and risk mitigation measures to protect human health and the environment from pesticidal uses of SOPP, under the authority of the Pest Control Products Act. Therefore, exposures to SOPP resulting from pesticidal sources and uses of SOPP are not characterized further in the screening assessment summarized here.

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

To inform the health effects characterization in the draft screening assessment, national and international reports of data 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.
The critical effects were decreased weight gain and kidney effects. 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.

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.
Also, based upon the outcome of the ERC Approach, SOPP is considered unlikely to be causing ecological harm.
The Government of Canada published the Draft Screening Assessment for Sodium ortho-phenylphenate (SOPP) on February 29, 2020. The public is invited to comment on this assessment during the 60-day public comment period ending on April 29, 2020.

The Government is proposing 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 to the environment.

Although SOPP is not considered to be harmful to human health at current levels of exposure, this substance is considered to have health effects of concern. There may be a concern if exposure to SOPP was to increase.
For this reason, follow-up activities to track any future changes in exposure are being considered.
Stakeholders are encouraged to provide information on SOPP that may help inform the choice of follow-up activity, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance.

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.
Canadians who may be exposed to SOPP 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.