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Folpet (Pesticides).

Food Safety (Tokyo, Japan)

|April 2, 2020

Summary

The Food Safety Commission of Japan assessed the fungicide folpet, finding no neurotoxicity or fertility issues. While tumors were observed in mice, a genotoxic mechanism was unlikely, allowing for a safe daily intake and reference dose for pregnant women.

Area of Science:

Food safety
Toxicology
Risk assessment

Background:

Folpet (CAS No. 133-07-3) is a phthalimide fungicide.
Previous studies indicated potential adverse effects and carcinogenicity in animal models.
A comprehensive risk assessment was required to establish safe consumption levels.

Purpose of the Study:

To conduct a risk assessment of folpet.
To determine the acceptable daily intake (ADI) and acute reference dose (ARfD).
To establish the residue definition for dietary risk assessment.

Main Methods:

Review of various toxicological studies, including carcinogenicity and developmental toxicity.
Identification of the lowest no-observed-adverse-effect level (NOAEL).
Application of safety factors to establish ADI and ARfD.

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Main Results:

Major adverse effects included hyperkeratosis in rats and duodenal mucosal hyperplasia in mice.
No neurotoxicity or adverse effects on fertility were detected.
Increased duodenal adenoma and adenocarcinoma incidence in mice, but deemed unlikely genotoxic.
No teratogenicity or fetal toxicity observed at non-maternally toxic doses.
Lowest NOAEL was 10 mg/kg bw/day.
ADI established at 0.1 mg/kg bw/day.
ARfD for pregnant women established at 0.1 mg/kg bw/day.

Conclusions:

Folpet is unlikely to be genotoxic in humans, despite some in vitro results.
A threshold for risk assessment could be established.
Folpet (parent compound) is the residue definition for dietary risk.
Safe consumption levels (ADI and ARfD for pregnant women) were determined based on NOAELs and safety factors.