Reproductive safety evaluation of L-Ergothioneine.
L-Ergothioneine is a naturally occurring histidine-derived betaine (CAS No: 497-30-3) synthesized by bacteria and fungi, and found ubiquitously in plants and animals. It is present in many human foodstuffs. We evaluated the potential reproductive toxicity of L-Ergothioneine in Sprague-Dawley rats. L-Ergothioneine was administered at concentrations of 0.1, 0.3 or 0.9% in diet to F0 males (for 10 weeks before pairing and 3 weeks during pairing) and F0 females (for 13 weeks before pairing, during pairing and gestation, and until day 5 of lactation). Systemic exposure increased with dose-level, but not dose proportionally, suggesting saturation of uptake mechanisms. No clinical signs of toxicity were observed and there were no effects of L-Ergothioneine treatment on mating and reproductive performance or parameters of fertility. All animals mated within a similar number of days and pregnancy rates were uniformly high in control and treated groups. There were no effects of treatment with L-Ergothioneine on the duration of gestation, pre- and post-implantation losses, number of pups delivered and viability index, or on litter parameters (litter size, clinical signs, body weight or sex ratio) and the repartition of found dead/cannibalized pups. In conclusion, L-Ergothioneine was well tolerated and without adverse effects on the reproductive parameters evaluated.
CiToxLAB, Evreux 27005, France. Electronic address: roy.forster@fr.citoxlab.com.
Roy
R
Forster
CiToxLAB, Evreux 27005, France.
François
F
Spézia
CiToxLAB, Evreux 27005, France.
Dominique
D
Papineau
CiToxLAB, Evreux 27005, France.
Caroline
C
Sabadie
Tetrahedron, Vincennes 94300, France.
Irene
I
Erdelmeier
Tetrahedron, Vincennes 94300, France.
Marc
M
Moutet
Tetrahedron, Vincennes 94300, France.
Jean-Claude
JC
Yadan
D000818:Animals; D004305:Dose-Response Relationship, Drug; D004880:Ergothioneine / Q000009:adverse effects* / Q000737:chemistry; D005260:Female; D006801:Humans; D008297:Male; D015394:Molecular Structure; D051381:Rats; D017207:Rats, Sprague-Dawley; D012098:Reproduction / Q000187:drug effects*
D004880:Ergothioneine
Dietary ingredient; Food safety; L-Ergothioneine; Reproductive toxicity