New substances: risk assessment summary, new substances notification 20790
Official title: New Substances Notification 20790: Formic acid, compds. with bisphenol A-carbomonocyclicamine-epichlorohydrin polymer-hydrolyzed N1-(1,3-dimethylbutylidene)-N2-[2-[(1,3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-2-(methylamino)ethanol reaction products (Confidential Accession Number 19547-5)
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 formic acid, compds. with bisphenol A-carbomonocyclicamine-epichlorohydrin polymer-hydrolyzed N1-(1,3-dimethylbutylidene)-N2-[2-[(1,3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-2-(methylamino)ethanol reaction products (Confidential Accession Number 19547-5). 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 groups.
Notified and potential uses
The substance is proposed to be imported into Canada in quantities greater than 50 000 kg/yr for the notified use in automotive coatings. No other uses 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 is expected to be persistent in these compartments because it is not susceptible to environmental hydrolysis and biodegradation. 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 available hazard information, the substance has low acute toxicity to fish and aquatic invertebrates (median lethal loading rate > 100 mg/L), and is expected to have moderate acute toxicity to algae (median effective loading rate [EL50] > 1 mg/L). Using the EL50, from the most sensitive organism (algae) and by applying an assessment factor of 50 to account for acute to chronic extrapolation, species sensitivity variation and mode of action, the predicted no-effect concentration (PNEC) was calculated to be in the range of 0.01 to 0.1 mg/L, which was used to estimate the risk to the environment.
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. For potential activities such as manufacturing, environmental exposure is expected to be mainly from release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 0.01 to 0.1 mg/L, with the exact value being below the PNEC value.
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 harm to the environment in Canada.
Human health risk assessment
Based on the available hazard information, the substance has low acute toxicity by the oral route (median lethal dose > 2000 mg/kg body weight). It is a weak dermal sensitizer (estimated concentration > 10% required to produce a stimulation index of 1.6 in a local lymph node assay). It is not mutagenic in vitro. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used in automotive coatings, direct exposure of the general population is not expected due to the industrial nature of the use. Indirect exposure of the general population from environmental media is not expected given the specialized industrial use of the substance, which results in little or no release to the environment. No potential uses that could significantly increase human health risks compared to the notified uses were identified.
Based on the low toxicity and 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, 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.