Risk management scope for Hexanoic acid, 2-ethyl-, 2-ethylhexyl ester (2-ethylhexyl-2-ethylhexanoate)

Chemical Abstracts Service Registry Number 7425-14-1

Environment and Climate Change Canada
Health Canada

March 2017

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Table of contents

Summary of proposed risk management

This document outlines the risk management options under consideration for the substance 2-ethylhexyl-2-ethylhexanoate. In particular, the Government of Canada is considering:

  1. adding 2-ethylhexyl-2-ethylhexanoate to the Health Canada Cosmetic Ingredient Hotlist;
  2. applying Significant New Activity provisions under CEPA to 2-ethylhexyl-2-ethylhexanoate.

The risk management options outlined in this Risk Management Scope document may evolve through consideration of assessments and risk management options published for other Chemicals Management Plan (CMP) substances as required to ensure effective, coordinated, and consistent risk management decision-making.

Note: The above summary is an abridged list of options under consideration to manage this substance and to seek information on identified information gaps and uncertainties. Refer to section 3 of this document for more complete details in this regard.

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1. Context

The Canadian Environmental Protection Act, 1999 (CEPA) (Canada 1999) provides the authority for the Minister of the Environment and the Minister of Health (the Ministers) to conduct assessments to determine if substances are toxic to the environment and/or harmful to human health as set out in section 64 of CEPAFootnote 1, Footnote2 and if so to manage the associated risks.

The substance hexanoic acid, 2-ethyl-, 2-ethylhexyl ester, Chemical Abstracts Service Registry Number (CAS RNFootnote 3) 7425-14-1, referred to throughout this document as “2-ethylhexyl-2-ethylhexanoate”, is included in the assessment of calcium 2-ethylhexanoate and 2-ethylhexyl-2-ethylhexanoate, as part of the CMP (Canada 2016).

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2. Issue

2.1 Draft screening assessment conclusion

Health Canada and Environment and Climate Change Canada conducted a joint screening assessment relevant to the evaluation of 2-ethylhexyl-2-ethylhexanoate and calcium 2-ethylhexanote (hexanoic acid, 2-ethyl-, calcium salt, CAS RN 136-51-6, referred to throughout this document as calcium 2-ethylhexanoate) in Canada. A notice summarizing the scientific considerations of the draft screening assessment for these substances was published in the Canada Gazette,Part I, on 25 mars 2017 (Canada 2017).

Based on the information available, the draft screening assessment proposes that 2-ethylhexyl-2-ethylhexanoate is harmful to human health under section 64(c) of CEPA because it is entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health (Canada 2016). It is proposed that calcium 2-ethylhexanoate is not harmful to human health under section 64(c) of CEPA because it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. However, calcium 2-ethylhexanoate has effects of concern based on potential developmental toxicity in laboratory animals. While available information does not indicate a risk to human health for Canadians at current levels of exposure, there may be a concern if exposures were to increase.

It is proposed that 2-ethylhexyl-2-ethylhexanoate and calcium 2-ethylhexanoate are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends under section 64(a) or 64(b) of CEPA, respectively (Canada 2016).

The exposure source of concern, identified in the draft screening assessment, is dermal exposure to 2-ethylhexyl-2-ethylhexanoate from foot lotion and face make-up (refer to section 5).

Of note, the proposed risk management options described in this document and the proposed conclusion outlined in the draft screening assessment are preliminary and may be subject to change. For further information refer to the draft screening assessment for 2-ethylhexyl-2-ethylhexanoate and calcium 2-ethylhexanoate.

2.2 Proposed recommendation under CEPA

Based on the findings of the draft screening assessment conducted as per CEPA, the Ministers propose to recommend that 2-ethylhexyl-2-ethylhexanoate be added to the List of Toxic Substances in Schedule 1 of the ActFootnote4.

The Ministers will take into consideration comments made by stakeholders during the 60-day public comment period on the draft screening assessment and Risk Management Scope document in the preparation of the final screening assessment and Risk Management Approach document, if required. If it is concluded that 2-ethylhexyl-2-ethylhexanoate meets one or more of the criteria under section 64 of CEPA at the time of the final screening assessment and the Ministers recommend the addition of 2-ethylhexyl-2-ethylhexanoate to Schedule 1, risk management instrument(s) will be proposed within 24 months of the date on which the final screening assessment is published and will be finalized within 18 months of the date on which the risk management instrument(s) are proposed.

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3. Proposed risk management

3.1 Proposed human health objective

Proposed human health objectives are quantitative or qualitative statements of what should be achieved to address human health concerns.

The proposed human health objective for 2-ethylhexyl-2-ethylhexanoate is to reduce exposure of the general population to the substance to levels that are protective of human health.

3.2 Proposed risk management objective and options under consideration

Proposed risk management objectives set quantitative or qualitative targets to be achieved by the implementation of risk management regulations, instrument(s) and/or tool(s) for a given substance or substances. In this case, the proposed risk management objectives for 2-ethylhexyl-2-ethylhexanoate are:

  1. to reduce dermal exposure to the sources of greatest concern, specifically cosmetics containing 2-ethylhexyl-2-ethylhexanoate; and
  2. to prevent increases in exposure to 2-ethylhexyl-2-ethylhexanoate.

To achieve the proposed risk management objectives and to work towards achieving the proposed human health objective, the risk management options under consideration are:

  1. Add 2-ethylhexyl-2-ethylhexanoate to Health Canada's Cosmetic Ingredient Hotlist, which is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances may contravene the general prohibition found in section 16 of the Food and Drugs Act (FDA) or may contravene one or more provisions of the Cosmetic Regulations. Section 16 of the FDA states that "No person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user". In addition, the hotlist includes certain substances that may make it unlikely for a product to be classified as a cosmetic under the FDA. Compliance with the provisions of section 16 are monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations of the Food and Drugs Act, which requires that all manufacturers and importers provide a list of the cosmetic's ingredients to Health Canada.
  2. Apply Significant New Activity provisions under CEPA to 2-ethylhexyl-2-ethylhexanoate that would require that any proposed new manufacture, import or use be subject to further assessment and that would determine if the new activity requires further risk management consideration.

Following the publication of this Risk Management Scope document, additional information obtained from the public comment period and from other sources will be considered, along with the information presented in this document, in the instrument selection and development processFootnote 5. The risk management options outlined in this document may evolve through consideration of assessments and risk management options published for other CMP substances to ensure effective, coordinated, and consistent risk management decision-making.

3.3 Risk management information gaps

At this time, no additional information is required from industry.

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4. Background

4.1 A general information on 2-Ethylhexyl-2-ethylhexanoate

2-Ethylhexyl-2-ethylhexanoate is an organic substance and is based on the parent structure 2-ethylhexanoic acid (2-EHA), CAS RN 149-57-5, which was evaluated by Health Canada and Environment and Climate Change Canada as part of the Challenge initiative (Health Canada 2011). 2-Ethylhexyl-2-ethylhexanoate is the ester of 2-EHA and 2-ethylhexanol.

4.2 Current uses and identified sectors

Responses to a 2011 survey indicated that there were no reports of manufacture or import of 2-ethylhexyl-2-ethylhexanoate in Canada above the reporting threshold of 100 kg in that year (Environment Canada 2013).

According to notifications submitted under the Cosmetic Regulations to Health Canada (Canada 2016), 2-ethylhexyl-2-ethylhexanoate is used in certain cosmetic products in Canada, such as foot lotion and face make-up. No occurrence data regarding 2-ethylhexyl-2-ethylhexanoate in food in Canada were identified. It was reported as a volatile component of certain foreign food samples, such as wild peanuts (Cherif et al. 2013), muskmelon (Priyanka et al. 2015), roasted barley (Bianchi et al. 2007), and beef (Tansawat et al. 2013). Given the very low concentration present, the limited number of foods in which 2-ethylhexyl-2-ethylhexanoate has been detected, and the fact that the substance is volatile, with expected losses during food preparation, the level of exposure from these sources is likely to be negligible. It is also unlikely that many of the foods in which 2-ethylhexyl-2-ethylhexanoate has been reported to be present would be consumed by the general population of Canadians (Canada 2016).  Based on these considerations, exposure of the general population of Canadians to 2-ethylhexyl-2-ethylhexanoate from food is considered negligible.

In the United States, the national production volume of 2-ethylhexyl-2-ethylhexanoate in 2011 was 35 300 kilograms (78 000 pounds) (CDAT [modified 2014]). Globally, 2-ethylhexyl-2-ethylhexanoate has reported uses as an emollient in cosmetics (Fiume et al. 2015; CosIng 2016).

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5. Exposure source and identified risk

General population exposure to 2-ethylhexyl-2-ethylhexanoate may occur from the use of certain cosmetics, such as foot lotion and face make-up. According to the draft screening assessment of 2-ethylhexyl-2-ethylhexanoate (Canada 2016), dermal exposure was estimated to be 0.37-1.10 mg/kg/d from the use of foot lotion containing 1-3% w/w of 2-ethylhexyl-2-ethylhexanoate (use frequency of 2 times per day) and 0.91-3.05 mg/kg/d from the use of face make-up containing 3-10% w/w of 2-ethylhexyl-2-ethylhexanoate (use frequency of 1.8 times per day).

Substance-specific health effects data were not identified. However, 2-EHA and 2-ethylhexanol (i.e., CAS RNs 149-57-5 and 104-76-7, respectively) are considered relevant to 2-ethylhexyl-2-ethylhexanoate, and were used as analogues where critical health effects data were required. Based on oral studies, 2-EHA was determined to be the more potent of the two analogues, and thus a study for 2-EHA was selected to be conservative. An oral study conducted on laboratory animals revealed developmental health effects at the lowest dose (100 mg/kg-bw/day) following repeated exposure to 2-EHA in rat dams. Margins of exposure comparing effect levels from the oral dosing of 2-EHA in laboratory animals and upper-bounding estimates of dermal exposure ranged from 160-480 for foot lotion and 60-200 for face-makeup and were potentially inadequate to address uncertainties in the health effects and exposure databases for 2-ethylhexyl-2-ethylhexanoate (Canada 2016).

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6. Risk management considerations

6.1 Alternatives and alternate technologies

With respect to foot lotion and face make-up, alternative cosmetic products are available that do not use 2-ethylhexyl-2-ethylhexanoate.

6.2 Socio-economic and technical considerations

Socio-economic factors will be considered in the selection process for a regulation and/or instrument respecting preventive or control actions, and in the development of the risk management objectives(s). Socio-economic factors will also be considered in the development of regulations, instrument(s) and/or tool(s) as identified in the Cabinet Directive on Regulatory Management (TBS 2012a) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action (TBS 2007).

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7. Overview of existing risk management

7.1 related canadian risk management context

2-Ethylhexyl-2-ethylhexanoate is not currently subject to any substance-specific risk management in Canada.

7.2 Pertinent international risk management context

Internationally, the following pertinent risk management action has been taken for 2-ethylhexyl-2-ethylhexanoate:

United States:

2-Ethylhexyl-2-ethylhexanoate is subject to the US Environmental Protection Agency's Toxic Substances Control Act (TSCA) 2016 Chemical Data Reporting (CDR) requirement for which companies must report certain manufacture, import or processing to the US EPA (US EPA 2016).

Europe:

2-Ethylhexyl-2-ethylhexanoate is subject to European Commission Regulations (EC) No 1223/2009 as a substance which is prohibited for use in cosmetics due to its classification as a Category 2 reprotoxic substance (EU 2008), unless an evaluation by the Scientific Committee on Consumer Safety (SCCS) has found the substance safe for use in cosmetic products (EU 2009). As of January 2016, the SCCS has not carried out a safety evaluation of 2-ethylhexyl-2-ethylhexanoate in cosmetics.

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8. Next steps

8.1 Public comment period

Industry and other interested stakeholders are invited to submit comments on the content of this Risk Management Scope or other information that would help to inform decision-making (such as outlined in sections 3.2). Please submit additional information and comments prior to May 24, 2017. The Risk Management Approach document, which will outline and seek input on the proposed risk management instrument(s), will be published at the same time as the final screening assessment. At that time, there will be further opportunity for consultation.

Comments and information submissions on the Risk Management Scope should be submitted to the address provided below:

Environment and Climate Change Canada
Chemicals Management Division
Gatineau Quebec K1A 0H3
Tel: 1-800-567-1999 | 819- 938-3232
Fax: 819-938-5212
Email: Substances@ec.gc.ca

Companies that have a business interest in 2-ethylhexyl-2-ethylhexanoate are encouraged to identify themselves as stakeholders. Stakeholders will be informed of future decisions regarding 2-ethylhexyl-2-ethylhexanoate and may be contacted for further information.

8.2 Timing of actions

 
ActionDate
Electronic consultation on the Risk Management ScopeMarch 25, 2017 to May 24, 2017
Submission of additional studies or information on 2-ethylhexyl-2-ethylhexanoateon or before May 24, 2017
Publication of responses to public comments on the draft screening assessment and Risk Management Scopebefore March, 2018
Publication of the final screening assessment and, if required, the Risk Management Approach documentbefore March, 2018
Publication of responses to public comments on the Risk Management Approach, if applicable, and publication if required, of the proposed instrument(s)24-months from the publication of the final screening assessment
Consultation on the proposed instrument(s), if required60-day public comment period starting upon publication of  the proposed instrument(s)
Publication of the final instrument(s), if required18-months from the publication of the proposed instrument(s)

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9. References

Bianchi F, Careri M, Conti C, Musci M, Vreuls R. 2007. Comparison of comprehensive two-dimensional gas chromatography-time-of-flight mass spectrometry and gas chromatography-mass spectrometry for the qualitative characterisation of roasted barley by solid-phase microextraction. J Sep Sci. 30:527-533.

Canada.2015. Red Tape Reduction Act.

Canada. 2016. Dept. of the Environment, Dept. of Health.draft screening assessment for 2-ethylhexyl-2-ethylhexanoate and calcium 2-ethylhexanoate.

[CDAT] Chemical Data Access Tool. [modified 2014 Jun]. Non-confidential. 2012. Chemical Data Reporting Information: search results for CAS RNs 136-51-6 and 7425-14-1. Washington (DC): US Environmental Protection Agency. [accessed 2016 Jan 15].

Cherif AO, Messaouda MG, Pellerin I, Boukhchina S, Kallel H, Pepe C. 2013. Screening and Profiling of Hydrocarbon Components and Squalene in Developing Tunisian Cultivars and Wild Arachis hypogaea L. Species. J Am Oil Chem Soc. 90:675-686.

[CosIng] Cosmetic Ingredient Database. 2016.

Environment Canada. 2013. DSL Inventory Update data collected under theCanadian Environmental Protection Act, 1999, section71: Notice with respect to certain substances on the Domestic Substances List. Data prepared by: Environment and Climate Change Canada, Health Canada; Existing Substances Program.

[EU] European Union. 2008. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Off J Eur Union L. 353:1-1355.

[EU] European Union. 2009. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Off J Eur Union L. 342:59-209.

Fiume M, Heldreth B, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ et al. 2015. Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics. Int J Toxicol. 34(S3):61S-73S.

Health Canada. 2011. Screening Assessment for the Challenge. Hexanoic acid, 2-ethyl-. Ottawa (ON): Health Canada.

Priyanka D, Sindhoora S, Vijayanand P, Kulkarni SG, Nagaraian S. 2015. Influence of thermal processing on the volatile constituents of muskmelon puree. J Food Sci Tech. 52(5):3111-3116.

Tansawat R, Maughan CAJ, Ward RE, Martini S, Cornforth DP. 2013. Chemical characterisation of pasture- and grain-fed beef related to meat quality and flavour attributes. Int J Food Sci Tech. 48:484-495.

[TBS] Treasury Board of Canada Secretariat. 2007. Assessing, Selecting, and Implementing Instruments for Government Action.

[TBS] Treasury Board of Canada Secretariat. 2012a. Cabinet Directive on Regulatory Management.

[TBS] Treasury Board of Canada Secretariat. 2012b. Red Tape Reduction Action Plan.

[US EPA] United States Environmental Protection Agency. Substance Registry Services (SRS) Database. 2016.

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Appendices

Appendix A. substance targeted for risk management

Substance targeted for risk management
CAS RNDSL name (common name)Chemical structure and molecular formulaMolecular weight (g/mol)
7425-14-1Hexanoic acid, 2-ethyl-, 2-ethylhexyl ester 
(2-Ethylhexyl-2-ethylhexanoate)
Chemical Structure and molecular 7425-14-1
C16H32O2
256.43

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