New substances: risk assessment summary, new substances notification 19352
Official title: New Substances Notification No. 19352: 1,2,-Ethanediamine, N1-(2-aminoethyl)-, reaction products with maleated alkylenealkane (Confidential Accession No. 19236-4)
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-(2-aminoethyl)-, reaction products with maleated alkylenealkane (Confidential Accession No. 19236-4), and is considered a substance of unknown or variable composition, complex reaction products or biological materials (UVCB).
Notified and potential activities
The substance is proposed to be imported into Canada in quantities greater than 10 000 kg/yr for the notified use as an oil additive. No other potential uses are anticipated to be likely 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 based on its very low biodegradability (≤10% over 28 days). The substance is not expected to bioaccumulate based on its high molecular weight which will limit its ability to cross biological membranes.
Ecological assessment
Based on the available hazard information on the substance and surrogate data on structurally related chemicals, the substance is expected to have low acute toxicity in fish and aquatic invertebrates (median lethal loading rate and median effective loading rate (EL50) >100 mg/L) and low chronic toxicity in aquatic invertebrates and algae (10% lethal loading rate and no-observed-effect-level >10 mg/L). A predicted no-effect concentration was not calculated given the low potential for ecological hazard.
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 processing and cleaning of transportation vessels , with release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 1-10 µg/L, and from its use as an oil additive, with release of the substance to water resulting in a PEC in the range of 0.1-1 µg/L. For potential activities such as manufacturing, environmental exposure is expected to be mainly from the release of the substance to water resulting in a PEC in the range of 1-10 µg/L.
Based on the low potential for ecotoxicity, the substance is unlikely to cause ecological harm in Canada.
Human health assessment
Based on the available hazard information, the substance has a low acute toxicity by the oral and dermal routes (median lethal dose >2000 mg/kg body weight) and low subchronic toxicity following repeat oral doses in mammalian test animals (28-day no-observed-adverse-effect level (NOAEL) >300 mg/kg bw/day). The substance has low reproductive/developmental toxicity following repeat oral doses in mammalian test animals (NOAEL >1000 mg/kg bw/day). It is not a skin sensitizer (0% response (Buehler scale)). It is not mutagenic in vitro or clastogenic in vitro or in vivo. Therefore, the substance is unlikely to cause genetic damage. The provisional tolerable daily intake (PTDI) was calculated to be in the range of 1000-10 000 µg/kg bw/day based on the NOAEL of the oral subchronic toxicity study in mammalian test animals. The PTDI is the estimated long-term exposure without risk of adverse health effects,
When the notified substance is used as an oil additive industrially or commercially, direct exposure of the general population is not expected since the substance will be contained within a closed system. When products containing the notified substance are used by consumers, direct exposure of the general population is expected to be mainly by contact with the skin at low levels. Systemic exposure will be limited by infrequent use, the low concentration of the notified substance in end-use products and its high molecular weight and octanol-water partition coefficient (log Kow >8) which will limit its ability to cross biological membranes. Indirect exposure of the general population from environmental media such as drinking water is conservatively estimated to be at levels in the range of 0.1-1 µg/kg bw/day for children and adults.
If potential activities for the substance were to include manufacturing, direct exposure of the general population would be expected to be similar to that of the notified use. Indirect exposure of the general population from environmental media such as drinking water is conservatively estimated to be at levels in the range of 0.01-0.1 µg/kg bw/day for children and adults.
Because all estimated human exposures are less than the PTDI, meaning at levels that do not pose a concern, 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 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 Hazardous Products Regulations for products intended for the workplace.