New substances: risk assessment summary, new substances notification 18631
Official Title: New Substances Notification No. 18631: Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[4-(1,1-dimethyethyl)phenyl]-2,5-dihydro-
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, pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[4-(1,1-dimethyethyl)phenyl]-2,5-dihydro- (Chemical Abstracts Service Registry No. 84632-59-7), can be classified as a diketo-pyrrolopyrrole.
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 industrial, commercial and consumer coatings. Potential uses may include a variety of other applications, such as inks and toners, fillers, lubricants and other additives, adhesives and binding agents, cleaning/washing agents, and fuel additives.
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 on its very low biodegradability (≤10%). The substance is not expected to bioaccumulate based on its experimentally determined biomagnification factor (<1) which is indicative of low bioaccumulation potential.
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 and low chronic toxicity in aquatic invertebrates (no adverse effects observed in saturated solution). A predicted no-effect concentration was not calculated given the expected 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 activities is expected to result from the cleaning of transportation and formulation vessels by release at low levels to the aquatic environment via wastewater. A predicted environmental concentration for notified and other potential activities (e.g., manufacturing) was not estimated given the expected low potential for environmental exposure and ecological risk.
Based on the low potential for significant environmental exposure and low ecotoxicity, the substance is unlikely to cause ecological harm in Canada.
Human health assessment
Based on the available hazard information on the notified 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 body weight) and a low potential for subchronic toxicity following repeat oral doses in mammalian test animals (28-day no-observed-adverse-effect level (NOAEL) >300 mg/kg-bw/d). The substance has a low potential for reproductive and developmental toxicity (NOAEL >1000 mg/kg-bw/d). It is not a skin sensitizer. 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 or commercial coatings, consumers may come into contact with end-use products containing the substance, however direct exposure is not expected because the substance will be chemically reacted into a stable matrix once cured and will be unavailable for uptake. Dermal contact may occur upon application of consumer paints; however, exposure is expected to be limited by the incidental amount of paint in contact with the skin and infrequent use. Inhalation of the substance from aerosol products is expected to be low when used as directed with proper ventilation. The notified substance may be used in a variety of other applications, such as inks and toners, fillers, lubricants and other additives, adhesives and binding agents, cleaning/washing agents, and fuel additives. Direct exposure from potential uses is expected to be similar to or lower than that of the notified use. Indirect exposure of the general population from environmental media such as drinking water is expected to be low as significant environmental release of the substance is not expected.
Based on the 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, 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.