New substances: risk assessment summary, new substances notification 18691

Official title: The chemical, methanol, potassium salt (Chemical Abstracts Service Registry No. 865-33-8), can be classified as a methanolate.

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 chemical, methanol, potassium salt (Chemical Abstracts Service Registry No. 865-33-8), can be classified as a methanolate.

Notified and potential activities

The substance is proposed to be imported into Canada in quantities greater than 10 000 kg/yr for use as a catalyst in the production of biodiesel. Potential uses may include synthesis of a variety of chemicals.

Environmental fate and behaviour

Based on its physical and chemical properties, if released to the aquatic environment or soil, the substance is expected to hydrolyze to methanol and potassium hydroxide in the presence of moisture. Based on the physical and chemical properties of the hydrolysis products, if released to the environment, the substance will tend to partition to water. The substance is not expected to be persistent in water based on its very high biodegradability (>85%). The substance is not expected to bioaccumulate based on its very low octanol-water partition coefficient (logK_ow ≤0) and estimated low bioconcentration and bioaccumulation factors (<250 L/kg).

Ecological assessment

Based on the available hazard information on structurally related chemicals, the substance is expected to have low acute toxicity in fish, aquatic invertebrates and algae (median lethal concentration and median effective concentration >100 mg/L). A predicted no-effect concentration was not calculated give the low potential for ecological risk.

The notified and 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 low. The substance will be used in industrial settings only with no commercial or consumer uses expected, and the substance will be consumed during use. The potential use of the substance as a chemical intermediate is expected to involve a similar industrial process as the notified activity. Therefore, environmental release from potential activities is expected to be low. A predicted environmental concentration for notified or potential activities was not estimated given the low potential for environmental release.

Based on the low ecotoxicity and low potential for environmental release, the substance is unlikely to cause ecological harm in Canada.

Human health assessment

Based on the available hazard information on structurally related chemicals, the substance has a moderate potential for acute toxicity by the oral route of exposure (median lethal dose (LD₅₀) 1000-2000 mg/kg body weight) and a low potential for acute toxicity by the dermal route of exposure (LD₅₀ >1000 mg/kg body weight with no lethality or significant toxicity findings). It is not mutagenic in vitro. Therefore, the substance is unlikely to cause genetic damage.

When the notified substance is used as a catalyst in the production of biodiesel, direct exposure of the general population is not expected due to the industrial nature of the use. Potential uses are similarly industrial in nature and include synthesis of a variety of chemicals. Indirect exposure of the general population from environmental media such as drinking water is not expected given the specialized industrial use of the substance, which results in little or no release to the environment.

Based on the low potential for direct or indirect 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 uses, it is not suspected to be harmful to human health or the environment according to the criteria under section 64 of CEPA.

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 workplace use.