TABLE D.2 Summary of newly submitted in vivo genotoxicity studies on naringenin (Documentation provided to EFSA No. 2 and 3).
| Chemical name [FL‐no] | Test system in vivo | Test object route | Doses (mg/kg bw per day) | Result | Reliability/comments | Relevance of test system/Relevance of the result | Reference |
|---|---|---|---|---|---|---|---|
|
Naringenin [16.132] |
Micronucleus assay in peripheral blood |
Wistar rats, M Gavage |
500, 1000, 2000 a | Negative | Reliable without restriction. Study performed according to OECD TG 474 and in compliance with GLP | High/High | Eurofins Biopharma (2019a, 2019b) |
| Comet assay in liver and duodenum |
Wistar rats, M Gavage |
Negative | Reliable without restriction. Study performed according to OECD TG 489 and in compliance with GLP | High/High | Eurofins Biopharma (2019a) |
Abbreviations: bw, body weight; GLP, good laboratory practice; M, males; OECD, Organisation for Economic Co‐operation and Development.
Naringenin was administered at 0, 24 and 45 h. Tissues were collected at 3 h after the final administration.