Table 15.

Developmental toxicity studies on glycoalkaloids (GAs) (α‐tomatine) and aglycones (tomatidine, solasodine, dihydrosolasodine) from edible parts of food plants other than S. tuberosum

Test compound	Species, experimental design and doses	Observed effects	Highest dose with no effect (mg/kg bw per day)		Lowest dose with effect (mg/kg bw per day)		Reference
			Mother	Offspring	Mother	Offspring
α‐Tomatine
α‐Tomatined	Pregnant Simonsen hamsters No/groups: 34 dams Gavage on GD8 0, 530 mg/kg bw per day Sacrifice on GD15	Maternal death 6% deformed littersg from surviving dams			530	530	Keeler et al. (1990)
Tomatidine
Tomatidinec,e	Pregnant Syrian hamsters No/groups: 15–24 pregnant dams Gavage on GD8 0, 1,184, 2,664 mg/kg bw per day Sacrifice on GD15	No effects	2,664	2,664			Keeler et al. (1976)
Tomatidinee	Swiss Webster time pregnant/time mated (not clear) mice No/group: 23 pregnant mice Diet. Exposure GD4–18 2.4 mmol/kg diet (equivalent to 167 mg/kg bw per day)	↓maternal bw ↑maternal relative liver weight			167		Friedman et al. (2003a)
Solasodine
Solasodinec	Pregnant Syrian hamsters No/group: 11–50 dams per group 0, 1,184, 1,480 and 1,628 mg/kg bw per day gavage on GD7, sacrifice on GD15 0, 1,184 and 1,480 mg/kg bw on GD8, sacrifice on GD15	GD7 exposure: Maternal death 25% abnormal littersh 5% abnormal offspring GD8 exposure: Maternal death 36% abnormal littersh 6% abnormal offspring			1,184 1,184	1,184 1,184 1,184 1,184	Keeler et al. (1976)
Solasodinec	Pregnant Syrian hamsters No/group: 8 litters Gavage on GD8 3.4 mmol/kg bw (or 1,400 mg/kg bw)f Sacrifice on GD15	75% abnormal littersh 29% abnormal fetuses (encephalocele, exencephaly, anophthalmia)				1,400 1,400	Gaffield and Keeler (1993)
Solasodinea	Swiss Webster time pregnant/time mated (not clear) mice No/group: 45 pregnant females Diet. Exposure GD4–18 2.4 mmol/kg diet (equivalent to 156 mg/kg bw per day)	↓ maternal bw ↓ maternal feed intake ↑ maternal relative liver weight ↓ litter weight ↓ litter weight/bw ↓ average fetus weight			156 156 156	156 156 156	Friedman et al. (2003a)
Dihydrosolasodine
Dihydrosolasodineb (Soladulcidine)	Pregnant Syrian hamsters No/group: 11 litters Gavage on GD8 3.4 mmol/kg bw (1,400 mg/kg bwf) Sacrifice on GD15	45% abnormal littersh 6% abnormal fetuses (encephalocele, cebocephaly, exencephaly, anophthalmia)				1,400 1,400	Gaffield and Keeler (1993)

GD: gestational day; MW: molecular weight (in g/mol); bw: body weight.

^aChemical standard obtained from a commercial supplier of high purity (95% pure or higher).

^bChemical standard obtained by in‐house synthesis, and checked for purity (95% pure or higher).

^cChemical standard obtained from a commercial supplier, purity not stated.

^dChemical standard obtained from a commercial supplier, may contain dehydrotomatine as an impurity.

^eChemical standard obtained from a commercial supplier, may contain dehydrotomatidine as an impurity.

^fDoses as reported by the authors in the original publication.

^gPercentage of litters containing at least one malformed fetus.

^hNo definition given on whether this refers to the litters or to individuals in the litter.