Interagency Regulatory Liaison Group Workshop on Reproductive Toxicity Risk Assessment

doi:10.2307/3430236

Environmental Health Perspectives

1986

DOI: 10.2307/3430236

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Interagency Regulatory Liaison Group Workshop on Reproductive Toxicity Risk Assessment

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1992

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Cited by 2 publications

References 74 publications

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Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Chen

Gaylor

1992

Teratology

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A large-scale developmental toxicology study of 2,4,5-trichlorophenoxyacetic acid was conducted in four inbred strains and one outbred strain of mice. The most significant developmental effects observed were reduced fetal weight and increased incidences of cleft palate (malformation) and prenatal death (deaths/resorptions). The correlation coefficients among the proportion of deaths/resorptions, proportion of malformations, average fetal weights, and number of viable fetuses were investigated, with each variable measured on a per-litter basis. Generally, the correlation coefficients between average fetal weight and number of viable fetuses were negative for the control and low-dose groups in the C57BL/6, C3H/He, and BALB/c strains. Overall, the correlation coefficients between proportion of malformations and number of viable fetuses were not significant. The correlation coefficients between proportion of malformations and average fetal weight were negative for all but one case. The correlations were weak in the control and low-dose groups, in which the malformation rates were very low, and were strong in the high-dose groups. The correlation coefficients between proportion of deaths/resorptions and proportion of malformations were generally positive at the high doses; some negative correlations were observed in control and low-dose groups. The correlation coefficients between proportion of deaths/resorptions and average fetal weight were negative for the A/JAX and CD-1 strains. In summary, the strongest relationship observed was the negative correlation between fetal weight and malformation.

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Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Chen

Gaylor

1992

Teratology

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Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology¹

1988

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The qualitative and quantitative evaluation of risk in developmental toxicology has been discussed in several recent publications. A number of issues still are to be resolved in this area. The qualitative evaluation and interpretation of end points in developmental toxicology depends on an understanding of the biological events leading to the end points observed, the relationships among end points, and their relationship to dose and to maternal toxicity. The interpretation of these end points is also affected by the statistical power of the experiments used for detecting the various end points observed. The quantitative risk assessment attempts to estimate human risk for developmental toxicity as a function of dose. The current approach is to apply safety (uncertainty) factors to the no observed effect level (NOEL). An alternative presented and discussed here is to model the experimental data and apply a safety factor to an estimated risk level to achieve an "acceptable" level of risk. In cases where the dose-response curves upward, this approach provides a conservative estimate of risk. This procedure does not preclude the existence of a threshold dose. More research is needed to develop appropriate dose-response models that can provide better estimates for low-dose extrapolation of developmental effects.

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Interagency Regulatory Liaison Group Workshop on Reproductive Toxicity Risk Assessment

Cited by 2 publications

References 74 publications

Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology¹

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Interagency Regulatory Liaison Group Workshop on Reproductive Toxicity Risk Assessment

Cited by 2 publications

References 74 publications

Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Correlations of developmental end points observed after 2,4,5‐trichlorophenoxyacetic acid exposure in mice

Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology1

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Issues in Qualitative and Quantitative Risk Analysis for Developmental Toxicology¹