New substances: risk assessment summary, new substances notification 21196
Official title: New Substances Notification 21196: 1,2-Ethanediamine, N1,N2-dimethyl-N1-(1-methylethyl)-N2-[2-[methyl(1-methylethyl)amino]ethyl]- (Chemical Abstracts Service Registry Number 1042950-30-0)
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 chemical is 1,2-ethanediamine, N1,N2-dimethyl-N1-(1-methylethyl)-N2-[2-[methyl(1-methylethyl)amino]ethyl]- (Chemical Abstracts Service Registry NumberFootnote 1 1042950-30-0).
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 in polyurethane foam for industrial and commercial applications. Potential uses may include manufacturing and similar industrial applications.
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 water with some binding potential to soil and sediment. The notified substance is expected to be persistent in these compartments based on its very long half-life in these compartments (> 180 days in water and soil, > 365 days in sediment) and very low biodegradability (≤ 10% over 28 days). The substance is not expected to bioaccumulate based on low predicted bioaccumulation and bioconcentration factors (< 250 L/kg).
Environmental risk assessment
Based on the available hazard information, the substance is expected to have low acute toxicity to fish, and moderate toxicity to aquatic invertebrates and algae (median lethal concentration and median effective concentration [EC50] 1 to 100 mg/L). Using the EC50 from the most sensitive organism (aquatic invertebrates) and by applying an assessment factor of 20 to account for acute-to-chronic extrapolation and species sensitivity variation, the predicted no-effect concentration (PNEC) was calculated to be in the range of 1000 to 10 000 µg/L, which was used to estimate the risk 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 activities is expected to be mainly from cleaning of transportation vessels by release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 10 to 100 µg/L. For potential activities such as manufacturing, environmental exposure is expected to be mainly from release of the substance to water resulting in a PEC in the range of 10 to 100 µg/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 harm to the environment in Canada.
Human health risk assessment
Based on the available hazard information, the substance has a moderate acute toxicity by the oral route (median lethal dose [LD50] 300 to 2000 mg/kg body weight) and a moderate acute toxicity by the dermal route (LD50 200 to 1000 mg/kg body weight). The substance has a moderate subchronic toxicity following repeated oral doses in mammalian test animals (no-observed-adverse-effect-level [NOAEL] 30 to 300 mg/kg-bw/day). The substance is expected to have a low reproductive/developmental toxicity following repeated oral doses in mammalian test animals (NOAEL > 300 mg/kg-bw/day with no adverse reproductive or developmental effects observed at the highest dose tested). The substance is expected to be corrosive; however, it is not expected to be a dermal sensitizer (0% response in a Buehler test). It is not mutagenic in vitro or clastogenic in vivo. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used in polyurethane foams, direct exposure of the general population is not expected due to the industrial nature of the use. Consumers may come into contact with end-use products containing the notified substance, however, the substance will be encapsulated within 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 low. No potential uses that could significantly increase human health risks compared to the notified uses were identified.
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 suspected 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