Chemical name: 2-Propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Banned

Use or uses prohibited by the final regulatory action:

The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items.

Use or uses that remain allowed:

N/A

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

The Prohibition of Certain Toxic Substances Regulations, 2012 prohibit the manufacture, use, sale, offer for sale and import of toxic substances listed in Schedules 1 and 2. This substance is found in Part 2 of Schedule 1, which lists prohibited toxic substances subject to total prohibition, unless present in manufactured items.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Based on the available information on the physical and chemical properties of the fluorotelomer-based polymers, direct and indirect exposure of the general population to the fluorotelomer-based polymers and their hazardous degradation products is expected to be low at the intended annual import quantities.

Based on available data, as well as surrogate data, the fluorotelomer-based polymers are expected to show low acute oral toxicity, low skin and eye irritation potential, and low reproductive and developmental toxicity; however they are likely to display moderate subchronic oral toxicity, with possible effects on the thyroid, liver, and kidney.

The toxicological profile of the anticipated ultimate degradation products of the fluorotelomer-based polymers (i.e. PFCAs) is not expected to differ significantly from that of PFOA and its salts .Based on available data, perfluorooctanoic acid (PFOA) and its salts are not genotoxic but are tumourigenic and immunotoxic in rodents, and display moderate reproductive and developmental toxicity in rodents and moderate to high subchronic oral toxicity in rodents and monkeys. As a result, there is reason to suspect that the degradation products of the fluorotelomer-based polymers, and in particular the PFCAs, may have the potential to cause adverse health effects in humans.

Direct Exposure to Humans:

Surface protection of consumer products

Dermal contact with the fluorotelomer-based polymers is likely as the substances are intended to be applied to carpeting and fabrics. Long-term dermal exposures are possible since leaching from and rub-off of the fluorotelomer-based polymer from various substrates will occur during the lifetime of garments and carpeting. However, dermal uptake of the fluorotelomer-based polymers is unlikely due to the expected low proportion of components smaller than 1000 daltons.

Spray-on applications

Moderate to high direct exposure of the general population may occur during spray-on application of fabric protection products available to the consumer. The substances could be formulated for aerosol use, thereby facilitating spray application of the product to leather garments or upholstery. Although the volatility of the fluorotelomer-based polymers themselves is expected to be negligible due to the low proportion of molecular weight species smaller than 1000 daltons, there is the potential for inhalation and dermal exposure during the consumer application of an aerosol formulation.

The overall inhalation exposure to the fluorotelomer-based polymers will depend on the frequency of use of these products. Thus, the potential for direct exposure of the general population to the substances is expected to be moderate to high through inhalation. Uptake of the fluorotelomer-based polymers following inhalation exposure is not expected due to the negligible proportion of low molecular weight components; however, deposition of the fluorotelomer-based polymers in the lungs is possible and would depend on the particle size distribution of the aerosol, which is unknown for the formulations.

Commercial coatings and inks

Once the paints, coatings or inks have dried, the substance will be incorporated into a solid matrix from which it is unlikely to be readily released. Therefore, the potential for direct exposure to the fluorotelomer-based polymers in these commercial uses is expected to be negligible.

Expected effect of the final regulatory action in relation to human health:

The Regulations prevent the introduction of new sources of PFCAs into Canada, thereby protecting the environment and human health. The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items.

Summary of known hazards and risks to the environment:

The assessment has concluded that fluorotelomer alcohols (FTOHs) are released from the fluorotelomer-based polymer as unreacted residuals or as degradation products, and ultimately degrade to the highly persistent perfluorinated carboxylic acids (PFCAs). All of the PFCAs formed are expected to remain in the environment as there are no known environmental degradation mechanisms.

Although the experimental evidence is not available demonstrating the occurrence, mechanism or rate of degradation from the fluorotelomer-based polymer, the release of the FTOH can be expected to occur based on the chemistry of the substance and substantial empirical evidence demonstrating susceptibility of this chemistry to hydrolysis. The rate of release may be faster or slower than rates observed in surrogate chemicals due to such factors as steric hindrance, however the rate is not considered of significant environmental importance given the exceptional stability of the ultimate degradation product, PFCAs.

Atmospheric long range transport of FTOH can be used to explain the presence of the longer chain PFCAs in biota in remote regions of Canada. It is noted that atmospheric monitoring is limited to shorter chains of fluorotelomer alcohol rather than the longer chain lengths and therefore the measured levels of FTOH may not adequately explain the presence of the long chain PFCAs found in remote regions. Nonetheless, the evidence to support this transport mechanism is provided through experimental evidence demonstrating the volatile nature of FTOH, measurements of related FTOH in the atmosphere, and atmospheric chamber reaction studies demonstrating possible mechanisms. The measurements of longer chain PFCAs in remote regions of Canada give support to this transport mechanism and provide a scientifically defensible explanation of their presence. It is important to emphasize that the presence of PFCAs in remote regions should not be attributed to a single fluorinated substance, single source or single mechanism of transport and local sources of contaminants and emissions from other jurisdictions may also contribute.

Although acute toxicity to aquatic organisms following exposure to the degradation products appears to be low, evidence for chronic effects remains unknown. Toxicity studies to laboratory mammals indicate the potential to cause adverse health effects in wildlife.

In summary, the fluorotelomer-based polymer is expected to degrade, release FTOH, undergo long range atmospheric transport and/or degrade further to PFCAs. Available evidence indicates that the longer chain PFCAs (=C9) are susceptible to bioaccumulation and biomagnification, have been found in remote regions, and notably exhibit characteristics of persistent organic pollutants (POPs). These unique characteristics combined with the potential for long term adverse effects, warrant concern for the environment.

Expected effect of the final regulatory action in relation to the environment:

The Regulations prevent the introduction of new sources of PFCAs into Canada, thereby protecting the environment and human health. The prohibition prevents industry from importing, manufacturing, using, selling and offering for sale these substances, unless they are present in manufactured items.

Date of entry into force of the final regulatory action: 13/10/2010