New substances: risk assessment summary, new substances notification 19075
Official Title: Carbamic acid, N-[3-[poly(substituted alkyl)amino]propyl]-, 2-hydroxy-1-methylethyl ester, polymer with 2-hydroxypropyl N-[3-[poly(substituted alkyl)amino]propyl]carbamate and polymethylenepolyphenylene isocyanate, 2-propoxyethanol-blocked
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 carbamic acid, N-[3-[poly(substituted alkyl)amino]propyl]-, 2-hydroxy-1-methylethyl ester, polymer with 2-hydroxypropyl N-[3-[poly(substituted alkyl]amino]propyl]carbamate and polymethylenepolyphenylene isocyanate, 2-propoxyethanol-blocked (Confidential Accession No. 19371-9). The substance does not meet the Reduced Regulatory Requirements criteria according to the New Substances Notification Regulations (Chemicals and Polymers) because it has a high percentage of low molecular weight components and contains potentially cationic amines.
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. Potential uses may include use in industrial/commercial adhesives and inks.
Environmental fate and behaviour
Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to soil and sediment. The substance is expected to be persistent in soil and sediment because it does not contain any functional groups that are susceptible to degradation. The substance is not expected to bioaccumulate based on its low predicted bioaccumulation and bioconcentration factors (<250 L/kg).
Ecological assessment
Based on predicted ecotoxicity data, the substance is expected to have low acute toxicity in aquatic invertebrates (median lethal concentration (LC50) >100 mg/L), moderate acute toxicity in fish (LC50 1-100 mg/L) and moderate chronic toxicity in algae (median effective concentration 1-100 mg/L). Using the LC50 from the most sensitive organism (fish) and by applying an assessment factor of 100 to address acute to chronic extrapolation and species sensitivity variation, the predicted no-effect concentration (PNEC) was calculated to be between 0.1 and 1 mg/L.
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 activities such as cleaning of transportation vessels is not expected given the low water extractability of the substance. For potential activities such as manufacturing, environmental exposure is expected to be similar to that of the notified use. A predicted environmental concentration was not calculated due to the low potential for environmental exposure.
Based on the low potential for environmental exposure and low bioavailability, the substance is unlikely to cause ecological harm in Canada.
Human health assessment
Based on the hazard information, the substance has a low potential for acute toxicity by the oral route of exposure (median lethal dose >2000 mg/kg body weight).
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 cured and will be unavailable for uptake. Indirect exposure of the general population from environmental media such as drinking water is expected to be low as significant environmental releases are not expected and widespread dispersal of the substance is not expected given is low water extractability. If the substance is used industrially/commercially in adhesives and inks, direct exposure of the general population is not expected due to the industrial/commercial nature of the use. Indirect exposure of the general population is expected to be similar to that of the notified use.
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.
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 Hazardous Products Regulations for products intended for the workplace.