New substances: risk assessment summary, new substances notification 20198
Official title: New Substances Notification 20198: Formaldehyde, polymer with N1-(2-aminoethyl)-N2-[2-[(2-aminoethyl)amino]ethyl]-1,2-ethanediamine, alkane bis oxymethyleneoxirane, 4,4'-(1-methylethylidene)bis[phenol] and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane], reaction products with Bu glycidyl ether and 1-[[2-[(2-aminoethyl)amino]ethyl]amino]-3-phenoxy-2-propanol, acetates (salts) (Confidential Accession Number 13804-7)
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 determined that the substance is anticipated to enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
In order to ensure that the substance does not cause harm to the Canadian environment or human health, its import is authorized subject to conditions as described in Ministerial Condition No. 20198 published in the Canada Gazette Part I, Vol. 154, No. 4 on January 25, 2020.
Substance identity
The notified polymer is formaldehyde, polymer with N1-(2-aminoethyl)-N2-[2-[(2-aminoethyl)amino]ethyl]-1,2-ethanediamine, alkane bis oxymethyleneoxirane, 4,4'-(1-methylethylidene)bis[phenol] and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane], reaction products with Bu glycidyl ether and 1-[[2-[(2-aminoethyl)amino]ethyl]amino]-3-phenoxy-2-propanol, acetates (salts) (Confidential Accession No. 13804-7). The substance does not meet the Reduced Regulatory Requirements criteria according to the New Substances Notification Regulations (Chemicals and Polymers) because its number average molecular weight is less than 1000 daltons and it contains a high percentage of low molecular weight components. Additionally, it contains potentially cationic amine groups.
Notified and potential uses
The substance is proposed to be imported into Canada in quantities greater than 1000 kg/yr for the notified use in industrial coatings. Potential uses may include consumer coatings.
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 sediments. The substance is expected to be persistent in these compartments because it does not contain any functional groups that are susceptible to hydrolysis and biodegradation. The substance is not expected to bioaccumulate based on its very low octanol-water partitioning coefficient (log Kow ≤ 0).
Ecological assessment
Based on the available hazard information, the substance has moderate acute toxicity to aquatic invertebrates (median effective concentration (EC50) >1 mg/L), low to moderate acute toxicity to fish (median lethal concentration between 1-100 mg/L) and low to high toxicity to algae (EC50 <1-100 mg/L) under environmental conditions when mitigated by dissolved organic carbon. Using the EC50 from the most sensitive organism (aquatic algae) and by applying an assessment factor of 50 to account for acute to chronic extrapolation, species sensitivity, and mode of action, the predicted no-effect concentration (PNEC) was calculated to be in the range of 0.001 to 0.01 mg/L, which was used to estimate the 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 by release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 0.001 to 0.01 mg/L.
Comparing the PEC with the PNEC, the ratio is less than 1. This, along with other lines of evidence including environmental fate, hazard, and exposure, indicates that the substance is unlikely to cause ecological harm in Canada.
Human health assessment
Based on the available hazard information, the substance has a low to moderate acute toxicity by the oral and dermal routes (median lethal dose >300 mg/kg body weight). It is an extreme dermal sensitizer in the guinea pig maximization test (81-100% response) and a weak dermal sensitizer in the local lymph node assay (estimated concentration required to produce a stimulation index of 3 >10%).
When the notified substance is used in paints and coatings industrially or commercially, 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 at low levels given the low potential for release to the environment.
Potential uses of the substance include use in consumer paints, coatings, sealants, binders and adhesives, where direct exposure of the general population is expected to be mainly by contact with the skin at moderate to high levels. Potential uses of the substance also include use in industrial and commercial sealants, binders and adhesives, where direct and indirect exposure of the general population is expected to be at levels that do not pose a concern, similar to that of the notified use.
Based on the potential for significant dermal exposure combined with the dermal sensitization effects, the substance is anticipated to be harmful to human health. These risks are associated with use of the substance in sealants, binders, adhesives, and in paints and coatings for consumer use.
Assessment conclusion
The substance is suspected to constitute a danger to human health according to the criteria under paragraph 64 (c), but is not suspected to have a harmful effect on the environment according to the criteria under paragraph 64 (a) or (b) of the Act.
Due to the identified risk to human health related to dermal sensitization, a ministerial condition was issued to restrict the manner in which the notifier may manufacture or import the substance with conditions on its use in order to mitigate these potential risks. Ministerial Condition No. 20198 was published in the Canada Gazette Part I, Vol. 154, No. 4 on January 25, 2020.
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.