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Toxicity value for 3-monochloropropane-1,2-diol using a benchmark dose methodology.

Myungsil Hwang¹, Eunkyung Yoon, Jayoung Kim

¹Division of Risk Assessment, Department of Risk Assessment Research, National Institute of Toxicological Research, Korea FDA, 5 Nokbun-dong, Eunpyung-ku, Seoul 122-704, Republic of Korea.

Regulatory Toxicology and Pharmacology : RTP

|January 10, 2009

Summary

3-Monochloropropane-1,2-diol (3-MCPD), a food contaminant, can be nephrotoxic and carcinogenic. Benchmark dose analysis identified a safe daily intake level for humans based on kidney effects in rats.

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Area of Science:

Toxicology
Food Safety
Risk Assessment

Background:

3-Monochloropropane-1,2-diol (3-MCPD) is a food contaminant formed during acid hydrolysis.
3-MCPD exhibits nephrotoxicity and carcinogenicity in animal studies, with kidneys identified as a primary target organ.

Purpose of the Study:

To determine a point of departure for deriving tolerable daily intakes (TDIs) of 3-MCPD.
To apply benchmark dose (BMD) methodology to rat data for risk assessment.

Main Methods:

Dose-response data for renal tubular hyperplasia in male and female rats exposed to 3-MCPD for 2 years were analyzed.
Seven different models were used to estimate BMDs and BMDLs, with model selection based on Akaike's Information Criterion (AIC).

Main Results:

The study calculated BMD(10) and BMDL(10) values for male rats as 1.21 and 0.87 mg/kg bw/day, respectively.
For female rats, the calculated BMD(10) and BMDL(10) were 26.31 and 19.47 mg/kg bw/day, respectively.
The BMDL(10) of 0.87 mg/kg bw/day in male rats was identified as the critical endpoint.

Conclusions:

The BMDL(10) of 0.87 mg/kg bw/day from male rat data is proposed as the point of departure for establishing the human TDI for 3-MCPD.
This study provides a quantitative basis for setting safe exposure limits for 3-MCPD in food.
Renal tubular hyperplasia is confirmed as a sensitive endpoint for 3-MCPD toxicity assessment.