Table C.2.

Details of studies reporting on the toxicokinetics of glycoalkaloids (GAs) in humans

Test compound	Study design (subjects, doses, administration routes, study duration)	Parameters	Reference
α‐solanine, α‐chaconine and solanidine	7 healthy male adults Treatment with a portion of peeled mashed potatoes containing 200 mg TGAs/kg (82 and 118 mg/kg for α‐solanine and α‐chaconine, respectively), adjusted to reach a dose of 1 mg TGAs/kg bw The study subjects were instructed to refrain from eating potatoes and potato products as from 48 h before and up to 25 h after the exposure Blood was sampled prior to the exposure and 1, 2, 3, 4, 5, 8 and 25 h following the exposure Levels of α‐solanine, α‐chaconine and solanidine in serum were measured via HPLC analysis	Kinetic in blood serum (Cmax, Tmax, t1/2)	Hellenäs et al. (1992)
α‐solanine, α‐chaconine and solanidine	6 male and 8 female healthy volunteers (age range: 18–45 years old) Dietary rules to refrain from other products containing GAs were followed as from 72 h prior to the treatment Treatments: 0.30, 0.50 or 0.70 mg TGA/kg bw in 200 mL aqueous solutions (2 subjects/dose group). The solutions contained 50% α‐solanine and 50% of α‐chaconine 0.95, 1.10 or 1.25 mg total TGA/kg bw in portions of a mashed potato meal (3, 3 and 2 subjects/dose group, respectively). The GA content of the potato meal was 51% for α‐solanine and 49% for α‐chaconine. Blood was withdrawn 1 h and 30 min before treatment and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56, 72 and 96 h after treatment Serum α‐solanine, α‐chaconine and solanidine levels were measured by HPLC analysis	Kinetic in blood serum (Cmax, Tmax, t1/2)	Mensinga et al. (2005)
[3H]‐solanidine (tritiated in the aglycone moiety at carbon atoms adjacent to the nitrogen atom)	Two male and one female volunteers Treatment via a single i.v. injection (doses not reported) Blood was sampled at various times up to 150 h Urine was collected at 2, 4, 8 and 12 h Feces were collected as individual voidings The distribution of solanidine in liver was studied in five post‐mortem liver samples. Four solanidine fractions were extracted: Free‐solanidine was extracted with dichloromethane from liver homogenates. Beta‐glucuronide conjugates were extracted following treatment with β‐glucuronidase subsequent extraction with dichloromethane Glycoside fraction was isolated following treatment with mixed glycosidases and subsequent extraction with dichloromethane Finally, the residual aqueous fraction was treated with hydrochloric acid and extracted with dichloromethane (acid‐hydrolysed fraction)	Kinetic in plasma, urine and feces Distribution of solanidine in liver	Claringbold (1982)
Solanidine	34 human donors (7 males and 27 females), randomly selected from a hospital clinic Development of a radioimmunoassay method to quantify solanidine in human plasma. Serum from rabbits immunised using a solanine‐BSA conjugated was used. 100% cross reactivity was found for solanidine, α‐solanine, α‐chaconine and desmissidine. A chloroform extraction procedure showed allowed the specific quantification of solanidine	Determination of solanidine in plasma	Matthew et al. (1983)
Solanidine	57 volunteers (30 males, age range: 18–44 years old; 27 females, age range: 16–62 years old) Solanidine levels in plasma were analysed using the radioimmune assay developed by Matthew et al. (1983) The study subjects were asked to maintain their standard diet during winter (November–December), with the exclusion of two male volunteers who maintained a potato‐free diet for several weeks while their serum was regularly analysed for solanidine levels The consumption of potatoes and potato products of 33/57 subjects was recorded for one month	Determination of solanidine in plasma	Harvey et al. (1985a)
Solanidine, TGA	Two groups of volunteers: From UK: 18 males (18–41 years old), and 15 females (19–63 years old) from Sweden: 5 males (31–41 years), and 5 females, 61–67 years) GAs levels were analysed using a radioimmuno method adapted from Matthew et al. (1983) Exposure to GAs through normal diet (during summer), with the exclusion of three Swedish volunteers (2 m and 1 f), who had daily consumption of two potato cultivars known to be high in GAs (‘Ulster Chieftain’ and ‘SV72118’) for a week before serum and saliva sampling Blood and saliva samples were collected from all volunteers and analysed for the presence of solanidine (upon chloroform extraction) or total GA levels	Solanidine and total GA levels in blood and saliva	Harvey et al. (1985b)

HPLC: high‐performance liquid chromatography.