New substances: risk assessment summary, new substances notification 19015

Official title: New Substances Notification No. 19015: Alkylalcohol reaction products with phosphorus oxide, compounds with alkylalkaneamine

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 alkylalcohol reaction products with phosphorus oxide, compounds with alkylalkaneamine (Confidential Accession No. 19170-8), and is a substance referred to as unknown or variable composition, complex reaction products or biological materials (UVCB).  

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 the notified use as an industrial oil additive. Potential uses are expected to be similar to those notified.

Environmental fate and behaviour

Based on its physical and chemical properties, 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 moderate biodegradation (30-60%). The substance is not expected to bioaccumulate based on its low to moderate octanol-water partition coefficient (log Kow <5) and low predicted bioaccumulation and bioconcentration factors (<250 L/kg).  

Ecological assessment

Based on the available hazard information on the substance and surrogate data on structurally related chemicals, the substance is expected to have low to moderate acute toxicity in fish (median lethal concentration >1 mg/L) and moderate acute toxicity in aquatic invertebrates (median effective concentration and median effective loading rate 1-100 mg/L). The substance is expected to have moderate chronic toxicity in aquatic invertebrates and algae (no-observed-effect-level (NOEL) 0.1-10 mg/L). Using the NOEL from the most sensitive organism (aquatic invertebrates) and by applying an appropriate assessment factor, the predicted no-effect concentration (PNEC) was calculated to be 0.1 to 1 mg/L, which was used to estimate the ecological risk.  

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 cleaning of transportation vessels and formulation by release of the substance to water at rates of 10 to 100 kg/day for transportation vessel cleaning and 0.1 to 1 kg/day for formulation. The predicted environmental concentration (PEC) is estimated to be 0.01 to 0.1 mg/L for cleaning of transport vessels and 0.001 to 0.01 mg/L for formulation. For potential activities such as manufacturing and consumer use, environmental exposure is expected to be similar to that of the notified use (cleaning of transportation vessels).   

Comparing the PEC for notified and potential activities 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 on the substance and surrogate data on structurally related chemicals, the substance has a low potential for acute toxicity by the oral and dermal routes of exposure (median lethal dose >2000 mg/kg bw) and low subchronic toxicity following repeat oral doses in mammalian test animals (28-day no-observed-adverse-effect level (NOAEL) >300 mg/kg-bw/day). The substance is expected to have low reproductive/developmental toxicity (NOAEL >250 mg/kg-bw/day with no significant, human-relevant effects observed). It is a moderate skin sensitizer (1-10% estimated concentration required to produce a stimulation index of 3 (EC3) (local lymph node assay)). It is not mutagenic or clastogenic in vitro and is not expected to be clastogenic in vivo. Therefore, the substance is unlikely to cause genetic damage.  

The provisional tolerable daily intake (PTDI) was calculated to be 1 to 10 mg/kg-bw/day based on the NOAEL of the oral subchronic toxicity study in mammalian test animals. The no-expected-sensitization-induction level (NESIL) was calculated to be 0.1 to 1 mg/cm2 based on the EC3 from the local lymph node assay.

When the notified substance is used as an industrial oil additive, 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 is expected to be at levels of 0.0001 to 0.001 mg/kg-bw/day. If the substance is used as an oil additive for consumer applications, direct exposure of the general population is expected to be mainly by contact with the skin at levels of 0.01 to 0.1 mg/cm2 for dermal exposure and 0.01 to 0.1 mg/kg for systemic exposure. Indirect exposure of the general population from environmental media such as drinking water is expected to be similar to that of the notified use.

Based on a comparison of the PTDI and NESIL to the estimated 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 used as notified or for other identified potential uses, the substance 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 Hazardous Products Regulations for products intended for the workplace.

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