New substances: risk assessment summary, new substances notification 18790

Official title: New Substances Notification No. 18790: Benzoic acid, 4-[(4-chlorobenzoyl)amino]-, sodium salt (1:1) 

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 chemical, benzoic acid, 4-[(4-chlorobenzoyl)amino]-, sodium salt (1:1) (Chemical Abstracts Service Registry No. 1489170-67-3), can be classified as an aryl amide, benzoic acid salt.

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 manufacture of polyolefin films and molded articles. Potential activities may include manufacturing and formulation.

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 very high ready biodegradability (>85%). The substance is not expected to bioaccumulate based on its low to moderate octanol-water partition coefficient (log K_ow <5) and low estimated bioconcentration and bioaccumulation factors (<250 L/kg).

Ecological assessment

Based on the available hazard information, the substance has low acute toxicity in fish and aquatic invertebrates (no significant adverse effects observed in saturated solution), and moderate acute (median effective concentration 1-100 mg/L) and chronic (no-observed-effect concentration (NOEC) 0.1-10 mg/L) toxicity in algae. Using the NOEC from the most sensitive organism (algae) and by applying an appropriate assessment factor, the predicted no-effect concentration (PNEC) was calculated to be 10-100 µg/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 not expected. Release during transport is not expected, and the substance is expected to be encapsulated in the cured polymer matrix of plastic resins and significant leaching is not expected. Environmental exposure from potential activities is expected to be mainly from cleaning manufacturing equipment and losses during formulation activities by release of the substance to water. The predicted environmental concentration (PEC) for potential activities is estimated to be 1-10 µg/L for manufacturing activities and 0.01-0.1 µg/L for formulation activities.

Based on the low environmental release expected from notified activities, and comparing the PEC with the PNEC resulting in ratio of less than 1 for potential activities, the substance is unlikely to cause ecological harm in Canada.

Human health assessment

Based on the available hazard information, the 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 (90-day no-observed-effect level >100 mg/kg-bw/d). It is not a dermal sensitizer (estimated concentration to product a stimulation index of 3 >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 for the manufacture of polyolefin films and molded articles, consumers may come into contact with end-use products containing the substance, however direct exposure is not expected as the substance is expected to be encapsulated within the polymer matrix of cured plastic products. The concentration of the substance in end-use products is very low (0.05-0.2%) and leaching is expected to be very low (<<1%) due to its large particle size and low volatility, and based on the migration rate of similar plastic additives. Indirect exposure of the general population from environmental media such as drinking water is expected to be low. If polyolefin films are used in food-contact applications, indirect exposure of the general population due to leaching of the substance into foodstuffs is expected to be low as leaching is limited for the reasons mentioned above. No other potential uses have been identified.

Based on the low potential for direct or indirect exposure of the general population and its 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.

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.