OCHRATOXIN A

Overview

Chemical Names

Ochratoxin A

Synonyms

OTA

CAS number

37203-43-3

Functional Class

Food Contaminant
MYCOTOXIN

Evaluations

Evaluation year: 2007

Comments:

At its 37th meeting, the Committee established a PTWI of 112 ng/kg bw, based on deterioration of renal function in pigs, for which the LOEL was 8 μg/kg bw/d, and application of a safety factor of 500. None of the new studies on nephrotoxicity, developmental toxicity, neurotoxicity, or immunotoxicity published since the Committee’s last evaluation would impact the Committee’s previous selection of minimal renal changes in the pig, observed at a dose of 8 μg/kg bw per day (the LOEL), as a critical effect for risk assessment. The Committee therefore retained the previous PTWI of 112 ng/kg bw. The current estimate of overall dietary exposure to ochratoxin A is about 8–17 ng/kg bw/week, which is well below the PTWI. Owing to the very small number of samples contaminated above the highest proposed limit of 20 μg/kg for cereals, such an ML would have very limited impact compared with no ML. The Committee concluded that the use of an ML of 5 or 20 μg/kg would be unlikely to have an impact on dietary exposure to ochratoxin A.

Intake:

8–17 ng/kg bw per week, based on European data concerning ochratoxin contamination in processed cereals

Tolerable Intake:

PTWI 112 ng/kg bw/week

Meeting:

Report:

TRS 947-JECFA 68/59

Tox Monograph:

68th_2007_ochratoxin A.pdf

Toxicological study

Pivotal Study:

Nephrotoxicity study in pigs (Stoev et al., 2001 & 2002): Study 1--Pigs (n=3/sex/group) exposed to diets containing 90, 130 or 180 µg ochratoxin A/kg of diet. Two pigs/group were examined after 3 months. For an additional 2 months, the ochratoxin A concentrations in the diets were raised to 130, 305 or 790 µg/kg. After 3 months, microscopic lesions and changes in haematological and biochemical parameters were observed in all groups. Histological examination (2/group) after 5 months showed proximal tubular degeneration which progressed to renal interstitial proliferation. Study 2--Pigs (n=3/sex/group) given a diet containing ochratoxin A at a concentration of 800 µg/kg for 1 year. Only mild nephropathy was reported, with the same types of lesions reported in the 1st study.

Animal Specie:

Pig

Effect:

Renal proximal tubule degeneration & interstitial nephropathy

LOEL:

8 µg/kg bw/day

PTWI:

112 ng/kg bw/week

Point of departure:

LOEL: 8.0 µg/kg bw/day

Previous Years:

2001, TRS 906-JECFA 56/27, FAS 47/FNP 74-JECFA 56/281. PTWI 0.0001. Given the distribution of ochratoxin A contamination of cereals, application of a limit of 5 or 20 µg/kg would make no significant difference to the average intake. CONTAM 1995, TRS 859-JECFA 44/35