| Study No. B18674 (Unpublished, 2019a) |
Bacterial reverse mutation test (GLP, OECD TG 471) |
Salmonella Typhimurium TA98, TA100, TA1535, TA1537 and E. coli WP2uvrA (pKM101) |
313, 625, 1,250, 2,500 and 5,000 µg/plate (absence and presence of S9 mix) |
No reproducible or dose-related increases in revertant colony numbers over control counts were observed with any of the strains following exposure to 2’-FL at any concentration. |
| Study No. B18675 (Unpublished, 2019b) |
In vitro mammalian chromosomal aberration test (GLP, OECD TG 473) |
Chinese Hamster Lung (CHL/IU) cells |
1,250–5,000 µg/mL (absence and presence of S9 mix |
The percentage of micronuclei was not significantly increased in any of the test substance concentrations. |
| Study No. 3267-292 (Unpublished, 2021) |
In vitro human lymphocyte micronucleus test (GLP, OECD TG 487) |
Blood from healthy donors |
2,500–5,000 µg/mL (absence and presence of S9 mix) |
The incidence of micro nucleated cells and the ratio of polychromatic erythrocytes to total erythrocytes in the NF treated groups was not statistically significantly different from the negative control group. |
| Study No. B18676 (Unpublished, 2019c) |
In vivo micronucleus test (GLP, OECD TG 474) |
Mouse, CrlOri:CD1(ICR), |
2,500, 5,000, 7,500 mg/kg (oral administration via gastric intubation twice at 24-h intervals |
A statistically significant increase in chromosomal aberrations was noted, but the increase was still within the historical control values of the laboratory. The NF did not induce other statistically significant increases in the frequency of chromosomal aberrations |