Canada Gazette, Part I, Volume 158, Number 4: GOVERNMENT NOTICES
January 27, 2024
DEPARTMENT OF THE ENVIRONMENT DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after assessment of 55 substances in the Aluminium-containing Substances Group, including those specified on the Domestic Substances List and those identified for further consideration following prioritization of the Revised In Commerce List (section 77 of the Canadian Environmental Protection Act, 1999)
Whereas a summary of the draft assessment conducted on the Aluminium-containing Substances Group pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999 (the Act) is annexed hereby;
Whereas 8 of the 55 substances identified in Annex II below are substances identified for further consideration following prioritization of the Revised In Commerce List;
And whereas it is proposed to conclude that aluminum hydroxychloride and aluminum chlorohydrate meet one or more of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to Her Excellency the Governor in Council that these two substances be added to Part 2 of Schedule 1 to the Act.
Notice is furthermore given that the ministers have released a risk management scope document for these two substances to initiate discussions with stakeholders on the development of risk management options.
And whereas it is proposed to conclude that the remaining 53 substances do not meet any of the criteria set out in section 64 of the Act,
Notice is further given that the ministers propose to take no further action on the remaining substances at this time.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Substance Prioritization, Assessment, and Coordination Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by email to substances@ec.gc.ca or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science Reporting and Assessment Directorate
On behalf of the Minister of the Environment
Cécile Siewe
Director General
Industrial Sectors and Chemicals Directorate
On behalf of the Minister of the Environment
Greg Carreau
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX I
Summary of the draft assessment of the Aluminium-containing Substances Group
Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted an assessment of 55 substances referred to collectively as the Aluminiumfootnote 1 Substances Group. The potential for cumulative effects was considered in this assessment by examining cumulative exposures to the aluminium moiety.
There are both natural and anthropogenic sources of aluminium exposure to humans and the environment. Natural sources of aluminium include weathering and biogeochemical processes, which, in combination with deposition processes, contribute to a complex aluminium cycle in the environment. Anthropogenic sources include the production of aluminium (for example smelting), cement production, metal mining, electric power generation, pulp and paper manufacturing, and the use of products and manufactured items containing aluminium compounds.
According to information submitted in response to CEPA section 71 surveys, of the 54 substances surveyed, 40 substances in the group were manufactured or imported above the reporting threshold of 0.1 tonnes in 2011 or 2015. Results of the surveys indicated that 8 of the 54 surveyed substances were manufactured in Canada above reporting thresholds and that 37 of the 54 surveyed substances were imported into Canada above reporting thresholds. Of the 40 substances manufactured or imported above the reporting threshold of 0.1 tonnes, 12 were manufactured or imported in quantities exceeding 1 000 tonnes. These substances are used in a wide variety of products and applications including in arts, crafts and hobby materials; automotive care products; building and construction materials; cleaning products; food packaging; ink, toner, and colourants; self-care products (cosmetics, natural health products, and non-prescription drugs); paints and coatings; pest control products; plastics; textiles; and other industrial and commercial uses.
Substances in the Aluminium-containing Substances Group have the potential to dissolve, dissociate, or degrade through various transformation pathways and therefore potentially contribute to exposures to total aluminium. Therefore, total aluminium concentrations, modelled or measured, were used as a surrogate for the potential exposure from the 55 substances in the group. Ecological hazards were characterized accordingly in order to evaluate the potential for harm from exposure to total aluminium.
The ecological exposure assessment focuses on sectors with the highest commercial activity involving substances in the group as well as those with the largest releases of aluminium reported to the National Pollutant Release Inventory. Specifically, exposure scenarios were developed for primary aluminium manufacturing, cement manufacturing, metal mining, electric power generation, and pulp and paper manufacturing. Predicted environmental concentrations (PEC) were derived for each of these sectors, using monitoring data in the receiving environment, monitoring data in effluents or industrial emission factors. Canadian long-term surface water quality monitoring data associated with land use classifications and available data on concentrations of bioavailable aluminium in soil were also used to characterize exposure.
The ecological hazard assessment for the aquatic compartment considers total concentrations of aluminium and the toxicity modifying factors such as pH, water hardness, and dissolved organic carbon. Predicted no effect concentrations (PNEC) were generated in alignment with the Federal Water Quality Guidelines for Aluminium. For soils, a PNEC was derived from published calcium chloride extractable aluminium thresholds. These accounted for bioavailability in soil and, on the basis of the data available, were considered to be protective of both terrestrial plants and soil invertebrates.
Aluminium is considered to be persistent in the environment, as are all elements, but may change speciation and cycle between environmental compartments. Although there are certain tolerant and hyper-accumulating plant species, aluminium is not generally considered to be bioaccumulative.
The analysis of aquatic risk quotients for each sector showed that PECs infrequently exceeded PNECs, suggesting a lower potential to cause ecological harm. For the soil compartment, the PNEC was compared with corresponding exposure data as a function of pH. In the range of pH values where anthropogenic releases of substances in the group would occur, the soil PNEC was not exceeded. For the sediment compartment, based on the qualitative lines of evidence considered, the 55 aluminium-containing substances were found to have a low potential to cause ecological harm.
Considering all available lines of evidence presented in this draft assessment, there is a low risk of harm to the environment from the 55 aluminium-containing substances. It is proposed to conclude that the 55 aluminium-containing substances do not meet the criteria under paragraph 64(a) or (b) of CEPA as they 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.
Canadians may be exposed to substances in the Aluminium-containing Substances Group through environmental media (soil, house dust, and air), food, and drinking water. Traditional, subsistence, or country foods may be a source of aluminium exposure for certain Indigenous communities in Canada. People living near industrial facilities, such as primary aluminium smelters, may be exposed to elevated concentrations of aluminium from point source emissions. In addition, Canadians are exposed to aluminium from a variety of products and manufactured items available to consumers.
The systemic exposure of the general Canadian population over the age of 3 to substances in the Aluminium-containing Substances Group was characterized using nationally representative biomonitoring data. Aluminium was measured in biobanked samples of whole blood from Cycle 2 of the Canadian Health Measures Survey (CHMS). Aluminium content in whole blood samples provides a biologically relevant, integrated measure of systemic exposure that may occur across multiple routes (for example oral ingestion, dermal contact, and inhalation) and sources (for example natural and anthropogenic, environmental media, diet, and frequent or daily-use products). Aluminium levels were below the method reporting limit of 8 µg/L in 97.1% of the Canadian population (age group 3 to 79). For children under the age of 3, biomonitoring data from small-scale studies and intake estimates from environmental media, food, and drinking water were considered to characterize risk. Dietary intake estimates for certain Indigenous communities were also considered to characterize risk.
Inhalation exposure scenarios from the use of products available to consumers and ambient air concentrations, including in proximity to point sources of releases, were quantified separately in order to assess the potential risk of portal of entry effects in the lungs. Substances in the Aluminium-containing Substances Group are found in a range of aerosol, trigger spray, and loose powder products, the uses of which may result in inhalation exposure. These products include self-care products (that is, cosmetics, natural health products, and non-prescription drugs), paints and coatings, do-it-yourself products (for example cement products, tile grout), and cleaning products. In addition, aluminum hydroxychloride (CAS RNfootnote 2 1327-41-9) and aluminum chlorohydrate (CAS RN 12042-91-0) are used in aerosol and powdered antiperspirant and deodorant products.
Several international organizations have established health-based guidance values for aluminium (for example tolerable weekly intakes), which were established on the basis of neurological, neurodevelopmental, and reproductive effects. Thus, to characterize human health risk, a whole blood biomonitoring equivalent (BE) was derived for daily intake levels associated with the provisional tolerable weekly intake (PTWI) established on the basis of a critical endpoint that was identified from a developmental and chronic neurotoxicity study by the Joint Food and Agriculture Organization of the United Nations / World Health Organization Expert Committee on Food Additives (JECFA). With respect to inhalation exposure, a no-observed adverse effect concentration (NOAEC) from a worker study was identified as a route-specific endpoint for the Aluminium-containing Substances Group. In addition, repeated inhalation of aluminium chlorohydrate generates lung effects that are not observed after inhalation of other aluminium-containing substances. As a result, granulomatous pneumonia was selected as a route-specific critical health effect for aluminum hydroxychloride and aluminum chlorohydrate.
Median and 95th percentile concentrations of total aluminium in whole blood from the CHMS were lower than the derived BE value. Average plasma aluminium concentrations in infants under three years old from small-scale biomonitoring studies were also lower than the derived BE value. Furthermore, intake estimates from environmental media, food, and drinking water for children under three years old as well as intake estimates from the consumption of country foods for certain Indigenous communities were lower than the daily intake level associated with the JECFA PTWI. Therefore, systemic exposure to the aluminium-containing substances is considered to be of low concern to the health of Canadians at current levels of exposure. In addition, the resulting margins of exposure estimated for inhalation exposure and the NOAEC for 53 of the 55 aluminium-containing substances were considered adequate to address uncertainties in the available health effects and exposure data used to characterized risk. Margins of exposure between levels of inhalation exposure from the use of aerosol antiperspirants and aerosol foot deodorant spray and the critical health effect for aluminum hydroxychloride (CAS RN 1327-41-9) and aluminum chlorohydrate (CAS RN 12042-91-0) were considered potentially inadequate to address uncertainties in the available health effects and exposure data used to characterize risk.
The human health assessment took into consideration those groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. Human biomonitoring data were available for infants, children and pregnant women and pregnant people. These subpopulations were taken into account in the risk assessment outcomes of aluminum-containing substances. In addition, exposure from consuming traditional, subsistence or country foods for certain Indigenous communities and exposure from outdoor air for people living near sources of release were examined.
Considering all the information presented in this draft assessment, it is proposed to conclude that aluminum hydroxychloride (CAS RN 1327-41-9) and aluminum chlorohydrate (CAS RN 12042-91-0) meet the criteria under paragraph 64(c) of CEPA as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Considering all the information presented in this draft assessment, it is proposed to conclude that 53 of the 55 aluminium-containing substances do not meet the criteria under paragraph 64(c) of CEPA as they are 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.
Proposed overall conclusion
It is therefore proposed to conclude that aluminum hydroxychloride (CAS RN 1327-41-9) and aluminum chlorohydrate (CAS RN 12042-91-0), meet one or more of the criteria set out in section 64 of CEPA. It is proposed to conclude that the remaining 53 aluminium-containing substances do not meet any of the criteria set out in section 64 of CEPA.
It is also proposed to conclude that aluminum hydroxychloride and aluminum chlorohydrate meet the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
The draft assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical substances) website.
ANNEX II
| CAS RN | List | DSL or R-ICL name | Common name |
|---|---|---|---|
| 75-24-1 | DSL | Aluminum, trimethyl- | Trimethylaluminum |
| 96-10-6 | DSL | Aluminum, chlorodiethyl- | Diethylaluminum chloride |
| 97-93-8 | DSL | Aluminum, triethyl- | Triethylaluminum |
| 300-92-5 table a1 note a | DSL | Aluminum, hydroxybis(octadecanoato-O)- | Aluminum distearate |
| 563-43-9 | DSL | Aluminum, dichloroethyl- | Ethylaluminum dichloride |
| 1070-00-4 | DSL | Aluminum, trioctyl- | Trioctylaluminum |
| 1116-73-0 | DSL | Aluminum, trihexyl- | Trihexylaluminum |
| 1302-42-7 | DSL | Aluminate (AlO21-), sodium | Sodium aluminate |
| 1317-25-5 | DSL | Aluminum, chloro[(2,5-dioxo-4-imidazolidinyl)ureato]tetrahydroxydi- | Alcloxa; Aluminum chlorhydroxy allantoinate |
| 1327-41-9 table a1 note b | DSL | Aluminum chloride, basic | Aluminum hydroxychloride |
| 1328-04-7 table a1 note b | DSL | C.I. Pigment Violet 5:1 | N/A |
| 1344-28-1 | DSL | Aluminum oxide (Al2O3) | N/A |
| 5579-81-7 | DSL | Aluminum, [(2,5-dioxo-4-imidazolidinyl)ureato]dihydroxy- | Aldioxa; Aluminum dihydroxy allantoinate |
| 7784-18-1 | DSL | Aluminum fluoride (AlF3) | N/A |
| 7784-25-0 | DSL | Sulfuric acid, aluminum ammonium salt (2:1:1) | Ammonium alum (anhydrous) |
| 7784-26-1 | DSL | Sulfuric acid, aluminum ammonium salt (2:1:1), dodecahydrate | Ammonium alum |
| 7784-28-3 | DSL | Sulfuric acid, aluminum sodium salt (2:1:1), dodecahydrate | Sodium alum |
| 7785-88-8 | DSL | Phosphoric acid, aluminum sodium salt | Sodium aluminum phosphate |
| 10043-67-1 | DSL | Sulfuric acid, aluminum potassium salt (2:1:1) | Potassium alum (anhydrous) |
| 10102-71-3 | DSL | Sulfuric acid, aluminum sodium salt (2:1:1) | Sodium alum (anhydrous) |
| 10279-59-1 table a1 note c | R-ICL | Phosphoric acid, aluminum sodium salt (8:2:3) | Sodium aluminum phosphate (anhydrous) |
| 10305-76-7 table a1 note c | R-ICL | Phosphoric acid, aluminum sodium salt (8:3:1), tetrahydrate | Sodium aluminum phosphate |
| 11097-59-9 | DSL | Magnesium, [carbonato(2-)]hexadecahydroxybis(aluminum)hexa- | Synthetic hydrotalcite |
| 11138-49-1 table a1 note b | DSL | Aluminum sodium oxide | Sodium aluminate |
| 12004-11-4 | DSL | Aluminate(8-), hexaoxo[sulfato(2-)]di-, calcium (1:4) | Aluminum calcium oxide sulfate (Al2Ca4O6(SO4)) |
| 12004-14-7 | DSL | Aluminate(12-), hexaoxotris[sulfato(2-)]di-, calcium (1:6) | Aluminum calcium oxide sulfate (Al2Ca6O6(SO4)3) |
| 12005-57-1 | DSL | Aluminate (Al14O3324-), calcium (1:12) | Aluminum calcium oxide (Al14Ca12O33) |
| 12042-68-1 | DSL | Aluminate (AlO21-), calcium (2:1) | Aluminum calcium oxide (Al2CaO4) |
| 12042-78-3 | DSL | Aluminate (AlO33-), calcium (2:3) | Aluminum calcium oxide (Al2Ca3O6) |
| 12042-91-0 | DSL | Aluminum chloride hydroxide (Al2Cl(OH)5) | Aluminum chlorohydrate |
| 13419-15-3 | DSL | Aluminum, (octadecanoato-O)oxo- | Aluminum oxystearate |
| 14782-75-3 | DSL | Aluminum, (ethyl 3-oxobutanoato-O1’,O3)bis(2-propanolato)-, (T-4)- | Aluminum diisopropoxide ethylacetoacetate |
| 15096-52-3 | DSL | Cryolite | N/A |
| 15305-07-4 | DSL | Aluminum, tris(N-hydroxy-N-nitrosobenzenaminato-O,O’)- | Aluminum cupferronate |
| 15876-39-8 table a1 note c | R-ICL | Spiro[isobenzofuran-1(3H),9’-[9H]xanthen]-3-one,2’,4’,5’,7’-tetrabromo-3’,6’-dihydroxy, aluminum salt (3:2) | C.I. Pigment Red 90:1 |
| 21645-51-2 | DSL | Aluminum hydroxide (Al(OH)3) | N/A |
| 30745-55-2 | DSL | Aluminum, bis(2-ethylhexanoato-o)hydroxy- | Hydroxyaluminum bis(2-ethylhexanoate) |
| 31142-56-0 | DSL | Aluminum citrate | N/A |
| 39290-78-3 | DSL | Aluminium chloride hydroxide sulfate | Polyaluminum chloride hydroxide sulfate |
| 53810-32-5 | DSL | Aluminum hydroxide sulfate (Al4(OH)6(SO4)3) | N/A |
| 54182-58-0 table a1 note c | R-ICL | Aluminum, hexadeca-µ-hydroxytetracosahydroxy[µ8-[[1,3,4,6-tetra-O-sulfo-β-D-fructofuranosyl α-D-glucopyranoside tetrakis(sulfato-κO’)](8-)]]hexadeca- | Sucralfate |
| 54326-11-3 | DSL | Aluminum, (benzoato-O,O’)hydroxy(octadecanoato-O,O’)- | Aluminum hydroxide benzoate stearate |
| 56639-51-1 table a1 note c | R-ICL | Aluminum, hydroxybis(tetradecanoato-κO)- | Aluminum dimyristate |
| 57158-29-9 table a1 note b | DSL | Aluminum zirconium chloride hydroxide | Aluminum zirconium complexes |
| 57455-37-5 table a1 note b | DSL | C.I. Pigment Blue 29 | N/A |
| 65997-15-1 table a1 note b | DSL | Cement, portland, chemicals | N/A |
| 65997-16-2 table a1 note b | DSL | Cement, alumina, chemicals | N/A |
| 68131-74-8 table a1 note a table a1 note b | DSL | Ashes (residues) | N/A |
| 68425-65-0 | DSL | Aluminum, oxo(2-propanolato)- | N/A |
| 68475-50-3 table a1 note c | R-ICL | Aluminum, tris[5-amino-4-hydroxy-3-(phenylazo)-2,7-naphthalenedisulfonato(2-)]di- | N/A |
| 68647-58-5 table a1 note b | DSL | Aluminum, benzoate hydrogenated tallow fatty acid iso-Pr alc. complexes | N/A |
| 68855-54-9 table a1 note b | DSL | Kieselguhr, soda ash flux-calcined | Flux-calcined diatomaceous earth |
| 70131-50-9 table a1 note b | DSL | Bentonite, acid-leached | N/A |
| 90604-80-1 table a1 note c | R-ICL | Zirconium, chloro glycine hydroxy aluminum complexes | Aluminum zirconium complexes |
| 134375-99-8 table a1 note c | R-ICL | Aluminum zirconium trichlorohydrex gly | Aluminum zirconium complexes |
Table a1 note(s)
|
|||
Abbreviations: N/A, not available; DSL, Domestic Substances List; R-ICL, Revised In Commerce List
DEPARTMENT OF THE ENVIRONMENT DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after assessment of two substances — 2-pyrrolidinone, 1-methyl-(N-methylpyrrolidinone; NMP), CAS RN footnote 2 872-50-4, and 2-pyrrolidinone, 1-ethyl-(N-ethylpyrrolidinone; NEP), CAS RN 2687-91-4 — specified on the Domestic Substances List (section 77 of the Canadian Environmental Protection Act, 1999)
Whereas a summary of the updated draft assessment conducted on NMP and NEP pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;
And whereas it is proposed to conclude that NMP meets one or more of the criteria set out in section 64 of the Act;
And whereas it is proposed to conclude that NEP does not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to Her Excellency the Governor in Council that NMP be added to Part 2 of Schedule 1 to the Act.
Notice is furthermore given that the ministers have released a risk management scope document for NMP to initiate discussions with stakeholders on the development of risk management options.
Notice therefore is hereby given that the ministers propose to take no further action on NEP at this time.
Notice is further given that options are being considered for follow-up activities to track changes in exposure to NEP.
Public comment period
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Substance Prioritization, Assessment and Coordination Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by email to substances@ec.gc.ca or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
Jacqueline Gonçalves
Director General
Science Reporting and Assessment Directorate
On behalf of the Minister of the Environment
Cécile Siewe
Director General
Industrial Sectors and Chemicals Directorate
On behalf of the Minister of the Environment
Greg Carreau
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the updated draft assessment of NMP and NEP
Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted an assessment of two substances, N-methyl-2-pyrrolidone (NMP) and N-ethyl-2-pyrrolidone (NEP). The Chemical Abstracts Service Registry Numbers (CAS RNs), the Domestic Substances List (DSL) names, the common names, and the abbreviations of these substances are listed in the table below. A draft screening assessment for NMP and NEP was published in February 2017. New information subsequently became available regarding exposure to products containing NMP and NEP available to consumers, which had the potential to alter assessment conclusions. As a result, the draft assessment was updated.
| CAS RN | DSL name | Common name (abbreviation) |
|---|---|---|
| 872-50-4 | 2-Pyrrolidinone, 1-methyl- | N-methylpyrrolidone (NMP) |
| 2687-91-4 | 2-Pyrrolidinone, 1-ethyl- | N-Ethylpyrrolidone (NEP) |
NMP and NEP are anthropogenic substances that do not occur naturally in the environment. According to information submitted in response to a CEPA section 71 survey, NMP is used in chemical manufacturing and automotive, aircraft, and transportation sectors in Canada, including the manufacture of agricultural products, electrical and electronic products, metal and mining products, paper products, mixtures or manufactured items, and plastic and rubber materials. Products in Canada that contain NMP, and that may be available to the general population, include adhesives and sealants, auto interior cleaners, cleaning and degreasing products, paints and coatings, and paint removers. NMP may be present in certain personal care products, including as a non-medicinal ingredient in pharmaceuticals and in a limited number of nail care, synthetic nail or eyelash adhesives and adhesive removers, and hair products. NMP is also present as a formulant in certain registered pest control products. According to information submitted in response to a CEPA section 71 survey, NEP is used in chemical manufacturing as well as in manufacturing adhesives and sealants, paints and coatings, and plastic and rubber materials in Canada. NEP was not identified in any products available to Canadian consumers.
According to information submitted in response to a CEPA section 71 survey, NMP was imported into Canada in a quantity range of 100 000 kg to 1 000 000 kg, and NEP was imported in a quantity range of 1 000 kg to 10 000 kg during the 2011 calendar year. Neither substance was reported to be manufactured in Canada in quantities above the survey reporting threshold of 100 kg. Given the similar physical-chemical properties of these substances, they may be used interchangeably.
The ecological risks of NMP and NEP were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate, or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, NMP and NEP are considered unlikely to be causing ecological harm.
Considering all available lines of evidence presented in this updated draft assessment, there is a low risk of harm to the environment from NMP and NEP. It is proposed to conclude that NMP and NEP do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they 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.
For the general population of Canada, the predominant source of exposure to NMP is from the use of products available to consumers that contain this substance. Dermal and inhalation routes of exposure may both contribute to potential NMP exposure. Estimates of potential exposure to NMP were derived for environmental media (air), use of adhesives, driveway sealer, and personal care products.
Estimates of exposure were not derived for NEP, as no consumer uses or releases of NEP to the environment were identified. As exposure to NEP for the general population is not expected, the potential risk to human health is considered to be low.
NMP and NEP have been reviewed internationally by the U.S. Environmental Protection Agency (U.S. EPA) and the European Chemicals Agency (ECHA), respectively. Both NMP and NEP have been classified by ECHA as suspected reproductive toxicants (category 1B). A reproductive 1B classification also includes adverse effects to a conceptus, before or after birth.
In laboratory studies, NMP was identified as a reproductive and developmental toxicant. Margins between levels of exposure of NMP to the general population and the critical effect level were considered inadequate to address uncertainties in the health effects and exposure data from the intermittent use of deck construction adhesives. Margins for all other uses were considered adequate.
The human health assessment took into consideration those groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects. Consideration of laboratory studies on rats suggests that pregnant people and the prenatal life stage were found to be susceptible to developmental effects of NMP during acute exposures to NMP. People of reproductive age were found to be susceptible to reproductive effects (i.e. reduced fertility or fecundity) during chronic exposure to NMP. Compared with adolescents and adults, one-year-old infants were found to have higher exposures to NMP from estimated NMP levels in air. In the assessment of exposure from products, exposure estimates were highest for teenage females. All of these populations were taken into consideration when addressing the potential harm to human health.
Considering all the information presented in this updated draft assessment, it is proposed to conclude that NMP meets the criteria under paragraph 64(c) of CEPA, as it is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health. Considering all the information presented in this updated draft assessment, it is proposed to conclude that NEP does not meet the criteria under paragraph 64(c) of CEPA, as 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.
Proposed overall conclusion
It is therefore proposed to conclude that NMP meets one or more of the criteria set out in section 64 of CEPA. It is also proposed to conclude that NEP does not meet any of the criteria set out in section 64 of CEPA.
It is also proposed to conclude that NMP does not meet either the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
Consideration for follow-up
While exposure of the general population or the environment to NEP is not of concern at current levels, this substance is associated with effects of concern. Therefore, there may be concern if exposure were to increase. Follow-up activities may be considered in future initiatives to track its commercial status or identify new uses or exposures.
Stakeholders are encouraged to provide, during the 60-day public comment period on the updated draft assessment, any information pertaining to the substance that may help inform the choice of follow-up activity. This could include information on new or planned import, manufacture or use of the substance, if the information has not previously been submitted to the ministers.
The updated draft assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical substances) website.
DEPARTMENT OF THE ENVIRONMENT DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of final decision after assessment of two substances — naphthenic acids, CAS RN footnote 2 1338-24-5, and naphthenic acids, calcium salts (calcium naphthenates), CAS RN 61789-36-4 — specified on the Domestic Substances List (section 77 of the Canadian Environmental Protection Act, 1999)
Whereas a summary of the assessment conducted on calcium naphthenates and the substance bearing CAS RN 1338-24-5 pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999 is annexed hereby;
And whereas it is concluded that the substances do not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the Minister of the Environment and the Minister of Health propose to take no further action on these substances at this time under section 77 of the Act.
Steven Guilbeault
Minister of the Environment
Mark Holland
Minister of Health
ANNEX
Summary of the assessment of the Commercial Naphthenic Acids Group
Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted an assessment of two substances referred to collectively under the Chemicals Management Plan (CMP) as the Naphthenic Acids and Salts Group, hereinafter referred to as the Commercial Naphthenic Acids Group.
The Chemical Abstracts Service Registry Number (CAS RN), the Domestic Substances List (DSL) name and the common name of the substances of this group are listed in the table below.
| CAS RN | DSL name | Common name |
|---|---|---|
| 1338-24-5 table b1 note a | Naphthenic acids | N/A |
| 61789-36-4 table b1 note a | Naphthenic acids, calcium salts | Calcium naphthenates |
Table b1 note(s)
|
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Abbreviation: N/A, not applicable
This assessment addresses two commercial naphthenic acids obtained via the extraction of petroleum distillates: naphthenic acids (CAS RN 1338-24-5), hereinafter referred to by its CAS RN, and naphthenic acids, calcium salts (CAS RN 61789-36-4), hereinafter referred to as calcium naphthenates. Nineteen other commercial naphthenic acids and commercial salts of naphthenic acids have been or are being addressed through various approaches under the Chemicals Management Plan.footnote 3 Commercial naphthenic acids differ from complex mixtures of naphthenic acids present as a by-product in oil sands process-affected water (OSPW) generated from oil sands mining, and from extraction and processing of bitumen. OSPW naphthenic acids differ in source, composition, properties and use compared to commercial naphthenic acids. OSPW naphthenic acids do not have associated CAS RNs and are not included on the DSL; therefore, they were not subject to categorization of the DSL and are not considered in this assessment. Activities to better understand OSPW naphthenic acids have been initiated under the Canada–Alberta Oil Sands Monitoring Program, and are being pursued by Environment and Climate Change Canada, notably targeting the presence and effects of naphthenic acids in tailing ponds’ seepage. In addition, Environment and Climate Change Canada has added naphthenic acid fraction compounds (which include diverse polar organic compounds present in bitumen and OSPW) and their salts to the National Pollutant Release Inventory, beginning with the 2020 reporting year. This addition does not include naphthenic acids and their salts used solely in the context of commercial mixtures.
In Canada, the substance bearing CAS RN 1338-24-5 and calcium naphthenates were not reported to be manufactured above the reporting threshold in 2011 in response to a survey issued pursuant to section 71 of CEPA. Import quantities reported in the survey were in the range of 100 000 kg to 1 000 000 kg for the substance bearing CAS RN 1338-24-5 and between 1 000 kg and 10 000 kg for calcium naphthenates.
In Canada and internationally, the substance bearing CAS RN 1338-24-5 is mainly found in lubricants and greases, and in paints and coatings that are intended for professional/industrial use only. Lubricants and greases containing the substance bearing CAS RN 1338-24-5 are used primarily in the industrial, transportation and aviation sectors, while paints and coatings containing the substance bearing CAS RN 1338-24-5 are used in the automotive and industrial sectors. The substance bearing CAS RN 1338-24-5 has also been identified as a component of inks used in the manufacture of polymeric coatings used to package some foods. No use of calcium naphthenates in products available to consumers was identified.
The ecological risks of the substance bearing CAS RN 1338-24-5 and of calcium naphthenates were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based primarily on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances based on their hazard and exposure profiles. Based on the outcome of the ERC analysis, the substance bearing CAS RN 1338-24-5 and calcium naphthenates are considered unlikely to be causing ecological harm.
Considering all available lines of evidence presented in this assessment, there is a low risk of harm to the environment from the substance bearing CAS RN 1338-24-5 and from calcium naphthenates. It is concluded that the substance bearing CAS RN 1338-24-5 and calcium naphthenates do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they 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.
The substance bearing CAS RN 1338-24-5 and calcium naphthenates were not identified as posing a high hazard to human health on the basis of absence of classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. In addition, exposure of the general population to the substance bearing CAS RN 1338-24-5 and to calcium naphthenates through environmental media, food, or the use of products available to consumers is expected to be minimal, and the potential risk to human health is considered to be low.
The human health assessment took into consideration those groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects. For the Commercial Naphthenic Acids Group, these subpopulations were considered; however, exposures were expected to be minimal based on use patterns and therefore were not quantified.
Considering all the information presented in this assessment, it is concluded that the substance bearing CAS RN 1338-24-5 and calcium naphthenates do not meet the criteria under paragraph 64(c) of CEPA, as they are 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.
Overall conclusion
It is therefore concluded that the substance bearing CAS RN 1338-24-5 and calcium naphthenates do not meet any of the criteria set out in section 64 of CEPA.
The assessment for these substances is available on the Canada.ca (Chemical substances) website.
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