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Advisory Committee on Health Effects of Endocrine Disruptors
The Supplement II to the Intermediary Report
1.1.3

 

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(c) In vivo screening (iii)
In order to confirm the hormonal activities found in the in silico and in vitro tests described above in the living body, the uterine hypertorphy test for substances with estrogen-like activities and the Hirschberger test for those with androgen-like activities were performed. Analysis by the former technique of 27 samples of existing chemicals and food-related substances were completed, as well as the latter test for five substances.3
In addition, an improved version of the OECD Test Guideline 407 (iterated administration for 28 days) was tested for the effectiveness in screening with thyroid-related activities taken into account.3
As in (ii) above, substances chosen for study for establishment of guidelines and evaluation criteria (potential positives) are those exist in the natural environment or the environment of human life, for which any endocrinological effect has been observed in wildlife or experimentally found. The screening method for these substances should be capable of determining the intensity of the effect with precisions sufficient for elucidation of the mechanism of action. The methods that meet this requirement are to be proposed for domestic and/or international (pre-)validation, through which the guidelines will be finalized.

(2) Priority list4
The priority list is being augmented by the results of the screening tests described above.5

(3) Definitive studies
The methodology of the definitive studies should be improved to overcome the limitations of the conventional multi-generation reproductive toxicity tests. In response to this requirement, the lifelong test on rodents is under development, in which a series of toxicity parameters (including those related to disruption of the homeostatic regulatory systems, e.g. nerve, behavior, and immune systems, and their maturation (see Figure), beyond those used in the conventional multi-generation reproductive tests) are evaluated comprehensively throughout the life (including genesis, development, maturation and aging).
Exposure to bisphenol A during pregnancy and lactation was used as the model in studies on nerve and behavioral systems. Evaluation and mechanism of action of effects on behavior via the dopamine and serotonin (5-HT) nerve systems, evaluation of effects on higher nerve functions using operand conditioning of mice, and analysis of effects on the sexual differentiation of the brain belong to this category.

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3 Report of studies supported by the Health and Labour Sciences Research Grants (led by Kiyoshi Imai)
4 Priority List of Chemical Substances for Definitive Studies for Risk Evaluation
5 Report of studies supported by the Health and Labour Sciences Research Grants (led by Jun Kanno)
 

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