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. 2020 Aug 11;18(8):e06222. doi: 10.2903/j.efsa.2020.6222

Table 11.

Repeated dose oral toxicity studies with defined mixtures of glycoalkaloids (GAs) (α‐solanine and α‐chaconine) from edible parts of S. tuberosum

Test compound Species Dose route Doses Observed effects Highest dose with no effect GA (α‐solanine/α‐chaconine) (mg/kg bw per day) Lowest dose with effect GA (α‐solanine/α‐chaconine) (mg/kg bw per day) Reference
Potatoes containing 6.4 mg TGA (20 mg α‐solanine; 37 mg α‐chaconine) per kg fw, admixed as powder to dietb

Swiss‐Webster mice (sex n.r)

No/sex/group: 4–5

Oral application (diet): 0, 1, 5, 10, 20 or 40% potato powder in the diet with approximately 0, 2.9, 14.6, 29.1, 58.2 or 116.4 mg TGA/kg diete (equivalent to 0, 0.6, 5.8, 11.6 and 23.2 mg TGA/kg bw per dayd)

Duration: 7 and 14 days

↑ absolute and relative pancreas weight ~ 11.6 (3.63/6.71) ~ 23.2 (7.25/13.4) Friedman (1992)
α‐Solanine:α‐chaconine (1:1)a

Syrian hamster (M)

No/sex/group: 2

Gavage: 0, 5, 10, 25 or 50 mg GA/kg bw per day

Duration: 3 days

No effect 50 (25/25) Phillips et al. (1996)
α‐Solanine:α‐chaconine (1:2.5)a

Golden Syrian hamster d No/sex/group: 4–8

Gavage: 0, 75 or 100 mg/kg bw per day

Duration: 5 days

Lethality (in 25%)

↓ food intake

↓ bw gain

↓ relative liver weight

↑ relative adrenal weight

↑ HGB, HCT

↑ RBC

↑ serum creatine

75 (21.4/53.6)

75 (21.4/53.6)

75 (21.4/53.6)

75 (21.4/53.6)

75 (21.4/53.6)

75 (21.4/53.6)

100 (28.6/71.4)

75 (21.4/53.6)

100 (28.6/71.4)

75 (21.4/53.6)

100 (28.6/71.4)

100 (28.6/71.4)

Langkilde et al. (2008)

For single compound controls, see Table 11

α‐Solanine:α‐chaconine (1:3.7)a

Golden Syrian hamster d No/sex/group: 4

Gavage: 0, 0.1, 0.33, 1, 3.3, 10 or 33.3 mg/kg bw per day

Duration: 28 days

↑WBC and RBC

↓albumin, urea and plasma proteins

↑serum AST

Distended stomach and intestine

10f (2.1/7.9)

10f (2.1/7.9)

10f (2.1/7.9)

10f (2.1/7.9)

33 (7/26)

33 (7/26)

33 (7/26)

33 (7/26)

Langkilde et al. (2009)
α‐Solanine:α‐chaconine (1:70)a

Golden Syrian hamster d No/sex/group: 4

Gavage: 0, 0.1, 0.33, 1, 3.3, 10 or 33.3 mg/kg bw per day

Duration: 28 days

Mortality (25%)

↑WBC and RBC

↓albumin, urea and plasma proteins

↑serum AST

Distended stomach and intestine

10 (0.1/9.9)

10f (0.1/9.9)

10f (0.1/9.9)

10f (0.1/9.9)

10f (0.1/9.9)

33.3 (0.5/32.8)

33.3 (0.5/32.8)

33.3 (0.5/32.8)

33.3 (0.5/32.8)

33.3 (0.5/32.8)

Langkilde et al. (2009)

α‐Solanine:α‐chaconine (1:3.1)

S. tuberosum Desiree (added to chow as freeze‐dried powder)b, c

Golden Syrian hamster d No/sex/group: 10

Diet: TGA at 0, 6.9, 13.8, 20.6 or 33d mg/kg bw per day

Duration: 90 days

No effects 33 (8/25) Langkilde et al. (2012)

α‐Solanine:α‐chaconine (1:25.5‐26)

S. tuberosum SGT9‐2 (added to chow as freeze‐dried powder) and spiked with GA from commercial sourceb

Golden Syrian hamster d

No/sex/group: 10

Diet: TGA at 0, 6.9, 13.8 or 20.6 mg/kg bw per day

Duration: 90 days

No effects 20.6 (1.0/19.6) Langkilde et al. (2012)
α‐Solanine:α‐chaconine (1:25.5–26) from S. tuberosum SGT 9‐2 (added to chow as freeze‐dried powder)b

Golden Syrian hamster d No/sex/group: 10

Diet: TGA at 0 or 8.6 mg/kg bw per day

Duration: 90 days

No effects 8.6 (0.3/8.5) Langkilde et al. (2012)

F: females; M: males; n.r.: not reported; TGA: total GA content; AST: aspartate aminotransferase; WBC: white blood cells; RBC: red blood cells; HCT: haematocrit; HBG: haemoglobin.

a

Chemical standard obtained from a commercial supplier, with high purity (95% pure or higher).

Chemical standard obtained by in‐house isolation from plant material, and checked for purity (95% pure or higher).

Poorly characterised chemical standard (e. g. purity or composition not defined) or with a non‐ or only partly purified extract or material for which the GA composition and concentration is given.

b

A non‐ or only partly purified extract or material for which the GA composition and concentration is given.

c

Spiked with GAs from commercial source.

d

Applying EFSA default values

e

Anticipating 78% water content of potatoes, the GA content would be 291 mg TGA, 91 mg α‐solanine and 168 mg α‐chaconine per kg potato powder.

f

Approximative values read from the figures of the study.