3-generation reproductive toxicity study |
Mice |
0/1,500/6,000 males 0/1,800/7,200 females |
No effects, also no brain lesions in histopathology |
>6,000 |
[47] |
|
OECD TG 416 2-generation reproductive toxicity |
Rats |
0/939/3,131 males 0/1,039/3,496 females |
No effects |
>3,131 |
[53] |
|
OECD TG 414 Pre-natal developmental toxicity study |
Rats |
0/302/898/ 3,019 from GD 6-20 pregnancy |
No effects |
>3,019 |
[54] |
|
Developmental neurotoxicity study |
Rats |
0/1,900/3,700/5,300 males, 0/1,600/3,200/5,000 females in the pre-breeding period |
High-dose: delayed early swimming development, diminished rearing frequency in open field, altered active avoidance acquisition and extinction, and prolonged day-2 passive avoidance retention |
3,200 |
[3] |
|
Developmental neuro behavior study |
Rats |
0 and 10,000 GD 7-20 pregnancy |
EFSA [2 no effects when corrected for multiple testing |
>10,000 |
[55, 56] |