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Proposed Risk Management Approach
Sulfuric Acid, Diethyl Ester
Chemical Abstracts Service Registry Number (CAS RN)
Table of Contents
- Why we need action
- Current used and industrial sectors
- Presence in the canadian environment and exposure sources
- Overview of existing actions
- Proposed objectives
- Proposed risk management
- Consultation approach
- Next steps / Proposed timeline
This proposed risk management approach document builds on the previously released risk management scope document for diethyl sulfate, and outlines the proposed control actions for this substance. Stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Following this consultation period, the Government of Canada will initiate the development of the specific risk management instrument(s) where necessary. Comments received on the proposed risk management approach will be taken into consideration in developing the instrument(s). Consultation will also take place as instrument(s) are developed.
1.1 Categorization and the Challenge to Industry and Other Iinterested Stakeholders
The Canadian Environmental Protection Act, 1999 (CEPA 1999) (Canada 1999) requires the Minister of the Environment and the Minister of Health (the Ministers) to categorize substances on the Domestic Substances List (DSL). Categorization involves identifying those substances on the DSL that a) are considered to be persistent (P) and/or bioaccumulative (B), based on the criteria set out in the Persistence and Bioaccumulation Regulations, and "inherently toxic" (iT) to humans or other organisms, or b) present, to individuals in Canada, the greatest potential for exposure (GPE). In addition, the Act requires the Ministers to conduct screening assessments of substances that meet the categorization criteria. The assessment further determines whether the substance meets the definition of "toxic" set out in section 64 of the Act.
In December 2006, the Challenge identified 193 chemical substances through categorization which became high priorities for assessment due to their hazardous properties and their potential to pose risks to human health and the environment. In February 2007, the Ministers began publishing, for industry and stakeholder comment, profiles of batches containing 15 to 30 high-priority substances. New batches are released for comment every three months.
In addition, the information-gathering authority in section 71 of CEPA 1999 is used under the Challenge to gather specific information where it is required. The information that is collected through the Challenge will be used to make informed decisions and appropriately manage any risks that may be associated with these substances.
The substance sulfuric acid, diethyl ester, Chemical Abstracts Service Registry Number (CAS RN) 64-67-5, referred to throughout this document by "diethyl sulfate", is included in Batch 4 of the Challenge under the Chemicals Management Plan.
1.2 Final Screening Assessment Report Conclusion for Diethyl Sulfate
A notice summarizing the scientific considerations of a final screening assessment report was published by Environment Canada and Health Canada in the Canada Gazette, Part I, for diethyl sulfate on August 1, 2009 under subsection 77(6) of CEPA 1999. The final screening assessment report (Canada 2009) concluded that diethyl sulfate is entering or may be entering the environment in a quantity or a concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Based on the weight of evidence assessments of international and other national agencies and taking into consideration more recent data, the critical effect for the characterization of risks to human health for diethyl sulfate is carcinogenicity. Increased incidence of tumours (principally at the site of administration) was observed in rats and mice exposed via ingestion, dermal application or subcutaneous injection. Tumours were also observed in pups of rats exposed to diethyl sulfate during pregnancy. Diethyl sulfate was also consistently genotoxic in a range of in vivo and in vitro assays and is a strong DNA alkylating agent. While the mode of induction of tumours by diethyl sulfate has not been fully elucidated, it cannot be precluded that the tumours observed in experimental animals have resulted from direct interaction with genetic material.
On the basis of the carcinogenic potential of diethyl sulfate, for which there may be a probability of harm at any exposure level, it is concluded that diethyl sulfate is a substance that may be 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.
The final screening assessment report also concluded that diethyl sulfate does not meet the criteria for persistence and does not meet the criteria for bioaccumulation, as defined in the Persistence and Bioaccumulation Regulations made under CEPA 1999. The presence of diethyl sulfate in the environment results primarily from human activity.
For further information on the final screening assessment report conclusion for diethyl sulfate, refer to the final screening assessment report, available at http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot_4_e.html.
1.3 Proposed Measure
As a result of a screening assessment of a substance under section 74 of CEPA 1999, the substance may be found to meet one or more of the criteria under section 64 of CEPA 1999. The Ministers can propose to take no further action with respect to the substance, add the substance to the Priority Substances List (PSL) for further assessment, or recommend the addition of the substance to the List of Toxic Substances in Schedule 1 of the Act. Under certain circumstances, the Ministers must make a specific proposal either to recommend addition to the List of Toxic Substances or to recommend the implementation of virtual elimination (or both). In this case, the Ministers proposed to recommend the addition of diethyl sulfate to the List of Toxic Substances in Schedule 1. As a result, the Ministers will develop a regulation or instrument respecting preventive or control actions to protect the health of Canadians and the environment from the potential effects of exposure to this substance.
The final screening assessment report did not conclude that diethyl sulfate meets the conditions set out in subsection 77(4) of CEPA 1999. As a result, diethyl sulfate will not be subject to the virtual elimination provisions under CEPA 1999 and will be managed using a lifecycle approach, to prevent or minimize its release into the environment.
2.1 Substance Information
Diethyl sulfate is part of the chemical grouping discrete organics and the chemical subgrouping esters.
Table 1 presents other names, trade names, chemical groupings, the chemical formula, the chemical structure and the molecular mass for diethyl sulfate.
|Chemical Abstracts Service Registry Number (CAS RN)||64-67-5|
|DSL Name||Sulfuric acid, diethyl ester|
|Inventory names 2||Diethyl sulfate (ECL, PICCS)|
Diethyl sulphate (EINECS)
Sulfuric acid diethyl ester (ECL)
Sulfuric acid, diethyl ester (TSCA, ENCS, AICS, SWISS, PICCS, ASIA-PAC, NZIoC, ECL)
Ethyl sulfate (TAIWAN)
Ethyl sulfate (Et2SO4)
UN 1594 (DOT)
|Major chemical class or use||Esters|
|Major chemical sub-class||Dialkyl sulfate esters|
|Simplified Molecular Input Line Entry System (SMILES)||O=S(=O)(OCC)OCC|
|Molecular mass||154.18 g/mol|
3. Why we need action
3.1 Characterization of Risk
Based on the weight of evidence assessments of several international agencies (IARC 1992, 1999; European Commission 2000; NTP 2005), and taking into consideration more recent data, a critical effect for characterization of risk to human health for diethyl sulfate is carcinogenicity, for which a mode of induction involving direct interaction with genetic material cannot be precluded. Although there are limitations to many of the individual studies in experimental animals, collectively the evidence is considered sufficient. Diethyl sulfate is a strong direct alkylating agent that has induced tumours in rats and mice (including in pups exposed in utero) and has consistently induced genotoxic effects in a range of in vivo and in vitro assays. While the results of available epidemiological studies do not provide any conclusive evidence of carcinogenicity in humans, the observation of respiratory tract tumours in exposed workers is consistent with the evidence from studies in rodents in which diethyl sulfate induced tumours at the site of contact (Canada 2009).
The available database on non-cancer effects induced by diethyl sulfate is very limited. In particular, no adequate data were identified on effects observed in epidemiological studies or in laboratory animals exposed via inhalation (the likely most relevant route of exposure for the general population) to permit derivation of margins of exposure. However, based on the conservative upper bounding estimate of levels in ambient air in Canada and the limited toxicological data available for other routes of exposure, such margins would likely be in the range of many orders of magnitude, and would likely be considered adequately protective for non-cancer effects (Canada 2009).
4. Current used and industrial sectors
According to data submitted in response to the section 71 notice under CEPA 1999, no companies in Canada reported manufacturing diethyl sulfate in a quantity greater than or equal to the threshold of 100 kg for the 2006 calendar year. However, an import of approximately 1000 kg into Canada was reported for the same year (Environment Canada 2008).
According to the three submissions made under section 71 of CEPA 1999, diethyl sulfate is used as a processing aid in the manufacture of abrasive grinding tools and as a chemical intermediate, especially in the paper industry. The substance can be found in residual amounts in chemical additives that are used as tissue softeners and as release technology aids to increase the absorbency of paper media. No Challenge questionnaire submissions or other voluntarily submitted data under the Challenge were received (Environment Canada 2008).
Based on available scientific and technical literature, diethyl sulfate is a powerful ethylating agent used in the preparation of a wide variety of intermediates, especially for dyes, agricultural chemicals, pharmaceuticals and textiles. Diethyl sulfate is commonly used in the manufacture of quaternary ammonium salts, which are used in textile applications as a finishing agent (NTP 2005), as fabric softeners in detergents and in dye and pigment manufacture to increase the affinity of the dye to the fibre (Dow 2006). However, its use in the manufacture of quaternary ammonium salts, which are used as fabric softeners, and its use in agricultural chemicals have not been identified in Canada. Other applications of quaternary ammonium salts include hair care products such as shampoo and conditioner, germicides for disinfectants and sanitizers found in cleaners, drilling fluids and water cooling applications, and in the production of organoclays (Dow 2006). Organoclays are used as viscosity modifiers in a broad range of products including drilling fluids, lubricants, oil-based paints, phase transfer catalysts, electroplating and emulsifying agents, which include asphalt additives and corrosion inhibitors (Dow 2006).
Other applications of diethyl sulfate include its use as a dye-set agent in carbonless paper (NTP 2005) and as an accelerator in ethylene sulfation and sulfonations (HSDB 2003).
This substance is currently not used in cosmetics, but it is not officially prohibited or found on Health Canada’s Cosmetic Ingredient Hotlist (a list of restricted and prohibited cosmetic substances in Canada) (Health Canada 2008a). In Canada, diethyl sulfate is not registered as an active ingredient or a formulant in pest control products (PMRA 2008), nor is it used in fertilizer manufacture or as an approved ingredient in livestock feed in Canada (CFIA 2009). Diethyl sulfate is not included in the Drug Product Database, the Natural Health Products Ingredients Database or the Licensed Natural Health Products Database. Therefore, it is not used in Canada in pharmaceuticals, natural health products or veterinary drugs. Diethyl sulfate has not been identified as being present in these products during initial screening exercises. The Controlled Products Regulations established under the Hazardous Products Act require that this substance be disclosed on the Material Safety Data Sheet that must accompany workplace chemicals when it is present at a concentration of 0.1% or greater, as specified on the Ingredient Disclosure List (Health Canada 2008b). In Canada, diethyl sulfate is not approved as a food additive, nor has it been used in food packaging materials or incidental additives used in food-processing plants. Neither has it been identified as a component of consumer products in Canada.
5. Presence in the canadian environment and exposure sources
5.1 Releases to the Environment
Diethyl sulfate is not manufactured in Canada and domestic supply is met by imports. Emissions of diethyl sulfate into the environment may occur during its use as an ethylating agent in the preparation of a wide variety of intermediates and end products. Production and processing of diethyl sulfate normally occur in closed systems, and no monitoring data on emissions are available (Canada 2009).
Fugitive emissions or venting during the handling, transport or storage of diethyl sulfate could also be sources of release to the atmosphere. Direct releases of diethyl sulfate to the environment are unlikely, since it is mainly used as a chemical intermediate and residuals from production would be rapidly hydrolyzed (Canada 2009).
A report from the United Kingdom states that diethyl sulfate has been detected as a contaminant in thiophosphate insecticides and thus may be released to soil and water (EA 2008). However, diethyl sulfate is not present as a formulant in pest control products in Canada (PMRA 2008).
Under the National Pollutant Release Inventory (NPRI), there were no reportable releases of diethyl sulfate in 2006 or all previous years (NPRI 2007). In recent information gathered under the section 71 notice under CEPA 1999 for diethyl sulfate, no companies reported having released this substance in 2006 (Environment Canada 2008).
5.2 Exposure Sources
Diethyl sulfate is not formed naturally in the environment; its presence results primarily from anthropogenic sources. This chemical may enter the environment during its production and industrial use as an ethylating agent for a wide variety of organic functional groups and in the preparation of a wide variety of intermediates and end products (HSDB 2003). Diethyl sulfate may be released into the environment through various waste streams (HSDB 2003).
No measured concentrations of diethyl sulfate in air in Canada or elsewhere were identified. Although there have been studies investigating the presence of diethyl sulfate in indoor and outdoor air, no quantitative data were reported. Furthermore, there are no monitoring data in water and soil from which upper-bounding exposure can be estimated. However, since diethyl sulfate is rapidly hydrolyzed, levels in environmental media are expected to be negligible (Canada 2009).
As no releases of diethyl sulfate to the atmosphere were reported under the recent section 71 notice (Environment Canada 2008), conservative estimates of levels in air, water and soil were modelled. The predicted concentrations of diethyl sulfate in ambient air are low (approximately 0.7 ng/m3) (ChemCAN 2003). Predicted concentrations for water and soil are also very low (i.e., much less than 10-3 ng/L and 10-3 ng/g, respectively). Likewise, the low log Kow value indicates that accumulation in the food chain is unlikely (Canada 2009).
Potential human exposure may occur as a result of residual diethyl sulfate in formulated end products (e.g., textiles, dyes and pharmaceuticals). However, no data on residuals were identified. Based upon the information provided by companies in Canada under the recent section 71 notice issued in accordance with CEPA 1999, diethyl sulfate is mainly used as an intermediate and has no direct use in consumer products. The substance was also not included in the United States Household Products Database (HPD 2008). Thus consumer exposure is expected to be negligible (Canada 2009).
Confidence in the quantitative estimates of exposure to diethyl sulfate in environment media is considered to be very low to low, as these estimates are based on modeling. However, confidence is high that exposure of the general population to the substance is very limited, in light of the indication that it is not released to the general environment in Canada as well as its very reactive nature (Canada 2009).
6. Overview of existing actions
6.1 Existing Canadian Risk Management
Diethyl sulfate is subject to
- the Controlled Products Regulations established under the Hazardous Products Act, requiring any chemical ingredient on the Ingredient Disclosure List to be disclosed on the Material Safety Data Sheet that must accompany workplace chemicals if present above a certain prescribed concentration (Health Canada 2008b);
- the Regulations for the Prevention of Pollution from Ships and for Dangerous Chemicals established under the Canada Shipping Act, 2001 (Canada 2001); and
- reporting under theNational Pollutant Release Inventory(NPRI 2007).
6.2 Existing International Risk Management
In the United States, diethyl sulfate is subject to the US EPA Clean Air Act (U.S. EPA 2008) under which it is listed as a hazardous air pollutant. It is also listed as a toxic substance under the California Safe Drinking Water and Toxic Enforcement Act (California EPA 2008). Both the European Union (Commission of the European Communities 2008) and New Zealand (Government of New Zealand 2006) prohibit its presence in cosmetics, and Sweden (Swedish Chemical Agency 2006) has classified it as a phase-out substance, whereby, according to a specified timetable, all new products should not contain this substance. Similar to Canada, Australia has regulations for the prevention of the release of diethyl sulfate as a pollutant from ships (Government of South Australia 1987).
7.1 Alternative Chemicals or Substitutes
No information is available on alternative chemicals or substitutes.
7.2 Alternative Technologies and/or Techniques
No information is available on alternative technologies and/or techniques.
7.3 Socio-economic Considerations
Socio-economic factors have been considered in the selection process for a regulation and/or instrument respecting preventive or control actions, and in the development of the risk management objective(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 Streamlining Regulation (Treasury Board of Canada Secretariat 2007) and the guidance provided in the Treasury Board document Assessing, Selecting, and Implementing Instruments for Government Action.
7.4 Children's Exposure
The Government of Canada considered, where available, risk assessment information relevant to children’s exposure to this substance. As part of the Challenge, the Government asked industry and interested stakeholders to submit any information on the substance that may be used to inform risk assessment, risk management and product stewardship. In particular, stakeholders were asked through a questionnaire if any of the products containing the substance were intended for use by children. Given the information received, it is proposed that no risk management actions to specifically protect children are required for this substance at this time.
8. Proposed objectives
8.1 Environmental or Human Health Objective
An environmental or human health objective is a quantitative or qualitative statement of what should be achieved to address environmental or human health concerns identified during a risk assessment. The proposed human health objective for diethyl sulfate is to minimize, to the extent practicable, exposure to diethyl sulfate, and hence risk to human health associated with this substance.
8.2 Risk Management Objective
A risk management objective is a target expected to be achieved for a given substance by the implementation of risk management regulations, instrument(s) and/or tool(s). The proposed risk management objective for diethyl sulfate is to minimize exposure to this substance.
9. Proposed risk management
9.1 Proposed Risk Management Instrument
As required by the Government of Canada's Cabinet Directive on Streamlining Regulation3 and criteria identified in the Treasury Board document entitled Assessing, Selecting, and Implementing Instruments for Government Action, the proposed risk management instrument(s) were selected using a consistent approach, and took into consideration the information that was received through the Challenge and other information available at the time.
In order to achieve the risk management objective and to work towards achieving the environmental or human health objective(s), the risk management being considered for diethyl sulfate is a requirement for notification of the federal government regarding any proposed future uses. In addition, the government will add diethyl sulfate to the Health Canada Cosmetic Ingredient Hotlist, which is an administrative tool to help cosmetic manufacturers satisfy the provisions of section 16 of the Food and Drugs Act. Compliance with the provisions of section 16 are monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations under the Food and Drugs Act. Section 30 requires that all manufacturers and importers provide a list of a cosmetic's ingredients to Health Canada.
Furthermore, the Government has assessed diethyl sulfate in the event that it were to enter the environment as a result of an environmental emergency and has concluded that the substance meets one of the criteria set out in section 200 of CEPA 1999. However, the Government is not proposing to add this substance to the Environmental Emergency Regulations at this time since quantities in Canada are below the threshold of 9100 kg set through the Risk Evaluation Framework for Sections 199 and 200 of CEPA 1999 (Environment Canada 2002).
9.2 Implementation Plan
The proposed regulation or instrument will be published in the Canada Gazette, Part I, no later than August 2011, as per the timelines legislated in CEPA 1999.
Releases of diethyl sulfate will continue to be monitored under the National Pollutant Release Inventory.
10. Consultation approach
The risk management scope for diethyl sulfate, which summarized the proposed risk management under consideration at that time, was published on January 24, 2009. Industry and other interested stakeholders were invited to submit comments on the risk management scope during a 60-day comment period. Comments received on the risk management scope document were taken into consideration in the development of this proposed risk management approach document.
Consultation for the risk management approach will involve publication on August 1, 2009, and a 60-day public comment period.
The primary stakeholders include
- manufacturers and users of chemical intermediates containing diethyl sulfate; and
- Health Canada and Environment Canada.
11. Next steps / Proposed timeline
|Electronic consultation on proposed risk management approach||August 1 to September 30, 2009|
|Response to comments on the risk management approach||At time of publication of proposed instrument|
|Consultation on the draft instrument||Fall/Winter 2009-2010|
|Publication of the proposed instrument||No later than August 2011|
|Formal public comment period on the proposed instrument||No later than October 2011|
|Publication of the final instrument||No later than February 2013|
Industry and other interested stakeholders are invited to submit comments on the content of this proposed risk management approach or provide other information that would help to inform decision making. Please submit comments prior to September 30, 2009 since the risk management of diethyl sulphate will be moving forward after this date. During the development of regulations, instrument(s) and/or tool(s), there will be opportunity for consultation. Comments and information submissions on the proposed risk management approach should be submitted to the address provided below:
Chemicals Management Division
Gatineau, Quebec K1A 0H3
Tel: 1-888-228-0530 / 819-956-9313
Fax: 1-800-410-4314 / 819-953-4936
California EPA. 2008. Office of Environmental Health Hazard Assessment Safe Drinking Water and Toxic Enforcement Act. Available from: http://www.oehha.ca.gov/PROP65/PROP65_LIST/FILES/P65SINGLE091208.PDF
Canada. 1999. Canadian Environmental Protection Act, 1999. S.C. 1999, c. 33. Ottawa: Queen’s Printer. Canada Gazette, Part III 22(3). Available from: http://www.gazette.gc.ca/archives/p3/1999/g3-02203.pdf.
Canada. 2001. Canada Shipping Act. Regulations for the Prevention of Pollution from Ships and for Dangerous Chemicals (SOR/2007-86). Available from: http://laws.justice.gc.ca/en/showdoc/cr/SOR-2007-86//20090401/en?command=HOME&caller=SI&fragment=diethyl%20sulphate&
Canada. 2009. Screening Assessment for the Challenge – Sulfuric Acid, Diethyl Ester (Diethyl Sulfate), Chemical Abstracts Service Registry Number 64-67-5. Available from: http://www.ec.gc.ca/substances/ese/eng/challenge/batch4/batch4_64-67-5.cfm.
[CFIA] Canadian Food Inspection Agency. 2009. Personal communication.
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[Dow] Dow Chemical Company. 2006. Sulfuric Acid, Diethyl Ester (Diethyl Sulfate; CAS RN 64-67-5) High Production Volume (HPV) Challenge Program Final Test Status and Data Review. Prepared for The Dow Chemical Company by ToxicologylRegulatory Services, Inc. November 10, 2006. Available at: http://www.epa.gov/chemrtk/pubs/summaries/slfacdde/c15002rt3.pdf
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Available from: http://laws.justice.gc.ca/en/showdoc/cr/SOR-88-64///en?page=1
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[cited 2008 Sept. 22] Available from: http://hpd.nlm.nih.gov/cgi-bin/household/list?tbl=TblChemicals&alpha=A
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[IARC] International Agency for Research on Cancer. Working Group on the Evaluation of Carcinogenic Risks to Humans. 1992. Occupational exposure to mists and vapours from strong inorganic acids; and other industrial chemicals. IARC Monogr Eval Carcinog Risks Hum. 54:213-228. Available from: http://monographs.iarc.fr/
[IARC] International Agency for Research on Cancer. Working Group on the Evaluation of Carcinogenic Risks to Humans. 1999. Re-evaluation of some organic chemicals, hydrazine and hydrogen peroxide. IARC Monogr Eval Carcinog Risks Hum. 71(Pt3):1405-1415. Available from: http://monographs.iarc.fr/
[NCI] National Chemical Inventories [database on CD-ROM]. 2006. Columbus (OH): American Chemical Society. [cited 2008 May]. Available from: http://www.cas.org/products/cd/nci/index.html
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[NTP] National Toxicology Program. 2005. 11th Report on carcinogens. Substance profile: Diethyl Sulfate. Research Triangle Park (NC): National Toxicology Program. Available from: http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s070diet.pdf
[PMRA] Pest Management Regulatory Agency. 2008. PMRA List of Formulants. Ottawa (ON): Health Canada, Pest Management Regulatory Agency. [cited 2008 July 28]. Available from: http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/reg2007-04/index-eng.php
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2 National Chemical Inventories (NCI). 2007: EINECS (European Inventory of Existing Chemical Substances); and TSCA (Toxic Substances Control Act Chemical Substance Inventory).
3 Section 4.4 of the Cabinet Directive on Streamlining Regulation states that "Departments and agencies are to: identify the appropriate instrument or mix of instruments, including regulatory and non-regulatory measures, and justify their application before submitting a regulatory proposal"
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