New substances: risk assessment summary, new substances notification 20983
Official title: New Substances Notification 20983: Amides, from 2-(2-aminoethoxy)ethanol manuf. low-boiling by-products and low-boiling tall-oil fatty acids (Chemical Abstracts Service Registry Number 70131-54-3)
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 amides, from 2-(2-aminoethoxy)ethanol manuf. low-boiling by-products and low-boiling tall-oil fatty acids (Chemical Abstracts Service Registry NumberFootnote 1 70131-54-3), and is considered a substance of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB).
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 metalworking fluids. Potential uses may include use in various commercial or consumer products.
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, soil and sediment. As a surfactant, some of the substance will also be present at the surface of the water or adsorb to suspended organic matter. The substance is not expected to be persistent in these compartments based on its ready biodegradation (60-85% over 28 days). The substance is not expected to bioaccumulate based on its moderate expected bioconcentration factor (250-1000 L/kg).
Environmental risk assessment
Based on the available hazard information, the substance has moderate acute toxicity to aquatic invertebrates (median effective loading rate (EL50) 1-100 mg/L; median effective concentration 1-100 mg/L), low to moderate acute toxicity to fish (median lethal loading rate >1 mg/L, with no mortality at the highest loading rate tested; median lethal concentration > 1 mg/L, with no mortality at the highest concentration tested), and moderate chronic toxicity to algae (no-observed-effect loading rate 0.1-10 mg/L; 10% effective concentration 0.1-10 mg/L). Using the EL50 from the most sensitive organism (aquatic invertebrates) and by applying an assessment factor of 50 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 10-100 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 activity is expected to be mainly from cleaning of transportation vessels from release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 1-10 µg/L, and from industrial use from 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 release of the substance to water resulting in a PEC in the range of 1-10 µg/L. For potential activities such as use in various commercial or consumer products, environmental exposure is expected to be mainly by release of the substance to water at low rates.
Comparing the PECs with the PNEC, the ratios are 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 and dermal routes (median lethal dose > 2000 mg/kg body weight) and low subchronic toxicity following repeated oral doses in mammalian test animals (28-day no-observed-adverse-effect level (NOAEL) > 300 mg/kg-bw/day). The substance has a low reproductive/developmental toxicity following repeated oral doses in mammalian test animals (NOAEL > 300 mg/kg-bw/day). It is not a dermal sensitizer (estimated concentration of > 10% required to produce a stimulation index value of 3 in a local lymph node assay). It is not mutagenic or clastogenic in vitro. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used in industrial applications, 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 such as drinking water is conservatively estimated to be at levels in the range of 10-4 to 10-3 mg/kg body weight for infants and 10-5 to 10-4 mg/kg body weight for adults. Potential uses of the substance include consumer uses such as personal care products where direct exposure of the general population is expected to be mainly by contact with the skin at levels of 0.001 to 0.01 mg/kg bw/day for teenagers and adults based on exposure levels calculated for similar fatty alkanolamide substances. Indirect exposure of the general population from environmental media such as drinking water is estimated to potentially be at levels in the range of 10-4 to 10-3 mg/kg bw/day for infants and 10-6 to 10-5 mg/kg bw/day for adults.
The target margin of exposure (MOET) was calculated to be 100 based on the available information. The MOET is the level of exposure at or above which there is no expected risk in the exposed population. The derived margin of exposure (MOED) is the ratio of the point of departure value to the available exposure doses and is compared to the MOET. As the MOED is higher than the MOET for all estimated human exposures, 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 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.