Profile for the Phthalate substance grouping

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This document describes the considerations for development of a grouping of substances for assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), and the rationale for considering them to be a priority. The composition of the grouping may change with additional information gathering. More information on categorization results for these substances is available.

Grouping Description

• This grouping consists of diesters of 1,2-benzenedicarboxylic acid, also known as ortho-phthalates.
• Fourteen substances are included in this grouping and are identified in the list of Substances included in the Phthalate Substance Grouping. The scope of this grouping may be expanded to inform a cumulative assessment approach if warranted.
• Within the phthalates group assessment, there are 3 potential sub-groups based on structure-activity (observed differences in developmental toxicity):
  • Low molecular weight (MW) (R-alkyl backbone of 3 or less carbon atoms (=C3).
  • Intermediate MW [R-alkyl backbone of 4 to 6 carbon atoms (C4 to C6)].
  • High MW (R-alkyl backbone of 7 or more carbon atoms (=C7), or a benzyl group).
• From an ecological perspective, the initial approach may be to view the substances as a single broad group, with subgroups based on properties such as P, B, octanol-water partitioning coefficient (log K_ow), emerging early on in the assessment process.

Selection Considerations

• Potential health effects of concern. Some phthalates have been identified as potentially associated with reproductive and developmental effects^{Footnote 1}.
• Potential ecological effects of concern for some phthalates^{Footnote 2}.
• Potential exposure of consumers and children. A survey conducted for phase 1 of the Domestic Substances List (DSL) Inventory Update identified that a subset of phthalates have a wide range of consumer applications including: adhesives and sealants, paints and coatings, plastic and rubber materials, and automotive parts, which could result in exposure to humans, including children.
• Potential to leverage/align with international activity. Phthalates have been identified both domestically and internationally as priorities for assessment. For example:
  • In 2008, the United States National Research Council published a key document, Phthalates and Cumulative Risk Assessment: The Tasks Ahead, making the case for cumulative assessment^{Footnote 3}.
  • In 2009, the United States Environmental Protection Agency (US EPA) released an Action Plan for phthalates which includes conducting an assessment of phthalates under the Integrated Risk Information System (IRIS) program. The Phthalates Action Plan was revised in 2012.
  • United States Consumer Product Safety Commission Chronic Hazard Advisory Panel will conduct a cumulative hazard assessment of phthalates^{Footnote 4}.
• Potential risk assessment and risk management efficiencies and effectiveness.
  • Assessing as a group allows for consideration of aggregate exposure and cumulative risk, where warranted, and may inform potential substitution and to avoid repeated product formulation changes over time.

Potential Sectoral Involvement Identified through Phase 1 of the DSL Inventory Update

Note that the list of potential uses or sectors involved may not be comprehensive if not all substances included in the grouping were included in Phase 1 of the DSL Inventory Update survey. The use and/or sectors listed may not apply to all substances included in the grouping.

• Plastic and rubber manufacturers
• Automotive manufacturing
• Chemical (except agricultural) wholesaler distributors
• Adhesive and sealants manufacturers
• Petroleum and Coal Product Manufacturing