New substances: risk assessment summary, new substances notification 20905
Official title: New Substances Notification 20905: Ethanone, 1-(4-hydroxyphenyl)- (Chemical Abstracts Service Registry Number 99-93-4)
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 ethanone, 1-(4-hydroxyphenyl)- (Chemical Abstracts Service Registry NumberFootnote 1 99-93-4).
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 cosmetics, natural health products, and drug products. Potential uses may include use as a food-flavouring agent.
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. As a surfactant, some of the substance will also be present at the surface of the water. The substance is not expected to be persistent in these compartments based on its susceptibility to biodegradation (> 85% over 28 days). The substance is not expected to bioaccumulate based on its high water solubility, low octanol-water partition coefficient (log Kow 0-3), and low estimated bioconcentration factor (< 250 L/kg).
Environmental risk assessment
Based on the available hazard information, the substance is expected to have moderate acute toxicity to fish, aquatic invertebrates and algae (median lethal concentration and median effective concentration 1-100 mg/L) and moderate chronic toxicity to aquatic invertebrates (10% effective concentration (EC10) 0.1-10 mg/L). Using the EC10 from the most sensitive organism (aquatic invertebrates) and by applying an assessment factor of 2 to account for species sensitivity variation, the predicted no-effect concentration (PNEC) was calculated to be in the range of 100-1000 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 are expected to be mainly from industrial processing of personal care products and consumer use and from release of the substance to water resulting in a predicted environmental concentration (PEC) in the range of 0.1-1 µg/L. For potential activities such as manufacturing and industrial processing as a food additive, environmental exposure is expected to be mainly from release of the substance to water resulting in environmental exposure expected to be quantitatively similar to that of the notified use.
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 low acute toxicity by the oral and dermal routes (median lethal dose > 2000 mg/kg body weight) and low subchronic and reproductive/developmental toxicity following repeated oral doses in mammalian test animals (28-day no-observed-adverse-effect level > 300 mg/kg bw/day). It is not a dermal sensitizer (0% response (guinea pig maximization 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 cosmetics, natural health products, and drug products, direct exposure of the general population is expected to be mainly by contact with the skin. Indirect exposure of the general population from environmental media such as drinking water is expected to be at low levels given the low potential for environmental release. Potential uses of the substance include as a food-flavouring agent, where direct and indirect exposure of the general population is expected to be at levels that do not pose a concern, similar to that of the notified use.
Based on the 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.