Registration Dossier
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EC number: 605-140-1 | CAS number: 158237-07-1
Sediment toxicity
Administrative data
Link to relevant study record(s)
- Endpoint:
- sediment toxicity: long-term
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.14 (ECHA, 2017) substances with a high potential to adsorb onto sediment (e.g. log Kow > 5 or Log Koc > 3) require sediment assessment even at tonnages below 1000 t/y. Therefore, at least a screening assessment using the equilibrium partitioning method (EPM) has to be performed for such substances. The substance has a log Koc of 1189 to 2380 L/kg (batch equilibrium method, OECD 106) at 20°C. Thus, a sediment assessment is mandatory and the equilibrium partitioning method (EPM) was applied to derive the PNEC sediment. In this case, the PEC/PNEC ratio (RCR) can be derived for the assessment of the sediment toxicity. If the PEC/PNEC ratio is < 1, no risk for the sediment compartment is indicated for the substance under consideration and further tests are not needed. The environmental exposure assessment for the test substance according to Annex XI, Section 3 of Regulation (EC) No 1907/2006 indicates no risk for the aquatic compartment (all RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). Thus, as the RCR is < 1, no risk for the sediment compartment is indicated and further tests are not needed.
Furthermore, the EPM is based on the aquatic toxicity data which show algae (ErC50 (72 h) = 6.04 µg/L, NOErC (72 h) = 0.49 µg/L, initial measured) as being by far the most sensitive organisms. The difference between sensitivity demonstrated in aquatic invertebrates (EC50 (48 h) = 100 µg/L, nominal) and algae is around factor 16. Therefore, it is expected that the calculated PNEC sediment with EPM is much lower than expected compared to a calculated PNEC sediment from an experimental study with sediment organisms. Since aquatic invertebrates are by far not considered to be the most sensitive species based on studies with organisms from the surface water, invertebrate species from the sediment are not expected to be more sensitive either. In addition, the substance is a herbicide which implicated plants to be the most sensitive organism group with the highest expected toxicity. Thus, the PNECaqua freshwater used to calculate the PNEC sediment (freshwater) by EPM is based on the most sensitive organism group.
Furthermore, based on a study investigating the potential for bioaccumulation, the substance is not bioaccumulative. The substance accumulated in bluegill sunfish with a total residue kinetic bioconcentration factor of about 275.5 to 289.8 X for whole fish (sum of radio labelled compounds, parent substances, metabolites and mineralization products). The steady-state-BCF (based on whole fish, wet weight) was determined to be 71 and the steady-state-BCF (normalised to 6% lipid content) is about 54. Thus, bioaccumulation could be excluded and the substance is expected to have a low accumulation potential.
Conclusion
The substance has a high potential to adsorb onto sediment due to a log Koc > 3. Due to a RCR below one no risk for the sediment compartment is indicated and no further tests are needed. Additionally, the difference between sensitivity demonstrated in aquatic invertebrates and algae is around factor 16. Therefore, it is expected that the calculated PNEC sediment with equilibrium partitioning method (EPM) is much lower than expected for a calculated PNEC sediment with effect values from an experimental sediment toxicity test. In addition, the substance is a herbicide which implicated plants and not invertebrates species to be the most sensitive organism group with the highest expected toxicity. Furthermore, based on a study investigating the potential for bioaccumulation, the substance is not bioaccumulative. Overall, no sediment toxicity test is needed.
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