New substances: risk assessment summary, new substances notification 21110
Official title: New Substances Notification 21110: Fatty acids, unsatd., dimers, polymers with bisphenol A, cashew nutshell liq., epichlorohydrin, ethylenediamine, formaldehyde, fatty acids and polyethylenepolyamine (Confidential Accession Number 19598-6)
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 fatty acids, unsatd., dimers, polymers with bisphenol A, cashew nutshellliq., epichlorohydrin, ethylenediamine, formaldehyde, fatty acids and polyethylenepolyamine (Confidential Accession Number 19598-6). The substance does not meet the Reduced Regulatory Requirements criteria according to the New Substances Notification Regulations (Chemicals and Polymers) because it contains cationic amine and unsubstituted positions ortho or para to phenolic hydroxyl groups.
Notified and potential uses
The substance is proposed to be imported into Canada in quantities greater than 10 000 kg/yr for the notified use as a component in industrial coating systems. Potential uses may include commercial and consumer coating systems.
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 is expected to be persistent in soil and sediment based on low water extractability, and lack of environmentally degradable groups. The substance is not expected to bioaccumulate based on its high molecular weight, which will limit its ability to cross biological membranes.
Environmental risk assessment
Based on the low water extractability (< 2%), the substance is expected to have low bioavailability. Therefore, a predicted no-effect concentration was not calculated given the low potential for hazard to the environment.
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 by release of the substance to water at low rates. A predicted environmental concentration was not calculated due to the low potential for environmental exposure. No potential activities that 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 harm to the environment in Canada.
Human health risk assessment
No mammalian toxicity data are available for the substance. The substance contains unsubstituted positions ortho or para to phenolic hydroxyl functional groups which are moderately reactive and a structural feature known to be associated with adverse human health effects.
When the notified substance is used industrially in fast dry epoxy coatings, the general public may come into contact with end-use products containing the substance; however, direct exposure is not expected because the substance will be cured into a stable matrix and will be unavailable for uptake. Potential uses of the substance include commercial and consumer epoxy coatings, where direct exposure of the general population is expected to be mainly by contact with the skin. When the substance is used commercially, direct exposure of the general population is expected to be at levels that do not pose a concern, similar to that of the notified use. When the substance is used in Do-It-Yourself consumer products, consumers may come in contact with the substance; however, exposure will be limited by the frequency and duration of use, the low concentration of the substance in the products, and the limited ability of the substance to cross biological membranes. Indirect exposure of the general population from environmental media such as drinking water is expected to be at low levels given the low potential for environmental release.
Based on the low potential for exposure, 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.
The assumptions made in the assessment are considered to be adequately protective for the general population as well as for subpopulations who may be more susceptible or highly exposed.
Assessment conclusion
When the substance is used as notified or for other identified potential activities, it is not expected to be harmful to human health or the environment according to the criteria under section 64 of the Act.
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 the workplace.