New substances: risk assessment summary, new substances notification 18344

Official title: New Substances Notification No. 18344: D-glucopyranose, oligomeric, heptyl glycosides

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 that 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

D-glucopyranose, oligomeric, heptyl glycosides (Chemical Abstracts Service Registry No. 1627851-18-6) is a chemical that can be classified as an alkyl polyglycoside.

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 in cosmetic applications and cleaning formulations. Other potential uses may include decorative paints.

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 high biodegradation potential. The substance is not expected to bioaccumulate based on its low predicted bioconcentration and bioaccumulation factors (<250 L/kg).

Ecological assessment

Based on the available hazard information on the substance and surrogate data on structurally related chemicals, the substance has low acute toxicity in fish, aquatic invertebrates and algae (median effective concentration >100 mg/L). The predicted no-effect concentration was not calculated given the low potential for 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 and other potential activities is expected to be mainly from processing, cleaning and consumer use by release of the substance to water. Environmental exposure levels are expected to be low as consumer use will be widely dispersed across Canada and concentrations of the substance in end use products is low. The predicted environmental concentration was not calculated given the the low hazard profile of the notified substance and its ability to readily biodegrade.

Based on the low potential for ecotoxicity, 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 route 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-adverse-effect level >100 mg/kg bw/d). It is not a skin sensitizer and is not mutagenic in vitro. Therefore, the substance is unlikely to cause genetic damage.

When used in cosmetic applications and cleaning formulations, direct exposure of the general population is expected to be mainly by contact with the skin. For its potential use in decorative paints, 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.

Based on the low potential for 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.