Animal data derived from dose-response studies, toxicokinetic studies and mechanical studies are used to predict adverse effects of the agent in human. Characteristics of exposed population such as population with large amount of intake or population of high susceptibility are examined in this step. Risk characterization for the agent gives practically an answer to the questions regarding to 1 A level of exposure considered to present minimal or no risk for health effects LOAEL: To minimize or reduce uncertainties in risk analysis, hazard characterization is available for final risk analysis.
An introduction of genotoxic data into evaluation of carcinogenic risk assessment is cited as an example. However, the application of each uncertainty factor is too insufficient to be good predictors for subsequent clinical data or epidemiological studies so far. In the , from a standpoint of preventive medicine, the author began to feel keenly the necessity of the risk assessment to evaluate individually the toxicity of such main biofunction as brain-nerve function, immunofunction and endocrine function.
First, the author began to aim at systematizing and giving each toxicological science an assured status, and further advocated each as brain-neurotoxicology, immunotoxicology, and endocrinotoxicology. These denominations and concept of biofunctional toxicology in the are the first in Japan.
Of each toxicological science, immunotoxicology has made great advancements ever since. Currently, immunotoxicology is recognized as a mature sub discipline of toxicology, and has reached the state at which information on hazard can be applied to risk assessment with the careful consideration of available guidance. Up to now, there are the two major international guidance documents on immunotoxicity risk assessment: The WHO guidance presents how information obtained by immunotoxicity assessment may be applied for risk assessment in the population.
This guidance is the first document published as immunotoxicity risk assessment for chemicals up to now. The guidance states that immunotoxicity risk assessment should be performed according to the same principal approaches as applied in risk assessment for other toxicological end-points, because the immune system or each type of immunotoxicity manifests many special aspects that need specific consideration in risk assessment.
Furthermore, the guidance recommends that a weight of evidence approach is most suited for risk assessment of immunotoxicity, and that the approach should include clinical and epidemiological information, equally as information from animal experiments and other information. Immunotoxicity risk assessment of chemicals is an evaluation of the potential for unintended effects of chemical exposure on the immune system.
These effects manifest as following principal types of immunotoxicity: Such immune dysregulation may lead to many different types of illnesses.
Included among them are illnesses that are associated with a dysfunctional immune system, such as infections, inflammatory diseases, allergic diseases, autoimmune diseases, etc, although all of them are not induced by chemical exposure. For instance, exposure to xenobiotics is associated with immunosuppression manifesting the reduction of resistance to infections, development of autoimmune disease and hypersensitivity responding directly as allergen or enhancing the induction of allergic sensitization. Risk associated with immunostimulation is relatively difficult of the determination.
With the latest advance of immunology, a number of novel immunocompetent cells that play a part in the regulatory mechanisms of cellular immunity, humoral immunity, inflammation and autoimmunity are being found out through characteristic analysis. Unfortunately, however, the current application is insufficient in the practical stage of clinical and environmental immunotoxicity risk assessment.
Kindle Cloud Reader Read instantly in your browser. However, the application of each uncertainty factor is too insufficient to be good predictors for subsequent clinical data or epidemiological studies so far. View or edit your browsing history. Regulatory sections in each chapter focus on data from both the US Food and Drug Administration, as well as data applicable to western European Nations. Would you like to report this content as inappropriate? Currently, immunotoxicology is recognized as a mature sub discipline of toxicology, and has reached the state at which information on hazard can be applied to risk assessment with the careful consideration of available guidance.
Especially in clinical field, there is currently a lack of adequate standardization for immune monitoring tests during clinical trials in immune safety issues and a lack of specific immunotoxicity biomarkers to improve the immune-safety of chemical agent. Most of means used for clinical immunotoxicity risk assessment are those for immunosuppression, and there is little reference to the assessment of immunostimulatory and immunomodulatory compounds, because of lack of the good risk assessment models for detecting their compounds that can translate to clinical risk assessment.
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