New substances: risk assessment summary, new substances notification 19270
Official title: New Substances Notification No. 19270: 1,3-Dioxolan-2-one, polymer with 1,4-butanediol and 1,6-hexandiol (Chemical Abstracts Service No. 149295-53-4)
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 notified polymer is 1,3-dioxolan-2-one, polymer with 1,4-butanediol and 1,6-hexandiol (Chemical Abstracts Service Registry NumberFootnote 1 149295-53-4). The substance does not meet the Reduced Regulatory Requirements criteria according to the New Substances Notification Regulations (Chemicals and Polymers) because it has a number average molecular weight less than 1000 daltons.
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 the notified use in industrial coatings. No other activities are anticipated in Canada.
Environmental fate and behaviour
Based on its physical and chemical properties, if the substance is released to the environment, it will tend to partition to soil and sediment. The substance and its hydrolysis products are not expected to be persistent in these compartments based on high to very high ready biodegradation (>60% at 28 days). The substance is not expected to bioaccumulate based on its susceptibility to hydrolytic and biological degradation.
Ecological assessment
Based on the available hazard information, the substance has low chronic toxicity in algae (no adverse effects observed in saturated solutions). A predicted no-effect concentration was not calculated given the low potential for ecological hazard.
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 activity is not expected as the substance will be fully consumed during use and limited release is expected from solvent-based cleaning. A predicted environmental concentration was not calculated due to the low potential for environmental exposure. No potential activities which could significantly increase environmental risks compared to those notified were identified.
Based on the low potential for ecotoxicity and 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 acute toxicity by the oral route (median lethal dose >2000 mg/kg body weight). The substance does not contain structural features associated with adverse human health effects.
When the notified substance is used in industrial coatings, consumers may come into contact with end-use products containing the substance; however, direct exposure is not expected because the substance will be chemically reacted into a stable matrix once the product is cured and will be unavailable for uptake. Indirect exposure of the general population from environmental media such as drinking water is expected to be negligible because no environmental releases are expected. No potential uses which could significantly increase human health risks compared to the notified uses were identified.
Based on the low potential for exposure and absence of structural features associated with adverse human health effects, 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, it is not expected 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 Hazardous Products Regulations for products intended for the workplace.