New substances: risk assessment summary, new substances notification 20376
Official title: New Substances Notification 20376: Alkanes, C16-18-branched and linear
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 alkanes, C16-C18-branched and linear (Chemical Abstracts Service registry numberFootnote 1 2145099-01-8), 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 as a heat transfer fluid. Potential uses may include use in sealants, coatings, metal working fluids, personal care products, and fuels.
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 air, soil and sediment. The substance is not expected to be persistent in these compartments based on short atmospheric half-life (2-12 hours) and high biodegradability (>60% in 28 days). The substance is not expected to bioaccumulate based on bioconcentration factors for analogue substances (<1000 L/kg).
Environmental risk assessment
Based on the available hazard information, the substance is expected to have low acute and chronic toxicity to fish, aquatic invertebrates, and algae (no adverse effects observed in saturated solutions). A predicted no-effect concentration was not calculated given the low potential for ecological hazard.
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 to be mainly from cleaning of transportation vessels. Release of the substance to water resulting from these activities is expected to be negligible. A predicted environmental concentration was not calculated due to the low potential for environmental exposure and ecotoxicity. No potential activities which could significantly increase environmental risks compared to those notified were identified.
Based on the low potential for ecotoxicity, the substance is unlikely to cause ecological harm in Canada.
Human health risk assessment
Based on the available hazard information, the substance is expected to have a low acute toxicity by the oral and dermal route (median lethal dose >2000 mg/kg body weight) and low subchronic and reproductive/developmental toxicity following repeated oral doses in mammalian test animals (no-observed-adverse-effect level >1000 mg/kg-bw/day). It is expected to be a weak dermal sensitizer (>10% estimated concentration required to produce a stimulation index of 3 (local lymph node assay)). It is not mutagenic in vitro and is not expected to be clastogenic in vitro. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used as a heat transfer fluid, 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 and air is expected to be negligible given the low potential for environmental release and the high potential for degradation. Potential uses of the substance include personal care products, where direct exposure of the general population is expected to be mainly by contact with the skin at levels that that do not pose concern. Indirect exposure of the general population from environmental media such as drinking water and air is expected to be at levels that do not pose a concern, similar to that of the notified use.
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.
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.