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For the assessment of the terrestrial toxicity of MDIPA Esterquat C16-18 and C18 unsatd. an acute toxicity study in earthworms with the source substance MDEA-Esterquat C16-18 and C18 unsatd and a toxicity study in plants with the source substance MDEA-Esterquat C16-18 and C18 unsatd. are available. A justification for read-across is attached to Iuclid section 13.


 


Toxicity to soil macroorganisms


In a 14-day acute toxicity study, earthworms (Eisenia fetida) were exposed to MDEA-Esterquat C16-18 and C18 unsatd.  at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.


 


Toxicity to terrestrial plants


The effect of MDEA-Esterquat C16-18 and C18 unsatd. on seedling emergence and growth of the monocotyl oat (Avena sativa) and dicotyl lettuce (Lactuca sativa) crops was studied at nominal concentrations of 0 and 47.4 mg a.i./kg dry soil (1000 mg dispersion/kg dry soil). The study was conducted according to OECD TG 208. The growth medium used in the test was a mixture of natural soil and sand (1:1; pH 7.5; organic matter 1.1%). On day 17, the surviving plants per pot were recorded and cut at soil level for measuring the plant height and dry weight in the seedling emergence and vegetative vigour test, respectively. Seed germination was not affected by the MDEA-Esterquat C16-18 and C18 unsatd.  The 17 d NOEC based on seed germination was >47.4 mg a.i./kg dry soil. In the vegetative vigour test, the plant dry weight and plant height were not affected by MDEA-Esterquat C16-18 and C18 unsatd. treatment. The 17 d NOEC values based on plant growth (length and dry weight) was >47.4 mg a.i./kg dry soil.


 


Toxicity to soil microorganisms


According to REACH regulation (Annex IX, 9.4.2, column 2), toxicity testing with soil microorganisms does not need to be conducted. Testing can be substituted by the equilibrium partitioning method, based on aquatic tests. Testing shall be proposed if the results of the safety assessment indicate the need. Accumulation of the target substance in soil compartments (and thus, potential exposure of soil micro-organisms) is unlikely as the substance is readily biodegradable.


 


Toxicity to birds


No experimental data are available. According to REACH regulation (Annex XI, section 1), a long-term or reproductive toxicity study with birds does not need to be conducted as the biomagnification potential of the substance is expected to be low and secondary poisoning is unlikely.