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. 2020 May 13;18(5):e06113. doi: 10.2903/j.efsa.2020.6113

Table C.2.

Studies in pigs used in previous assessments to establish HBGVs

Strain Dose and animals per group Duration/time of observation Main effects observed Effect level Reference
Danish Landrace‐Duroc (♀) Gelatin capsules containing OTA equivalent to 0, 0.2 and 1 mg/kg feed, n = 6 1–5 weeks

  • Decrease in renal enzyme activities of PEPCK and gamma‐GT (0.2 and 1 mg/kg feed)

  • Decrease in TmPAH and TmPAH/CInulin (0.2 and 1 mg/kg feed)

 0.2 mg/kg feed (based on kidney lesions) Krogh et al. (1988), Meisner and Krogh (1986)
Danish Landrace (♀) 0, 0.2, 1, 4 mg/kg feed (corresponding to ~ 8, 40, and 160 μg/kg bw), n = 4–9 3–4 months (i.e. from 20 to 90 kg bw)

  • Increased water consumption & increased serum creatinine and urea (4 mg/kg feed)

  • Increased urinary glucose, decreased reabsorption of glucose, decreased ability to concentrate urine, altered enzymatic activities of GLDH and LAP in renal cortex (1 and 4 mg/kg feed)

  • Renal histopathological changes: tubule dilation with reduced brush boarder, pycnotic nuclei, mitotic figures, desquamation of tubule cells (0.2, 1 and 4 mg/kg bw), degenerative changes, glomerulosclerosis, interstitial fibrosis (1 and 4 mg/kg feed)

  • Decreased TmPAH and TmPAH/CInulin (0.2, 1 and 4 mg/kg feed)

 0.2 mg/kg feed (corresponding to 8 μg/kg bw) (based on kidney lesions) Krogh et al. (1974)
Danish Landrace (♀) 0, 30–50 μg/kg bw (gelatin capsule) (corresponding to 0 and 1 mg/kg feed), n = 3–6 3 months

  • Renal histopathological changes: proximal tubule degeneration, tubular atrophy, interstitial fibrosis

  • Decreased TmPAH/CInulin; decreased ability to concentrate urine, increased urinary glucose

  • Changes in renal enzyme activity of NADH‐TR, SDH, ACP and ALP

 0, 30‐50 μg/kg bw (corresponding to 0 and 1 mg/kg feed) (based on kidney lesions) Krogh et al. (1976, 1979), Elling (1979a, 1979b)
2 years

  • Renal histopathological changes: proximal tubule damage, tubular atrophy, interstitial fibrosis, hyalinised glomeruli

  • Decreased TmPAH and TmPAH/CInulin; decreased ability to concentrate urine, increased glucose excretion

  • Changes in renal enzyme activity of NADH‐TR, SDH, ACP and ALP

 0, 30–50 μg/kg bw (corresponding to 0 and 1 mg/kg feed) (based on kidney lesions) Krogh et al. (1979), Elling (1979b)

ACP: acid phosphatase; ALP: alkaline phosphatase; GLDH: glutamate dehydrogenase; ɣ‐GT: ɣ‐glutamyl transpeptidase; LAP: leucine aminopeptidase; NADH‐TR: NADH‐tetrazolium reductase; OTA: ochratoxin A; PEPCK: cytosolic phosphoenolpyruvate carboxykinase; SDH: succinate dehydrogenase; TmPAH: average maximal tubular excretion of PAH; TmPAH/CInulin: ratio between TmPAH and average renal clearance of inulin.