Oxolinic Acid (Pesticides/Veterinary Medicinal Products)

Area of Science:

• Food safety
• Toxicology
• Risk assessment

Background:

• Oxolinic acid is an antimicrobial agent with a quinoline structure.
• The Food Safety Commission of Japan (FSCJ) conducted a risk assessment based on submitted documents and additional residue data.

Purpose of the Study:

• To conduct a comprehensive risk assessment of oxolinic acid.
• To evaluate potential adverse effects and establish safety guidelines.

Main Methods:

• Review of submitted data including animal and plant fate, residue data, and various toxicity studies (subacute, chronic, reproductive, developmental, genotoxicity).
• Identification of the lowest observed adverse effect level (NOAEL) from acute neurotoxicity studies in rats.

Main Results:

• Major adverse effects included suppressed body weight gain, testicular interstitial cell hyperplasia, ovarian organ weight increase, neurological symptoms, and behavioral changes.
• No adverse effects were noted for fertility, teratogenicity, or genotoxicity.
• The lowest NOAEL was determined to be 6 mg/kg bw.

Conclusions:

• An acute reference dose (ARfD) of 0.06 mg/kg bw was established by applying a safety factor of 100 to the NOAEL.
• The assessment provides crucial data for ensuring the safe use of oxolinic acid.