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EC number: 275-118-0 | CAS number: 71010-76-9
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
Findings from a 28-day chronic soil nitrogen transformation test (OECD 216) showed that the registered substance did not cause any long-term effects on soil micro-organisms. The 28-day NOEC was ≥ 100 mg/kg soil d.w. based on no statistically significant effects on the 0-28 day nitrate formation rate in soil microflora. The registered substance is not expected to cause any long-term toxicity or adverse effects to soil micro-organisms. No PNEC for soil could be derived for quantitative risk assessment. However, it is possible to qualitatively conclude that the registered substance does not pose an unacceptable risk to soil organisms.
Key value for chemical safety assessment
Additional information
Discussion:
In this 2014 GLP study conducted according to OECD 216 guidelines,the registered substance was evaluated at soil concentrationsof 0, 1, 10 and 100mg/kg dry wt (d.w.) to determine the effecton the transformation of an organic nitrogen source (lucerne) to nitrate over a period of 28 days in soil microorganisms (Carter, 2014). No statistically significant difference in the 0-28 daynitrate formation rate was seen at the 1, 10 or 100 mg/kg soil (d.w.) concentration group compared to that in the control soilgroup, indicating that the 28-day no-observed effect concentration (NOEC) was >100 mg/kg soil (d.w.). The 28-day EC50 value was >100 mg/kg soil (d.w.). There was no dose-response observed over the exposure levels investigated. In summary, the registered substance showed no long-term effect to soil microorganisms under the conditions of the OECD 216 test, even at the highest soil nominal concentration of 100 mg/kg (d.w.). These findings indicate that the registered substance is not expected to cause any long-term effects to soil micro-organisms.
The following information is taken into account for toxicity on soil micro-organism for the derivation of PNEC
Based on the above study results, it can be concluded that the registered substance is not expected to cause long-term adverse effects to soil microflora. The 28-day NOEC >100 mg/kg d.w. and the 28-day EC50 > 100 mg/kg dw were based on nitrogen transformation rate effects in soil microorganisms.
Besides not causing long-term adverse effects to soil microorganisms, the registered substance did not have long-term effect on terrestrial earthworm reproduction and growth in a 56-day OECD 222 test (Kelley 2014) and did not have any acute mortality to earthworms in a 14-day OECD 207 acute toxicity test (Kelley 2013). Furthermore, the registered substance did not have any long-term effects on the seedling emergence, growth and reproduction of two terrestrial plants,B. rapaandA. sativain 35-day and 52-day ISO 22030 chronic plant toxicity tests, respectively (Butler, 2014). Lastly, findings from a 28-day chronic sediment toxicity study (OECD 225) indicate that the registered substance did not cause any long term effect on mortality, growth (biomass) or reproduction (i.e., number of live worms) in the benthicLumbriculus variegatusa in sediment (Sutherland, 2014). .Collectively, these findings as well as the previously discussed lack of acute and chronic aquatic toxicity provide further support that the registered substance, CAS 71010-76-9), is not likely to pose a concern to soil micro-organisms. The lack of adverse effect on soil organism is probably attributable to the low water solubility, high log Kow (inability to cross biomembrane) and low bioavailability of the registered substance. In addition, the registered substance is readily biodegradable, rapidly metabolized and it is not persistent or bioaccumulative. Exposure to the registered substance in the terrestrial or soil compartment is likely to be negligible.
As no PNEC for water could be determined (no aquatic toxicity), it is not possible to derive a PNEC for soil using the EqPM (equilibrium partitioning method). The available toxicity data indicate that the registered substance is not expected to cause any adverse effects to soil micro-organisms. While it is not possible to derive PNECs needed for quantitative risk assessment, it is possible to qualitatively conclude based on the available short- and long-term terrestrial test data that the registered substance does not pose an unacceptable risk to soil micro-organisms.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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