PATULIN

Overview

CAS number
149-29-1
Functional Class
Food Contaminant
MYCOTOXIN

Evaluations

Evaluation year: 1995

Comments:
At its 35th meeting, the Committee derived a PTWI of 7 µg/kg bw for patulin based on a no-effect level of 0.1 mg/kg bw/day in a combined reproductive toxicity/long-term toxicity/carcinogenicity study in rats. Based on additional information that has become available since the last evaluation, the Committee has reevaluated the PTWI for patulin. As patulin does not accumulate in the body and in the light of the consumption pattern, the PTWI was changed to a PMTDI. Based on a NOEL of 43 µg/kg bw/day and a safety factor of 100, a PMTDI of 0.4 µg/kg bw was established. Submission of the results of a long-term toxicity/carcinogenicity study in a rodent species other than the rat is desirable. Maximum intake levels for children and adults are well below the PMTDI. However, apple juice can occasionally be heavily contaminated and continuing efforts are therefore needed to minimize exposure to this mycotoxin by avoiding the use of rotten or mouldy fruit.
Intake:
Maximum intakes: 0.2 µg/kg bw/d (children), 0.1 µg/kg bw/day (adults)
Tolerable Intake:
PMTDI 0.4 µg/kg bw/d
Meeting:
44
Report: 
TRS 859-JECFA 44/36
Tox Monograph: 
FAS 35-JECFA 44/377

Toxicological study

Pivotal Study:
Combined reproductive toxicity, long-term toxicity/carcinogenicity study (Becci et al., 1981): FDRL Wistar rats (70/sex/group) derived from the F1-generation of a 1-generation reproductive toxicity study were gavaged with 0, 0.1, 0.5, or 1.5 mg/kg bw/day of patulin in citrate buffer by 3 times/week for 24 months. At the highest dose: all males had died by 19 months; 19% of females survived until termination at 24 months. Body weights of males only were reduced at the mid and high dose. No difference in tumour incidence was observed. The NOEL was 0.1 mg/kg bw, administered 3 times weekly, equivalent to 43 µg/kg bw/day.
Animal Specie:
FDRL Wistar rats
Effect:
Decreased weight gain in males
NOEL:
43 µg/kg bw/day
PMTDI:
0.4 µg/kg bw/day
Point of departure:
43 µg/kg bw/day
Previous Years:
1989, TRS 789-JECFA 35/29, FAS 26-JECFA 35/143. PTWI 0.007
1989, TRS 789-JECFA 35/29, FAS 26-JECFA 35/143. PTWI 0.007