New substances: significant new activities 18936
Official Title: Significant New Activity No. 18936: 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-
Regulatory decisions
Under the provisions for Substances and Activities New to Canada in Part 5 of the Canadian Environmental Protection Act, 1999 (CEPA), and pursuant to section 83 of the Act, the Minister of the Environment and the Minister of Health have assessed information in respect of the substance, and have determined that it is not anticipated to enter 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, constitute or may constitute a danger to the environment on which life depends, or constitute or may constitute a danger in Canada to human life or health.
However, a significant new activity (SNAc) order was adopted based on uncertainties regarding potential human health impacts of the substance in relation to certain new activities. SNAc No. 18936 outlines information requirements for those activities and was published in the Canada Gazette Part II, Vol. 152, No. 7 April 4, 2018. Notification is required prior to commencement of those activities identified as a potential risk to ensure the substance undergoes further assessment and risk management consideration.
Substance identity
The chemical, 2-propanol, 1-[bis(2-hydroxyethyl)amino]- (Chemical Abstracts Service Registry No. 6712‑98‑7), can be classified as an alkanolamine.
Notified and potential activities
The substance is proposed to be manufactured in and/or imported into Canada in quantities greater than 10 000 kg/yr for use in the construction industry. The potential use of the substance in consumer products, such as household cleaners/detergents and personal care products, has also been assessed and the available information was determined to be inadequate to assess activities under the conditions of these potential uses. Other potential uses may include a range of industrial uses.
Environmental fate and behaviour
Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to water. The substance is not expected to be persistent in water based on its high biodegradability (>85%). The substance is not expected to bioaccumulate based on its modelled low bioconcentration and bioaccumulation factors (<250 L/kg).
Ecological assessment
Based on the available hazard information on the substance and structurally related chemicals, the substance has low acute toxicity in fish, aquatic invertebrates and algae (median lethal concentration and median effective concentration >100 mg/L). A predicted no-effect concentration was not calculated given the low potential for ecological risk.
The notified and other potential activities in Canada were assessed to estimate the environmental exposure potential of the substance throughout its life cycle. Environmental exposure from the notified activity is expected to be mainly from the cleaning of transportation vessels by release of the substance to water; however, environmental concern is expected to be low. The substance is expected to be effectively removed at wastewater treatment plants due to its high biodegradability (>85%). The substance could also be used in a wide variety of potential applications including in household cleaners/detergents, personal care products and a range of industrial uses. Given the low ecotoxicity of the notified substance, environmental concentrations resulting from potential uses are not expected to result in adverse effects to aquatic organisms. A predicted environmental concentration for notified and potential activities was not estimated given the low potential for ecological risk.
Based on the low potential for environmental exposure and the low ecotoxicity to aquatic organisms, the substance is unlikely to cause ecological harm in Canada.
Human health assessment
Based on the available hazard information, the substance has a low potential for acute toxicity by the oral and dermal routes of exposure (median lethal dose >2000 mg/kg body weight) and a moderate potential for subchronic toxicity following repeat oral doses in mammalian test animals (28-day no-observed-adverse-effect level (NOAEL) 30-300 mg/kg-bw/d). The substance has a high potential for developmental toxicity following repeat oral doses in mammalian test animals (NOAEL 50-250 mg/kg-bw/d). It is not a skin sensitizer (0-8% response (guinea pig maximization test scale)). It is not mutagenic or clastogenic in vitro. Therefore, the substance is unlikely to cause genetic damage. A provisional tolerable daily intake (PTDI) for the substance was determined to be 0.1-1 mg/kg-bw/d based on the NOAEL from the repeated-dose developmental oral toxicity test with mammalian test animals.
When the notified substance is used in the construction industry, the substance is intended for industrial use only and direct exposure of the general population is not expected. Members of the general population may come into contact with end-use products containing the substance mainly by contact with the skin. However, direct exposure is not expected because the substance will be present in low concentrations (<0.1%) and chemically reacted into a stable matrix once cured, making it unavailable for uptake. Indirect exposure of the general population from environmental media such as drinking water is expected to be at levels of 0.00001-0.001 mg/kg-bw/d. However, if the substance is used in personal care products or household cleaners, an increased direct exposure potential may exist, mainly by contact with skin. The direct exposure of the general population from these potential uses is conservatively estimated to be 10-100 mg/kg/bw/d (acute) and 1-10 mg/kg/bw/d (chronic) from its use in household cleaners assuming 50% dermal absorption. The actual exposure is expected to be significantly less since dermal uptake is expected to be limited due to the very low octanol-water partition coefficient (logKow ≤0) of the substance.
Based on the low potential for direct or indirect exposure of the general population for the notified use, the substance is not likely to pose a significant health risk to the general population, and is therefore unlikely to be harmful to human health.
However, based on a comparison of the PTDI with the increased expected dermal exposure, the potential use of the substance in household cleaners and personal care products may result in the substance becoming harmful to human health. Consequently, more information is necessary to better characterize potential health risks.
Other considerations
The United States Environmental Protection Agency has issued a Significant New Use Rule on the substance due to its structural similarity to triethanolamine, which is known to be of concern for human health.
Assessment conclusion
When the substance is used as notified, it is not suspected to be harmful to human health or environment according to the criteria under section 64 of CEPA. However, it is suspected that a significant new activity in relation to the substance may result in the substance meeting those criteria.
Due to the potential risk to the general population of developmental toxicity if the substance is used in personal care products or household cleaners, a SNAc notice was issued to obtain information to ensure that the substance, in relation to these potential activities, undergoes further assessment before such activities can be undertaken. SNAc Order No. 18936 was published in the Canada Gazette Part II, Vol. 152, No. 7 April 4, 2018.
A conclusion under CEPA, on this substance, is not relevant to, nor does it preclude an assessment against the hazard criteria for Workplace Hazardous Materials Information System that are specified in the Controlled Products Regulations or Hazardous Products Regulations for products intended for the workplace.