Registration Dossier
Registration Dossier
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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
The 21-d NOEC on reproduction was determined at 0.63 mg/L.
The 21 -d EC10 was 0.63 mg/L (95% CL: 0.5786 – 0.69 mg/L; nominal, recalculated, BASF SE, 2019). The 21 -d EC20 was determined to be 0.69 mg/L (95% CL: 0.63 – 0.76 mg/L; nominal, recalculated, BASF SE, 2019).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.63 mg/L
Additional information
A guideline chronic study for aquatic invertebrates is available for epoxiconazole. The key study is a flow-through test with Daphnia magna, conducted according to EEC Guideline XI/681/86. Nominal test concentrations were 0, 0.039, 0.078, 0.156, 0.313, 0.625, 1.25, 2.5, 5 and 10 mg/L. The 21-d NOEC on reproduction was determined at 0.63 mg/L (analytically verified, BASF AG, 1992).
The data of the original report were re-evaluated using ToxRat v3.2.1 in order to obtain an EC10, which is not originally reported (BASF SE, 2019). According to REACH Guidance document chapter R.10 Table R.10-1 (Overview of toxicity test endpoints and guidance on derivation of L(E)C50 and NOEC values) an EC10 for a long-term test which is obtained using an appropriate statistical method (usually regression analysis) will be used preferentially. There has been a recommendation within OECD in 1996 to phase out the use of the NOEC, in particular as it can correspond to large and potentially biologically important magnitudes of effect. The advantage of regression method for the estimation of ECx is that information from the whole concentration-effect relationship is taken into account and that confidence intervals can be calculated. These methods result in an ECx, where x is a low effect percentile (e.g. 5-20%). It makes results from different experiments more comparable than NOECs. The recalculation fulfills the required validity criteria.
The 21 -d EC10 was 0.63 mg/L (95% CL: 0.5786 – 0.69 mg/L; nominal, recalculated, BASF SE, 2019). The 21 -d EC20 was determined to be 0.69 mg/L (95% CL: 0.63 – 0.76 mg/L; nominal, recalculated, BASF SE, 2019).
The test concentration used to derive the NOEC (0.625g/l) was measured and maintained within 20% of nominal (maintained within 90-107%) at the given sampling points. Therefore, although the sampling regime is rather limited, as the concentration used to derive the NOEC and ECx values appears to have been well maintained (and is well below the solubility limit), the basing of the endpoint upon nominal concentrations appears reasonable and the study is considered suitable for use in the risk assessment.
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