Calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate - information sheet

hexanoic acid, 2-ethyl-, calcium salt
(calcium 2-ethylhexanoate)
CAS Registry Number 136-51-6

hexanoic acid, 2-ethyl-, 2-ethylhexyl ester
(2-ethylhexyl 2-ethylhexanoate)
CAS Registry Number 7425-14-1

Publications summarized:

• Final Screening Assessment for Calcium 2-Ethylhexanoate and 2-Ethylhexyl 2-ethylhexanoate (published on December 15, 2018)
• Risk management actions were taken.
• Associated notice: Canada Gazette, Part I: Vol. 152, No. 50 – December 15, 2018

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and risk reduction
  • Where to find updates on risk management actions
• 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 both by 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 potentials of these 2 substances were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• Although calcium 2-ethylhexanoate may be associated with health effects, the Government concluded that this substance is not harmful to human health or to the environment at levels of exposure considered in the assessment.
• The Government also concluded that 2-ethylhexyl 2-ethylhexanoate is harmful to human health, but not to the environment, at levels of exposure considered in the assessment. This substance may be associated with effects on human health. Risk management actions were taken on 2-ethylhexyl 2-ethylhexanoate to address human health concerns.

About these substances

• The screening assessment focused on the substances hexanoic acid, 2-ethyl-, calcium salt and hexanoic acid, 2-ethyl-, 2-ethylhexyl ester, also referred to as calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate, respectively. They were assessed under the third phase of the Chemicals Management Plan (CMP).
• These substances break down to 2-ethylhexanoic acid (2-EHA), a substance that was previously assessed by the Government under the Challenge initiative and was concluded to be not harmful to human health or to the environment.
• According to information gathered by the Government:
  • Calcium 2-ethylhexanoate was mainly used as an additive in interior and exterior paints and it may also be used as a component in the manufacture of some food packaging materials; however, exposure from food is expected to be negligible.
  • 2-Ethylhexyl 2-ethylhexanoate was used as an ingredient in cosmetics, and it may occur naturally in very low concentrations in a limited number of foods; however, the exposure from foods is expected to be negligible.

Human and ecological exposures

• The screening assessment indicated that Canadians may be exposed to calcium 2-ethylhexanoate through the use of indoor and outdoor household paints, and to 2-ethylhexyl 2-ethylhexanoate through the use of certain cosmetics, including foot lotion and face make-up.
• According to the information considered under the ERC Approach, these substances were identified as having a low ecological exposure potential.

Key health and ecological effects (hazard)

• There were limited health effects (hazard) data for calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects.
• Using data available for a similar substance (2-EHA; a breakdown product), the critical effects identified for characterizing the risk to human health for calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate were liver and developmental effects.
• According to information considered under the ERC Approach, these substances were identified as having a low ecological hazard potential.According to information considered under the ERC Approach, these substances were identified as having a low ecological hazard potential.

Risk assessment outcomes

• Risk assessment outcomes are based upon a comparison of levels to which Canadians may be exposed to these substances and levels associated with critical health effects.
  • It was determined that the risk to human health from calcium 2-ethylhexanoate is considered to be low.
  • It was also determined that 2-ethylhexyl-2-ethylhexanoate may pose a risk to human health.
• Based upon the outcome of the ERC Approach, calcium 2-ethylhexanoate and 2-ethylhexyl 2-ethylhexanoate are considered unlikely to be causing ecological harm.

Screening assessment conclusions

Calcium 2-ethylhexanoate

• The Government concluded that calcium 2-ethylhexanoate is not harmful to human health at levels of exposure considered in the assessment.
• The Government also concluded that calcium 2-ethylhexanoate is not entering the environment at levels that are harmful.

2-Ethylhexyl 2-ethylhexanoate

• The Government concluded that 2-ethylhexyl 2-ethylhexanoate is harmful to human health at levels of exposure considered in the assessment.
• The Government also concluded that 2-ethylhexyl 2-ethylhexanoate is not entering the environment at levels that are harmful.
• It was also determined that 2-ethylhexyl 2-ethylhexanoate meets the bioaccumulation criteria, but not the persistence criteria, as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.

Preventive actions and risk reduction

Calcium 2-ethylhexanoate

• Although calcium 2-ethylhexanoate was 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 based on its potential developmental effects. There may be a concern if exposure levels were to increase.
• Therefore, the Government of Canada published an order amending the Domestic Substances List (DSL) to apply the SNAc provisions of CEPA 1999 to calcium 2-ethylhexanoate on August 17, 2022.
• The SNAc provisions require that the Government be notified of certain proposed new activities related to calcium 2-ethylhexanoate, 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 the substance, as well as the information that needs to be provided to the Government for assessment before the new activity is undertaken.

2-Ethylhexyl 2-ethylhexanoate

• On March 2, 2019, the proposed order adding 2-ethylhexyl-2-ethylhexanoate to Schedule 1 of CEPA 1999, also called the List of Toxic Substances, was published. Adding a substance to the list does not restrict its use, manufacture or import. Rather, it enables the Government to take risk management actions under CEPA 1999.
• The Risk Management Approach for 2-Ethylhexyl 2-ethylhexanoate was published in December 2018 for public comment. The following actions were taken to address human health concerns:
  • On October 14, 2020, 2-Ethylhexyl-2-ethylhexanoate was proposed as a restricted ingredient on Health Canada's Cosmetic Ingredient Hotlist. The public was invited to comment on the proposal during the 60-day public comment period ending on December 12, 2020. The Hotlist is used to communicate that certain substances may not be compliant with requirements of theFood and Drugs Act or the Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
  • On September 12, 2020, the Government of Canada published a notice of intent to apply the SNAc provisions of CEPA 1999 to 2-ethylhexyl 2-ethylhexanoate. The public was invited to comment on the notice of intent during the 60-day public comment period ending on November 11, 2020.

Where to find updates on risk management actions

• Updates on actions can be found on the timeline for these 2 substances. Up-to-date information on the Cosmetic Ingredient Hotlist is available.
• Also, information on SNAc provisions applied to substances is 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

• Calcium 2-ethylhexanoate and 2-ethylhexyl-2-ethylhexanoate may be found in certain products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
• Cosmetic products must include a list of all ingredients on the product label using the International Nomenclature of Cosmetic Ingredients (INCI). 2-Ethylhexyl 2-ethylhexanoate would be identified under the INCI name: Ethylhexyl Ethylhexanoate.
• 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 (WHMIS). 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.