New substances: risk assessment summary, new substances notification 18620

Official Title: New Substances Notification No. 18620: Ethanediamide, bis[3-(diisopolyalkylamino)propyl]-

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, ethanediamide, bis[3-(diisopolyalkylamino)propyl]- (Confidential Accession No. 19016-8), can be classified as an aliphatic amino-amide.

Notified and potential activities

The substance is proposed to be manufactured in and/or imported into Canada in quantities greater than 10 000 kg/yr for use as a lubricant additive. No other activities are anticipated in Canada.

Environmental fate and behaviour

Based on its physical and chemical properties, if released to the environment, the substance will tend to partition to soil and sediment. The substance is expected to be persistent in soil and sediment based its low biodegradability (10-30%). The substance is not expected to bioaccumulate based on its high molecular weight which will limit its ability to cross biological membranes.

Ecological assessment

Based on the available hazard information, the substance has moderate acute toxicity in fish and aquatic invertebrates (median lethal loading (LL50) and median effective loading >100 mg/L), and low to moderate acute toxicity in algae (LL50 >1 mg/L). Given the very low solubility and high molecular weight of the substance, it is not expected to be bioavailable to aquatic organisms and therefore is considered to have low toxicity in aquatic organisms. A predicted no-effect concentration was not calculated given the low potential for ecological risk.

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 activity is expected to be mainly from the cleaning of transportation containers and formulation vessels resulting in the release of the substance to the aquatic environment via wastewater. The predicted environmental concentration (PEC) for notified activities is estimated to be 0.1-10 µg/L. Environmental exposure due to potential manufacturing activities is expected to be similar.

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 ecological harm in Canada.

Human health assessment

Based on the available hazard information, the notified substance has a low potential for acute toxicity by the oral and dermal routes of exposure (median lethal dose >2000 mg/kg body weight) and a low potential for subchronic toxicity following repeat oral doses in mammalian test animals (28-day no-observed-adverse-effect level >300 mg/kg-bw/d). It is a moderate sensitizer (effective concentration 1-10% (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/commercial lubricants, direct exposure of the general population is not expected. The substance may be used in do-it-yourself lubricant applications which could lead to direct contact of the general population with the substance mainly by dermal contact, however the potential for direct exposure is expected to be low. Dermal exposure to the lubricant is expected to be infrequent and transient in nature, and due to its high molecular weight and very high octanol-water partition coefficient (log Kow >8), the substance is not expected to effectively cross the skin barrier and therefore dermal uptake and systemic distribution will be mitigated. Indirect exposure of the general population from environmental media such as drinking water is expected to be low. Owing to the specialized use and conditions of transport, processing, use and disposal under this notification, significant environmental releases are not expected. No other potential uses were identified.

Based on the low potential for significant exposure and low acute and subchronic 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.

Assessment conclusion

When the substance is used as notified, 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.

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