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A benchmark dose analysis for sodium monofluoroacetate (1080) using dichotomous toxicity data
Natalia M Foronda1, Jefferson Fowles, Nerida Smith
1Ministry of Health, Wellington, New Zealand. natalia_foronda@moh.govt.nz
Regulatory Toxicology and Pharmacology : RTP
|September 13, 2006
Summary
The benchmark dose (BMD) approach offers improved risk assessment for sodium monofluoroacetate (1080) compared to the NOAEL method. BMD estimates for cardiomyopathy and testicular toxicity were comparable to NOAEL values.
Area of Science:
- Toxicology
- Risk Assessment
- Environmental Health
Background:
- Current risk assessment for sodium monofluoroacetate (1080) relies on the no-observed-adverse-effect-level (NOAEL) approach.
- The NOAEL approach may not fully capture dose-response relationships, potentially leading to suboptimal risk assessment values.
Purpose of the Study:
- To investigate the feasibility of using the benchmark dose (BMD) approach as an alternative to NOAEL for 1080 risk assessment.
- To compare BMD estimates with NOAEL values for critical toxicological endpoints.
Main Methods:
- Utilized toxicological data for cardiomyopathy, testicular toxicity, and teratogenic effects of 1080.
- Applied Weibull, probit, and quantal linear models to estimate BMD and BMD lower confidence limits (BMDLs) at a 10% benchmark response (BMR).
- Assessed model fit using chi-squared tests and selected the best model using Akaike's Information Criterion (AIC).
Main Results:
- All tested models demonstrated good fit for the toxicological endpoints.
- BMDL estimates were generally slightly higher but comparable to NOAEL values.
- Specific BMD(10) and BMDL(10) values were determined for cardiomyopathy (0.21 mg/kg bw) and testicular effects (0.10 mg/kg bw).
Conclusions:
- The BMD approach provides a more robust representation of dose-response relationships for 1080 toxicity.
- BMD estimates support the refinement of tolerable daily intake (TDI) calculations for 1080.
- This study advocates for the adoption of the BMD approach in regulatory risk assessment for 1080.
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