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Captan (Pesticides).

Food Safety (Tokyo, Japan)

|April 2, 2020

Summary

The Food Safety Commission of Japan assessed the fungicide captan, finding it caused adverse effects like duodenal tumors in mice but was not genotoxic. An acceptable daily intake (ADI) and acute reference dose (ARfD) were established for dietary safety.

Area of Science:

Toxicology
Food Safety
Risk Assessment

Background:

Captan (CAS No. 133-06-2) is a phthalimide fungicide.
Previous studies indicated potential adverse effects.
A comprehensive risk assessment was warranted.

Purpose of the Study:

To conduct a risk assessment of captan based on available scientific data.
To determine acceptable daily intake (ADI) and acute reference dose (ARfD) for human consumption.
To evaluate the toxicological profile of captan for dietary risk assessment.

Main Methods:

Review of various toxicological studies including carcinogenicity, genotoxicity, and developmental toxicity.
Identification of the lowest no-observed-adverse-effect level (NOAEL).

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Application of safety factors to establish ADI and ARfD values.

Main Results:

Captan exposure led to suppressed body weight and duodenal mucosal hyperplasia in mice, with increased duodenal adenoma and adenocarcinoma incidence.
No genotoxicity relevant to human health was identified despite some in vitro positive results, suggesting a non-genotoxic mechanism for tumor development.
Developmental toxicity studies showed increased fetal alterations in rabbits and hamsters at maternally toxic doses, but no teratogenicity in rats.
The lowest NOAEL was 10 mg/kg bw/day, leading to an ADI of 0.1 mg/kg bw/day.
The lowest NOAEL for acute oral administration was 30 mg/kg bw/day, resulting in an ARfD of 0.3 mg/kg bw for pregnant women and 3 mg/kg bw for the general population.

Conclusions:

Captan is not considered genotoxic in vivo, and a threshold can be established for risk assessment.
The established ADI and ARfD values provide a basis for ensuring food safety regarding captan residues.
Captan (parent compound only) is the residue definition for dietary risk assessment in agricultural and livestock products.