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Ecotoxicological information

Toxicity to soil macroorganisms except 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) 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 sum, 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 organisms 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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