Table F.2.
Summary of Additional Genotoxicity Data submitted for FGE.203Rev2 in vivo
| FL‐no | Chemical name | Test system in vivo | Test object route | Dose mg/kg bw per day | Result | Reference | Comments |
|---|---|---|---|---|---|---|---|
| 05.057 | Hexa‐2(trans),4(trans)‐dienal | Micronucleus assay in bone marrow and peripheral blood | Han Wistar rats (males) Oral gavage | 0 (corn oil), 88, 175 and 350 | Negative | Whitwell (2016a) | Reliable without restrictions. Study performed in accordance with OECD TG 474 |
| Micronucleus assay in bone marrow and peripheral blood | Han Wistar rats (males) Intraperitoneal | 0 (corn oil), 19, 38 and 75 | Negative | Whitwell (2016b) | Reliable without restrictions. Study performed in accordance with OECD TG 474 | ||
| Transgenic rodent gene mutation assay (cII gene), liver and forestomach |
Big Blue® B6C3F1 male mice Oral gavage |
0 (corn oil), 10, 30, 90 and 120 | Negative | McKeon and Ciubotaru (2016) | Reliable without restrictions. Study performed in accordance with OECD TG 488 | ||
| 05.140 | Deca‐2(trans),4(trans)‐dienal | Micronucleus assay in bone marrow and peripheral blood | Han Wistar rats (males) Oral gavage | 0 (corn oil), 350, 700 and 1,400 | Negative | Keig‐Shevlin (2016a) | Reliable without restrictions. Study performed in accordance with OECD TG 474 |
| Micronucleus assay in bone marrow and peripheral blood | Han Wistar rats (males) Intraperitoneal | 0 (corn oil), 25, 50 and 100 | Negative | Keig‐Shevlin (2016b) | Reliable without restrictions. Study performed in accordance with OECD TG 474 |
bw: body weight; OECD: Organisation for Economic Co‐operation and Development; TG: Test Guideline.