Data gap analysis of nanoscale forms of substances on the Domestic Substances List: a human health perspective
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1. Purpose
This document describes the approach used by Health Canada (HC) to analyze available data and information on certain nanomaterials. It also presents the results of this analysis and identifies data needs for each of 53 nanomaterials previously reported as being in-commerce in Canada through a mandatory survey under section 71 (s.71) of the Canadian Environmental Protection Act, 1999 (CEPA) (Canada, 2015a).
HC is inviting interested partners and stakeholders to provide information about the 53 substances with nanoscale forms in commerce in Canada. Information provided will inform the path forward for assessment under the Chemicals Management Plan (CMP) and help tailor assessment and management approaches.
2. Background
Under the CMP, nanoscale forms of certain substances on the Domestic Substances List (DSL) are being addressed separately from their non-nanoscale forms (that is, bulk forms). As previously described in the Consultation Document: Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List (ECCC, 2017), this process involves a step-wise approach consisting of 3 phases:
- establishment of a list of existing nanomaterials in Canada
- prioritization of existing nanomaterials for action
- action on substances identified for further work
In 2015, a mandatory survey under s.71 of CEPA was launched, which required a response from any person who manufactured or imported any of the 206 nanomaterials (suspected to be in commerce in Canada) in a quantity greater than 100 kg during the 2014 calendar year. Respondents were required to submit information to Environment and Climate Change Canada, including the quantity in commerce and uses. Based on the information received, 53 nanomaterials were determined to be in-commerce in Canada and have been subjected to further analysis according to the approach described below (see section 4, table 1 for the list of CAS RNs).
3. Approach
The data gap analysis started with a prioritization exercise described in a consultation document published in July 2016 (Canada, 2016). A stakeholder consultation workshop was also held in the same year. The feedback from this workshop, together with public comments received, was considered in developing the approach described here.
The data gap analysis takes into consideration multiple sources of information, including the 2015 s.71 survey, peer-reviewed scientific literature, publically available databases on nanomaterial use and toxicity up to 2020, as well as outcomes of international activities [for example, initiatives of the Canada-United States (U.S.) Regulatory Cooperation Council (RCC) and the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials (OECD WPMN)].
The overall analysis is qualitative in nature and uses a matrix approach. Available human-health-related information (exposure and hazard) for each of the 53 nanomaterials was reviewed to identify the exact data needs associated with each CAS RN for conducting regulatory risk assessment. Key considerations are described in the following sections.
3.1 Exposure
An initial screen for exposure data gaps considered the import and/or manufacture quantities in Canadian commerce in 2014, the use pattern of the nanomaterial identified from s.71 survey submission, as well as literature searches. For the purposes of this exercise, only direct exposure via consumer uses or food intake was considered, whereas indirect exposure via environmental media (for example, ambient air) will be taken into account during the risk assessment phase as appropriate.
Import/manufacture volume
The total import and/or manufacture volume reported under the s.71 survey for the 2014 calendar year was assigned as level 1 from 100 to 10 000 kg, level 2 from 10 000 to 100 000 kg and level 3 for greater than 100 000 kg. As the s. 71 reporting threshold was set as 100 kg/year, any CAS RN with a quantity lower than 100 kg/year is not subject to analysis at this time.
Use
Apart from the known import/manufacturer quantity, use information was also taken into account, including uses in products available to consumers (for example, cleaners, paints, personal care products, or cosmetics), uses in products intended for children, food or food packaging, or commercial or industrial uses. For a given nanomaterial, known uses in Canada were identified from submissions received pursuant to the s.71 survey and follow-up information gathered from other regulatory programs. An additional literature search was conducted to identify other uses in North America or globally but such uses in Canada remain to be confirmed, as specified in table 1. To this end, numerous sources were consulted, including, but not limited to the following:
Domestic
- information from a mandatory CEPA s.71 survey (Canada, 2015a)
- HC's Lists of permitted food additives
- HC's Natural Health Products Ingredients Database
- HC's licensed natural health products database
- HC's Drug Product Database
- notifications submitted under the Cosmetic Regulations to HC
- notifications submitted under the Food and Drugs Act to HC
International
- nanotechnology databases - various internet sources such as Nanowerk, Nanotechnology Products Database, Danish Nanodatabase
- ANSES nanomaterials registry
- French Ministry of Ecology, Sustainable Development and Energy Market reports (2014-2016)
- The European Chemicals Agency (ECHA) inventory database
- OECD search portal to information on chemical substances (eChemPortal)
- Everything Added to Food in the United States Database (EAFUS)
- U.S. Food and Drug Administration's List of Indirect Additives used in Food Contact Substances
- European Commission's cosmetic ingredient database (COSING)
- EWG’s Skin Deep cosmetics database
- American Cleaning Institute (ACI) ingredient list
- International Fragrance Association (IFRA) Transparency List
- Consumer Product Information Database
- Material Safety Data Sheets (MSDSs) - mainly Canadian and U.S. MSDSs through MSDS search tool
- national and international assessments, including ECHA registered substances, International Programme on Chemical Safety (INCHEM), Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS), U.S. National Toxicology Program Report on Carcinogens (NTP ROC) and International Agency for Research on Cancer (IARC)
Similar to the volume-level system described above, 3 levels were set for uses identified for a given substance. Nanomaterials with only industrial uses were set as level 1. Nanomaterials embedded in a product matrix that may have a potential to leach from manufactured items (for example, electrical/electronic products, textiles) were set as level 2. Nanomaterials with known use(s) in products available to the consumer (for example, cleaners, paints, personal care products, cosmetics), or intended to be used by or for children, or in food or food packaging materials were assigned as level 3. For a given nanomaterial with multiple uses, the overall use level was determined based on the highest level identified.
Estimating exposure
Taken together, an exposure matrix based on three levels, each for volume and use, was established to identify the overall exposure potential for a given CAS RN (figure 1). A nanomaterial having industrial uses only is placed in Bin 1 if the import/manufacture volume is below 100 000 kg/year. Otherwise, it is in Bin 2. A nanomaterial used in a manufactured item is placed in Bin 2 (if the volume is below 100 000 kg/year) or Bin 3 (if the volume is above 100 000 kg/year). When a consumer related use is identified, it is placed in Bin 3 for the quantity of import/manufacture equal or greater than 100 kg (all 3 levels).
Figure 1: exposure matrix
Long description for figure 1
The above figure depicts a 3 by 3 matrix with the rows representing “use” levels 1, 2, and 3, corresponding to industrial use, manufactured items, and consumer related use, respectively; and the columns depicting “volume” levels 1, 2, and 3, which correspond to 100 to 10 000 kg/year, 10 000 to 100 000 kg/year, and over 100 000 kg/year quantities respectively. The purpose of this matrix is to display how exposure potential for nanomaterials was assigned to one of 3 bins (Bin 1, Bin 2, or Bin 3, corresponding to low, medium, and high exposure potential).
A nanomaterial having industrial uses only is placed in Bin 1 if the import/manufacture volume is greater than 100 kg/year and less than 100 000 kg/year. Otherwise, it is placed in Bin 2.
A nanomaterial used in a manufactured item is placed in Bin 2 if the import/manufacture volume is greater than 100 kg/year and less than 100 000 kg/year, or Bin 3 if the volume is above 100 000 kg/year.
When a consumer related use is identified, it is placed in Bin 3 for the quantity of import/manufacture equal or greater than 100 kg (that is, for all 3 levels of the “volume”).
3.2 Hazard
In considering the potential human health hazard of a nanomaterial, both the physico-chemical properties of a nanomaterial and its toxicity were considered. Wide-ranging sources of information were consulted to inform the development of a hazard profile of each CAS RN, including but not limited to the following:
- peer-reviewed scientific literature (published between 2010 and 2020)
- additional toxicity information submitted with the s.71 survey responses (Canada, 2015a)
- Government of Canada assessments [for example, conducted under the Priority Substances List (PSL) Programme or the CMP]
- international assessments and databases
- OECD WPMN nanomaterial dossiers
- ECHA registration dossiers
- Consumer Product Information Database
- Hazardous Substances Data Bank (HSDB)
- MSDSs
- Global Harmonized System of Classification and Labelling of Chemicals (GHS)
Information about physico-chemical properties, including size, shape, surface properties, and others, can help to identify the potential hazard of a nanomaterial. For example, a high aspect ratio nanomaterial (HARN), is one that is made in a fibrous or wire shape. It is generally recognized that a rigid and biopersistent HARN is likely to be hazardous due to asbestos-like behaviors. Similarly, the presence of a structural alert for toxicity [for example, a U.S. Environmental Protection Agency (EPA) chemical category of concern (EPA, 2010)] in the bulk form of a CAS RN will be indicative of a human health hazard for the substance at the nanoscale at this time.
Following a review of the available hazard information, each of the 53 CAS RNs was assigned into a hazard Bin. Bin 1 was to capture nanomaterials for which the available evidence indicates low toxicity at this time. Based on the best available information, these nanomaterials did not show adverse effects in either classical toxicity tests or alternative test methods, and do not have any of the high or moderate hazard flags identified below. Bin 2 was to contain those nanomaterials for which there was some concern regarding the potential for human health hazard, but, based on professional judgment and weight of evidence, the nanomaterial is not expected to pose a high hazard to human health. These may include nanomaterials for which there is evidence of skin sensitization, eye irritation or for which there are mechanistic data suggesting effects such as cardiovascular or inflammatory effects. Bin 3 was to capture nanomaterials for which there was sufficient evidence that the nanomaterial can cause serious health effects (for example, carcinogenicity, mutagenicity, reproductive/developmental toxicity, neurotoxicity etc.). These may include nanomaterials that contain a structural alert for toxicity based on their bulk form or exist as HARNs. Nanomaterials for which the bulk substance was known to be highly hazardous to human health may also be included in the high hazard bin. The outcomes of this exercise helped to identify the data needs for these nanomaterials with respect to hazard endpoints that are commonly considered in the regulatory risk assessment.
4. Results
The in-commerce list of 53 nanomaterials established from the s.71 survey, as well as results of the triage/data gap analysis of these nanomaterials from a human health perspective, are presented in table 1. Areas where research and/or information gathering was needed to fill in data gaps were identified; this will help to guide and establish targeted research activities and/or information gathering initiatives.
The results of the data gap analysis indicated that information about the properties and availability of discrete forms of each nanomaterial in Canada is largely missing, including size, shape, surface properties, identification of surface modified/treated groups, and other characteristics, if relevant (table 1). For exposure consideration, 22 out of 53 nanomaterials may have sufficient exposure information to characterize exposure. For the remaining 31 nanomaterials, further confirmation of some consumer applications in commerce in Canada is required. The analysis of human health hazard revealed that, for 8 out of 53 nanomaterials, hazard characterization data are available and may be sufficient for hazard characterization. By contrast, several nanomaterials on the list were determined to have limited or no specific data, and require further research or other strategies to fill data needs (for example, read-across). Taken together, these results suggest the need to build a more comprehensive knowledge base of the identified nanomaterials in commerce in Canada.
5. Next steps
In order to conduct a regulatory risk assessment on these DSL nanomaterials, efforts will be made to fill in the data gaps identified in table 1. In addition to ongoing literature search and updating information from the identified sources, various options are to be explored, including:
- seeking information from industry on characterization of each nanomaterial (for example, particle size, shape, surface properties) and some uses in commerce in Canada
- follow up with other regulatory programs on specific uses (for example, cosmetics, natural health products) of nanoscale forms in the Canadian market
- promotion of research to fill specific hazard data gaps and to inform the development of strategies for grouping and read-across, as well as to develop other predictive tools for toxicity of nanomaterials
Development of a regulatory risk assessment framework is underway, to underpin the assessment of these DSL nanomaterials under the CMP.
| CAS RN | Substance name | Data needs Nanomaterial characterization |
Data needs Uses |
Data needs Hazard |
|---|---|---|---|---|
| 471-34-1 | Carbonic acid calcium salt (1:1) | Size, shape, surface properties, and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterials during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on the nanofibrous form The spherical form of this nanomaterial has been shown to have low toxicity. However, this substance can potentially be produced in fibrous form which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard of the fibrous form of this nanomaterial and to define points of departure for risk assessment. This information can be obtained from mammalian toxicity studies (for example, intratracheal or pulmonary instillation studies, short term or repeated dose inhalation studies). In vitro or ex vivo studies, performed with appropriate cultured cells and models, can be used as alternative methods and may be valuable in determining relevant toxicological endpoints as well as mechanisms. |
| 1302-87-0 | Clays | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada to be confirmed. | Toxicity data on nanoscale forms Based on limited available studies on nanoclays, this nanomaterial appears to have low acute oral toxicity, but inconclusive genotoxicity. However, the substance can potentially be produced as nanotubes, which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data on nanoclays are needed to characterize the hazard of the substance in the nanotube form and to define points of departure for risk assessment. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicity information can be obtained from mammalian toxicity studies, such as short-term dermal and oral toxicity, instillation, short term, or repeated dose inhalation toxicity, and genotoxicity. In vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used as important alternative methods in determining relevant toxicological endpoints as well as mechanisms. |
| 1305-62-0 | Calcium hydroxide (Ca(OH)2) | Size, shape, surface properties, and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms Toxicological information on calcium hydroxide nanoparticles is limited. However, bulk calcium hydroxide is a known skin, eye and respiratory tract irritant. More toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the nanomaterial. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal and oral toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1305-78-8 | Calcium oxide (CaO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics in Canada are to be confirmed. | Toxicity data on nanoscale forms No toxicological information is available for calcium oxide nanoparticles. However, bulk calcium oxide is a known skin, eye, digestive- and respiratory- tract irritant. More toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the nanomaterial. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics. Toxicological information can be obtained from mammalian toxicitystudies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1305-79-9 | Calcium peroxide (Ca(O2)) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics in Canada are to be confirmed. | Toxicity data on nanoscale forms No toxicological information is available for calcium peroxide nanoparticles. However, bulk calcium peroxide is a known skin, eye, and respiratory tract irritant. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal exposure, instillation, short term, or repeated dose inhalation exposure, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1306-38-3 | Cerium oxide (CeO2) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | May have sufficient data |
| 1309-37-1 | Iron oxide (Fe2O3) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on particles with various surface coating materials Available studies revealed conflicting toxicity information on iron oxide (Fe2O3) nanoparticles. The toxicity appears to be dependent on the surface properties. Certain iron oxide nanoparticles have been shown to cause moderate repeated dose oral and inhalation toxicity and may have potential reproductive/developmental toxicity, neurotoxicity and genotoxicity. More data from mammalian toxicity and in vitro studies are needed in order to reconcile toxicity data, and clarify the influence of surface coatings on the toxicity of these nanoparticles. |
| 1309-42-8 | Magnesium Hydroxide (Mg(OH)2) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms Toxicological information on magnesium hydroxide nanoparticles is limited. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1309-48-4 | Magnesium oxide (MgO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms Available in vivo genotoxicity and acute oral studies showed that MgO nanoparticles may be genotoxic and cause oxidative stress. These nanoparticles may also be manufactured as nanofibres, which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to define points of departure for risk assessment of the nanomaterial, especially when it is in the nanofibre form. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1313-13-9 | Manganese oxide (MnO2) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | May have sufficient data |
| 1313-99-1 | Nickel oxide (NiO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in plastics and lubricant additives in Canada are to be confirmed. | May have sufficient data |
| 1314-13-2 | Zinc oxide (ZnO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | May have sufficient data |
| 1314-23-4 | Zirconium oxide (ZrO2) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, drug delivery, paints and coatings in Canada are to be confirmed. | Toxicity data on nanofibre form and reconciliation of genotoxicity Zirconium oxide nanoparticles exhibit low toxicity following repeat dose oral (28-day) and inhalation (5-day) exposure. Reports of in vitro clastogenicity are mixed; however, bulk zirconium oxide is not genotoxic or clastogenic. ZrO2 can be engineered as nanotubes, which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to reconcile information on genotoxicity and define points of departure for risk assessment of the substance in the nanotube form. This information can be obtained from mammalian toxicity studies, such as intratracheal or pulmonary instillation, short term or repeated dose inhalation, and genotoxicity studies. In vitro or ex vivo studies, performed with appropriate cultured cells and models, can be used as alternative methods and may be valuable in determining relevant toxicological endpoints as well as mechanisms. |
| 1317-34-6 | Manganese oxide (Mn2O3) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms The few in vitro studies on Mn2O3 available from literature searches, report cytotoxicity and oxidative stress in test cell lines. Bulk Mn2O3 may be a neurotoxic substance. Mn2O3 nanoparticles may also be engineered as nanowires, which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in nanoscale forms, including nanofibres. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1317-38-0 | Copper oxide (CuO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, paints and coatings, medical application in Canada are to be confirmed. | May have sufficient data |
| 1317-61-9 | Iron oxide (Fe3O4) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on particles with various surface coating materials Available in vivo studies suggested low acute oral and inhalation toxicity, but high repeated dose inhalation toxicity, and potential genotoxicity and developmental toxicity. The in vitro studies showed mixed results. The toxicity may be dependent on the surface properties. More toxicity data from mammalian toxicity and in vitro studies are needed to clarify the influence of surface coatings on the toxicity of these nanoparticles. |
| 1327-36-2 | Aluminatesilicate | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms No toxicological information is available for aluminate silicate nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from in mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1332-37-2 | Iron oxide | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscal uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms Based on information from iron oxides in general as well as for Fe2O3, Fe3O4 and FeO, iron oxide (CAS RN 1332-37-2) is anticipated to have low toxicity following acute oral and inhalation exposure, but high toxicity following repeated dose inhalation exposure. There is also evidence that it may be genotoxic, neurotoxic, and (depending on surface coating) result in developmental toxicity. Repeated (occupational) exposure to bulk iron oxide may result in siderosis (also known as welder’s lung); however, this condition is reversible when exposure is discontinued. Iron oxide is not anticipated to be an eye or skin irritant, nor it is it anticipated to be a skin sensitizer. The nanoparticles may potentially be manufactured as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1333-84-2 | Aluminum oxide, hydrate | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for aluminum oxide hydrate nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1344-43-0 | Manganese oxide (MnO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms There are a few in vitro studies available for MnO nanoparticles, suggesting they may cause oxidative stress. The bulk form is a neurotoxic substance. These nanoparticles may be manufactured as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. These data can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 1344-28-1 | Aluminum oxide (Al2O3) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms Available in vivo studies (13-day repeated dose oral and acute/sublethal) suggested potential liver, kidney, and immune toxicity as well as genotoxicity. The nanomaterial can be produced as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to define points of departure for risk assessment risk assessment of the substance in the nanoscale forms, including nanofibres. This toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation toxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can be useful in determining relevant toxicological endpoints as well as mechanisms. |
| 1345-25-1 | Iron oxide (FeO) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, paints and coatings in Canada are to be confirmed. | Toxicity data on nanoscale forms Toxicological information on iron monoxide (FeO) nanoparticles is limited. The nanomaterial can be made as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics, paint and coatings. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 7439-89-6 | Iron | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, natural health products, and spray paints in Canada are to be confirmed. | Toxicity data on nanoscale forms Toxicological information on elemental iron nanoparticles is limited. The nanomaterial may be manufactured as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics, natural health products, and spray paints. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 7440-22-4 | Silver | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | May have sufficient data |
| 7631-86-9 | Silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Read-across/grouping justification Available toxicity study on certain forms silica nanoparticles showed high repeated dose oral and inhalation toxicity. There is a concern that silica nanoparticles induce genotoxicy, immunotoxicy, and cardiovascular and neurological toxicity. More research is required to determine whether the toxicity profiles of the different silica nanoparticles of different CAS RNs are comparable, and thus whether read-across can be employed in the assessments. |
| 7758-87-4 | Phosphoric acid, calcium salt (2:3) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for calcium phosphate nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 7778-18-9 | Sulfuric acid, calcium salt (1:1) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms No toxicological information is available for calcium sulphate nanoparticles. Bulk calcium sulphate is generally considered non-toxic, but may cause respiratory irritation following inhalation exposure. Calcium sulphate nanomaterials can be engineered in fibrous form which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 9004-32-4 | Cellulose, carboxymethyl ether, sodium salt | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics and natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, carboxymethyl ether, sodium nanoparticles. The substance can be engineered in fibrous form which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-34-6 | Cellulose | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification Nanocellulose has been shown to induce cytotoxicity, inflammation, oxidative stress, and may be genotoxic. A repeated inhalation toxicity study showed that nanocellulose induced pulmonary inflammation and possible effects on male reproduction. The substance can be engineered as nanofibres which may have major toxicological significance due to asbestos-like behaviors, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to reconcile with those from available studies and to define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-36-8 | Cellulose, acetate butanoate | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in natural heath products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, acetate butanoate nanoparticles. The substance can be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-39-1 | Cellulose, acetate propanoate | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, acetate propanoate nanoparticles. The substance, as a form of nanocellulose, can be engineered as nanofibres which be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in food additives. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-57-3 | Cellulose, ethyl ether | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, ethyl ether nanoparticles. The substance can be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-58-4 | Cellulose, ethyl 2-hydroxyethyl ether | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, ethyl 2-hydroxyethyl ether nanoparticles. The substance can be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-62-0 | Cellulose, 2-hydroxyethyl ether | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, natural health products, cleaning products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for hydroxyethylcellulose nanoparticles. It may also exist as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define point of departures for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products and cleaning products. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-65-3 | Cellulose, 2-hydroxypropyl methyl ether | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in natural health products in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, 2-hydroxypropyl methyl ether nanoparticles. The substance can be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in natural health products. Toxicological information can be obtained from in vivo studies such as short-term oral and dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9004-70-0 | Cellulose, nitrate | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for the substance at the nanoscale; however, it can be engineered as nanofibres which may be more toxic due to asbestos-like behaviors, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 9032-42-2 | Cellulose, 2-hydroxyethyl methyl ether | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics in Canada are to be confirmed. | Toxicity data on nanoscale forms and grouping/read across justification No toxicological information is available for cellulose, 2-hydroxyethyl methyl ether nanoparticles. The substance can be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Data requirement also considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. More research is required to determine whether celluloses of different CAS RNs can be grouped together on basis of similarities on chemical composition and other physico-chemcial properties, and thus whether read-across can be employed in the assessments. |
| 12004-35-2 | Aluminum nickel oxide (Al2NiO4) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for aluminum nickel oxide. This substance, however, contains nickel, which is identified as a category of concern by the U.S. EPA. Nickel oxides were also found toxic under a PSL1 assessment under CEPA section 64c of CEPA. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 13463-67-7 | Titanium oxide (TiO2) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | May have sufficient data |
| 14059-33-7 | Bismuth vanadium oxide (BiVO4) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No information on the hazard of bismuth vanadium oxide nanoparticles was found in the publicly available literature; however, information collected from s.71 survey suggests that the substance may have high repeat dose inhalation toxicity. More toxicity data are needed to reconcile the available data and to characterize the hazard for risk assessment of the nanomaterial. Further toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 20344-49-4 | Iron hydroxide oxide (Fe(OH)O) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics, natural health products, adhesives in Canada are to be confirmed. | Toxicity data on nanoscale forms Very little toxicity data could be found for iron oxide hydroxide nanoparticles. Data available on the EHCA dossiers suggest low toxicity following acute oral exposure, but moderate toxicity following repeated dose inhalation exposure. The substance can also be engineered as nanofibres which be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are needed to reconcile the available data and to characterize the hazard for risk assessment of the nanomaterial when it is in the nanofibre form. This data requirement considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics, natural health products, adhesives, and food manufacturing. Further toxicological information can be obtained from mammalian toxicity studies such as acute dermal toxicity, additional inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 24623-77-6 | Aluminum hydroxide oxide (Al(OH)O) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoacale uses in cosmetics and cleaning products in Canada are to be confirmed. | Toxicity data on nanoscale forms Very little toxicity data could be found for Aluminum hydroxide oxide nanoparticles. A single study showed inflammation in rats following subchronic inhalation. More toxicity data are needed to reconcile the available data and to characterize the hazard for risk assessment of the nanomaterial. This data requirement considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics and cleaning products. Further toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, additional inhalation toxicity, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 63231-67-4 | Silica gel | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Read-across/grouping justification There are a limited number of studies on silica gel that showed potential genotoxicity, immunological, and cardiovascular effects induced by the nanoparticles. However, more toxicological information is available for other forms of silica nanoparticles with different CAS RNs. More research is required to determine whether the toxicity profiles of the different silica nanoparticles of different CAS RNs are comparable, and thus whether grouping/read-across can be employed in the assessments. |
| 67762-90-7 | Siloxanes and Silicones, di-Me, reaction products with silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for this nanomaterial. The bulk form has been shown to cause adverse effects in the lung of rats following 4-week intermittent inhalation exposure. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 68187-51-9a and 12063-19-3 | Unspecified (predominantly iron zinc oxide (Fe2ZnO4)) | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in cosmetics in Canada are to be confirmed. | Toxicity data on nanoscale forms Toxicological information on iron zinc oxide nanoparticles is limited. This substance may be manufactured in nanofibre form which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. This considers relevant routes of exposure from the potential use of the nanoscale forms in cosmetics. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 68610-92-4 | cellulose, ether with α-[2-hydroxy-3-(trimethylammonio)propyl]-ω-hydroxypoly(oxy-1,2-ethanediyl), chloride | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for cellulose, ether with α-[2-hydroxy-3(trimethylammonio)propyl]-ω-hydroxypoly(oxy-1,2-ethanediyl) chloride nanoparticles. However, the substance contains a quaternary ammonium moiety which has potential to act as a cationic surfactant and biocide. In addition, the substance can be engineered in nanofibre form which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms, including nanofibres. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 68611-44-9 | Silane, dichlorodimethyl-, reaction products with silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | May have sufficient data |
| 68909-20-6 | Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for this modified silica nanomaterial. Toxicity data for unmodified silica nanoparticle are available, but there is inadequate scientific justification to support read-across from unmodified to modified silica nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 68937-51-9 | Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, reaction products with ammonia, octamethylcyclotetrasiloxane and silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for this modified silica nanomaterial. Toxicity data for unmodified silica nanoparticle are available, but there is inadequate scientific justification to support read-across from unmodified to modified silica nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 68988-89-6 | Silica, [(ethenyldimethylsilyl)oxy]- and [(trimethylsilyl)oxy]-modified | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Toxicity data on nanoscale forms No toxicological information is available for this modified silica nanomaterial. Toxicity data for unmodified silica nanoparticle are available, but there is inadequate scientific justification to support read-across from unmodified to modified silica nanoparticles. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. This considers relevant routes of exposure from the potential use of the nanoscale forms in food contact. Toxicological information can be obtained from mammalian toxicity studies such as short-term oral and dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 69012-64-2 | Fumes, silica | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Nanoscale uses in paints and coatings, adhesives in Canada are to be confirmed. | Toxicity data on nanoscale forms No toxicological information is available for silica fume nanoparticles; however, bulk silica fume is a respiratory irritant and may cause lung damage following prolonged or repeated exposure. Toxicity data are needed to characterize the hazard and define points of departure for risk assessment of the substance in the nanoscale forms. This considers relevant routes of exposure from the potential use of the nanoscale forms in paints and coatings, and adhesives. Toxicological information can be obtained from mammalian toxicity studies such as short-term dermal toxicity, instillation, short term, or repeated dose inhalation studies, and genotoxicity. Alternatively, in vitro or ex vivo studies, performed with appropriate cultured cells and models, can also be used in determining relevant toxicological endpoints as well as mechanisms. |
| 112926-00-8 | Silica gel, pptd., cryst.-free | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Read-across/grouping justification Available in vitro data suggest this nanomaterial (precipitated silica) may induce genotoxicity, immunotoxicity, cardiovascular effects. Studies on laboratory animals suggest the nanomaterial has low acute and repeated oral and inhalation toxicity. This nanomaterial can potentially be engineered as nanofibres which may be more toxic due to asbestos-like properties, including high aspect ratio, rigidity, and biopersistence. More toxicity data are required for reconciling with the findings from the available studies and for assessing toxicity of the nanomaterial when it is engineered in the nanofibre form. In addition, more research is needed to determine whether the toxicity profiles of other silica nanoparticles with different CAS RNs are comparable and whether grouping/read-across can be employed in the assessments. |
| 112945-52-5 | Silica, amorphous, fumed, cryst.-free | Size, shape, surface properties and others if available Physicochemical properties including size, shape, and surface properties (surface area, surface chemistry, surface roughness, etc.) are key indicators of nanomaterial hazard. In addition, these properties are also important in determining the fate of a nanomaterial during its life cycle. |
Representative information may be available for exposure analysis. | Read-across/grouping justification Available data suggest that pyrogenic silica may be genotoxic and immunotoxic. Studies in laboratory animals showed that the nanomaterial has high acute inhalation but low repeated dose oral and inhalation toxicity. More toxicity data are required for reconciling with the findings from the available studies. In addition, more research is needed to determine whether the toxicity profiles of other silica nanoparticles with different CAS RNs are comparable and whether grouping/read-across can be employed in the assessments. |
a Although CAS RN 68187-51-9 was not on the list of 206 substances requested on the s.71 survey, it was also recognized as CAS RN 12063-19-3 which was surveyed and has been confirmed in commerce at the nanoscale.
6. References
Canada. 2015a. Notice with respect to certain nanomaterials in Canadian commerce.
Canada. 2016. Consultation document: prioritization approach for nanoscale forms of substances on the Domestic Substances List.
[ECCC] Environment and Climate Change Canada. 2017. Consultation Document: Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List.
[EPA] U.S. Environmental Protection Agency. 2010. TSCA New Chemicals Program (NCP) Chemical Categories.
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