New substances: risk assessment summary, new substances notification 21051
Official title: New Substances Notification 21051: Waxes and waxy substances, rice bran, oxidized, calcium salts (Chemical Abstracts Service Registry Number 1850357-57-1)
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 waxes and waxy substances, rice bran, oxidized, calcium salts (Chemical Abstracts Service Registry NumberFootnote 1 1850357-57-1), 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 industrial, commercial and consumer applications as a component in polishes, coatings, inks and plastics, and in plastic manufacturing. Potential uses may include personal care products, household cleaning products, food packaging materials and other 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 soil and sediment. The substance is not expected to be persistent in these compartments based on the expected inherent biodegradation (10% to 30% over 28 days) from an analogue substance. The substance is not expected to bioaccumulate based on its limited bioavailability and inherent biodegradation.
Environmental risk assessment
Based on the available hazard information, the substance has low acute toxicity to fish (median lethal loading rate > 100 mg/L) and is expected to have low acute toxicity to aquatic invertebrates (median effective loading rate > 100 mg/L) and low chronic toxicity to algae (10% effective loading rate > 10 mg/L). A predicted no-effect concentration was not calculated given the low potential for hazard 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 use in industrial, commercial or consumer applications from release of the substance to water at low rates. For potential activities such as manufacturing or use in various other applications, environmental exposure is expected to be at levels that do not pose a concern, similar to that of the notified use. A predicted environmental concentration was not calculated due to the low potential for environmental exposure and ecotoxicity.
Based on the low potential for ecotoxicity and environmental exposure, the substance is unlikely to cause harm to the environment in Canada.
Human health risk assessment
Based on the available hazard information, the substance is expected to have low acute toxicity by the oral route (median lethal dose > 2000 mg/kg body weight) and has low subchronic toxicity following repeated oral doses in mammalian test animals (90-day no-observed-adverse-effect level > 100 mg/kg-bw/day). It is not expected to be a dermal sensitizer (estimated concentration required to produce a stimulation index of 3 is > 10% in the local lymph node assay). It is not mutagenic or clastogenic in vitro and is not genotoxic in vivo. Therefore, the substance is unlikely to cause genetic damage.
When the notified substance is used as a component in coatings, plastics, and as a plastic mold release agent consumers may come into contact with end-use products containing the substance, however, direct exposure is not expected because the substance will be cured within a stable matrix and will be unavailable for uptake. When the notified substance is used as a component in various types of polish, including for shoes, cars and floors, direct exposure of the general population is expected to be mainly by contact with the skin, however, use of these products is anticipated to be sporadic and contact will be incidental. Systemic exposure will be limited by the high molecular weight and high octanol-water partition coefficient (log Kow > 8) of most components of the notified substance. These characteristics of the notified substance would likely inhibit systemic bioavailability. Indirect exposure of the general population from environmental media such as drinking water and air is not expected given the low potential for environmental release. Potential uses of the substance include personal care products, cosmetics, household cleaning products and food packaging materials, where direct exposure of the general population to the substance may be high. The hazard of the substance is very low, however, and is expected to be at levels that do not pose a concern, similar to that for the notified use.
Based on low toxicity 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.