Table 1.
Summary of the toxicological profile of the metabolites
| Metabolite | Source | Genotoxicity | Reference values (RV) |
|---|---|---|---|
|
OXA (and OXA S‐enantiomer CGA351916) |
GW | Unlikely to be genotoxic | Reference values of S‐metolachlor apply |
|
ESA CGA354743 (a) (and ESA S‐enantiomer, CGA376944) |
GW | Equivocal results for mutagenicity and clastogenicity (data gap) | No conclusion, pending data gap in genotoxicity |
| NOA413173 (a) | GW | Equivocal results for clastogenicity in vitro, lack of investigation of the aneugenicity potential (data gap) | No conclusion, pending data gap in genotoxicity |
| CGA368208 | GW | Negative for mutagenicity and clastogenicity, aneugenicity not investigated (data gap) | No conclusion, pending data gap in genotoxicity |
| CGA50720 | GW | Unlikely to be genotoxic | No conclusion |
| CGA357704 | GW | Unlikely to be genotoxic | No conclusion |
| SYN548164 [ammonium salt of SYN542491] | [GW] | Unlikely to be genotoxic | No conclusion |
| NOA436611 | GW | Negative for mutagenicity and clastogenicity, aneugenicity not investigated (data gap) | No conclusion |
| SYN548163 [ammonium salt of SYN542489] | [GW] | Negative for mutagenicity and clastogenicity, aneugenicity not investigated (data gap) | No conclusion |
| SYN542492 | GW | Unlikely to be genotoxic | No conclusion |
| SYN542488 | GW | Equivocal results for mutagenicity in vitro (data gap) | No conclusion |
| SYN548165 [ammonium salt of SYN542607] | [GW] | Negative for mutagenicity and clastogenicity, aneugenicity not investigated (data gap) | No conclusion |
(a)
It was noted during the MS written procedure on the draft conclusion that new genotoxicity studies are available and have been submitted for national assessment in France. Based on a national assessment of these additional studies, it was concluded that both metabolites are unlikely to be genotoxic (see EFSA, 2023).