New substances: risk assessment summary, new substances notification 18630
Official Title: New Substances Notification No. 18630: 2-Imidazolidinone, 1-(2-hydroxyethyl)-
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.
Substance identity
The chemical, 2-Imidazolidinone, 1-(2-hydroxyethyl)- (Chemical Abstracts Service Registry No. 3699-54-5), can be classified as a urea, imidazolidinone.
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 inks, paints and coatings. Potential uses may include personal care products.
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 expected half-life in water (<182 days). The substance is not expected to bioaccumulate based on its very low octanol-water partition coefficient (logKow ≤0) and low predicted bioconcentration and bioaccumulation factors (<250 L/kg).
Ecological assessment
Based on the available hazard information on the substance and surrogate data on 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) and is also expected to have low chronic toxicity in aquatic organisms. A predicted no-effect concentration was not calculated given the low potential for ecological risk.
The notified activities in Canada were assessed to estimate the environmental exposure potential of the substance throughout its life cycle. Environmental exposure from the notified activities is expected to be negligible due to product handling and disposal practices. A predicted environmental concentration for notified activities was not estimated given the low potential for ecological risk.
Based on the low ecotoxicity of the substance as well as the negligible expected environmental exposure, 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 low potential for subchronic toxicity and reproductive/developmental toxicity following repeat oral doses in mammalian test animals (28-day no-observed-effect level >1000 mg/kg-bw/d). It is not a skin sensitizer. It is not mutagenic or clastogenic in vitro. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used in inks, coatings, and paints, direct dermal contact may occur during application of consumer paints. However, dermal uptake and systemic distribution is expected to be low given that the substance will be present in end-use products in very low concentrations (≤0.01% in paints), and given its very low octanol-water partition coefficient (log Kow ≤0). Indirect exposure of the general population from environmental media such as drinking water is expected to be negligible.
Based on its structure, the substance could potentially be used in personal care products. Although there is an increased exposure potential via direct dermal exposure of the general population from these potential applications, given the very low octanol-water partition coefficient of the substance, dermal absorption and systemic exposure is not expected.
Based on the low potential for dermal uptake, negligible indirect exposure and low toxicity, 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.
Assessment conclusion
When the substance is used as notified or for other identified potential uses, it is not suspected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.
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 the Hazardous Products Regulations for products intended for workplace use.