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Toxicity to terrestrial arthropods

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The assessment entity “tall oil” is a mixture of different saturated and unsaturated C16 -C18 fatty acids. Therefore, the endpoint is addressed with publicly available data on fatty acids with the same or similar structure, including conservatively fatty acids with a shorter chain (i.e. C14) if relevant and appropriate in accordance with previously applied read-across approaches (U.S. EPA Fact Sheet, 2008).

A registration dossier shall contain information on the environmental hazard assessment (Regulation 1907/2006, Article 10). For the environmental hazard assessment of tall oil, the standard testing regime set out in Annexes VII to IX is adapted in accordance with Section 1.2 and 1.3 of Annex XI so that “testing does not appear to be scientifically necessary” as follows:

(I) The ecotoxic potential of the fatty acid (tall oil) is assumed to be negligible. Fatty acids are generally not considered to represent a risk to the environment, which is reflected in their exemption from the obligation to register (Annex V, Section 9 and Regulation (EC) No 987/2008).

(II) Fatty acids are a natural component of soil and water, produced in the cells of plants and animals. Furthermore, fatty acids constitute a significant part of the normal daily diet of mammals, birds and fish (EFSA, 2013). Fatty acids as contained in plant and animal tissue can be expected to also represent a significant part of the normal daily diet of invertebrates. Fatty acids will be rapidly degraded in soil and water by the β-oxidation pathway (e.g. essential process in the citric acid cycle) and thus not expected to accumulate in the environment (EU RAR zinc distearate, 2008). Hence, an accumulation in the environment and long-term effects on plants and animals are not expected (Health Canada, 2017).

 (III) According to acute and short-term data of C7 to C18 fatty acids as reviewed by EFSA (2013), a the acute and chronic risk for birds and mammals is low (EFSA, 2013; Health Canada, 2017). Moreover, based on the results of laboratory studies, honey bees are relatively insensitive to potassium salts of natural fatty acids (EFSA, 2013, Health Canada, 2017). Extended laboratory tests with adult parasitic wasps (Aphidius rhopalosiphi), protonymphs of predatory mites (Typhlodromus pyri) and soil dwelling beatles (Poecilus cupreus) are available for agricultural products containing 22 % pelargonic acid (C9 fatty acid). The “extended laboratory data were used in a risk assessment and demonstrated a low risk to off-field non-target arthropods” (EFSA, 2013). Pelargonic acid with an expected higher water solubility and bioavailability (HERA, 2003) represents thus a worst-case for longer fatty acid chains (e.g. tall oil).

(IV) On the basis of acute and chronic aquatic data, fatty acids have a low potential for toxicity to invertebrates. Based on the absence of a hazard potential in the aquatic compartment, a similar low potential is assumed in soil.

In summary, based on laboratory studies with honeybees, soil and leave-dwelling arthropods exposed to agricultural products containing potassium salts of fatty acids, acute and chronic toxicity of fatty acids to terrestrial arthropods is low. Further, available aquatic data indicate a low toxic potential of fatty acids. Fatty acids as contained in plant and animal tissue are a natural component of soil, represent a significant part of the normal daily diet of soil invertebrates and are rapidly degraded and therefore not expected to accumulate. It is thus from a scientific point of view not required to perform additional tests on the toxicity of tall oil to soil arthropods since further test are not expected to provide more insight into the environmental toxicity and are not considered necessary for the environmental hazard assessment.

References:

U.S. Environmental Protection Agency, U.S. EPA (2008). Ammonium nonanoate (031802) Fact Sheet, OPP Chemical Code: 031802, p. 2

EFSA (2013). Conclusion on the peer review of the pesticide risk assessment of the active substance Fatty acids C7 to C18 (approved under Regulation (EC) No 1107/2009 as Fatty acids C7 to C20), European Food Safety Authority, Parma, Italy, Vol 11(1):3023

Health Canada’s PMRA, Pest Management Regulatory Agency (2017). Ammonium Salt of Fatty Acid Proposed Registration Decision PRD2017-04, p. 36

EU Risk Assessment Report, RAR - Zinc distearate (2008), CAS No. 557-05-1 & 91051-01-3. PART 1 Environment, p. 63

 

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