Table G.1.
Additional genotoxicity data (in vitro and in vivo) evaluated in FGE.210Rev3Additional genotoxicity data (in vitro)
| Chemical name [FL‐no] | Test system | Test object | Concentrations or doses of substance and test conditions | Result | Reference | Comments |
|---|---|---|---|---|---|---|
| α‐damascone [07.134] | In vitro micronucleus assay | Human peripheral blood lymphocytes |
8, 15, 22.5 and 25 μg/mLa 8, 12, 14 and 15 μg/mLb 5, 8, 9 and 10 μg/mLc |
Equivocal | Covance (2014) | Reliable without restrictions. Equivocal results observed in all treatment conditions |
| In vivo combined micronucleus and comet | Han Wistar rats | 125, 250 and 500 mg/kg bw | Covance (2016) | Reliable without restrictions | ||
| Bone marrow micronucleus assay | Negative | Evidence of bone marrow exposure from a 90‐day toxicity study in rats | ||||
| Comet assay in liver | Positive | In the first experiment, α‐damascone (stored without nitrogen protection) was positive in the comet assay in liver | ||||
| Comet assay in liver | Equivocal | The experiment was repeated with α‐damascone stored under nitrogen gas to prevent oxidation. In this second experiment, there were no statistically significant increases in tail intensity, but a statistically significant (p ≤ 0.05) linear trend was observed | ||||
| Comet assay in duodenum | Negative | α‐Damascone was negative in duodenum, independently on the storage conditions of the testing substance | ||||
| α‐damascone ‘fresh’ sample | Comet assay in liver | Sprague‐Dawley rats | 125, 250 or 500 mg/kg bw | Equivocal | BioReliance (2018a) | Reliable with restrictions. Deviations from GLP observed. One animal was considered as outlier, but no results were presented in the study report |
| α‐damascone ‘aged’ sample | Comet assay in liver | Sprague‐Dawley rats | 125, 250 or 500 mg/kg bw | Inconclusive | BioReliance (2018b) | Not reliable, with deviations from GLP. The mean tail intensity value of the negative control group (3.43 ± 1.46%) is outside the 95% confidence range of the historical negative controls (0.00–0.98%) |
a
3‐h treatment with 21‐h recovery, without S9 metabolic activation.
b
3‐h treatment with 21‐h recovery, with S9 metabolic activation.
c
24‐h treatment with 0‐h recovery.