The European Commission's White Paper “Strategy for a Future Chemicals Policy”: A Review

Rogers, Michael D.

doi:10.1111/1539-6924.00317

Cited by 34 publications

(18 citation statements)

References 4 publications

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“…A guidance document developed to support this effort prescribed defined limits on bioaccumulation ( [2]; http://canadagazette.gc.ca/partII/2000/20000329/ pdf/g2-13407.pdf). Proposed legislation in Europe (Registration, Evaluation, and Authorization of Chemicals [REACH] program) could potentially result in similar reviews of tens of thousands of compounds [3,4].…”

Section: Introductionmentioning

confidence: 99%

In vitro‐in vivo extrapolation of quantitative hepatic biotransformation data for fish. II. Modeled effects on chemical bioaccumulation

Nichols

Fitzsimmons

Burkhard

2007

Enviro Toxic and Chemistry

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Hypothetical in vitro biotransformation rate and affinity values for fish were extrapolated to a set of in vivo whole-body metabolism rate constants. A one-compartment model was then used to investigate potential effects of metabolism on chemical bioaccumulation as a function of octanol/water partitioning (Kow). In a second model-based effort, in vitro data were incorporated into a physiologically based toxicokinetic (PBTK) model for fish. The two models predict similar effects on bioaccumulation when calculated in vivo intrinsic clearance values (CL(IN VIVO,INT) are less than 50% of estimated liver blood flow (Q(LIVER). When CL(IN VIVO,INT) approaches Q(LIVER), the PBTK model predicts a greater effect on bioaccumulation than the one-compartment model. This result is attributed to the structure of the PBTK model, which provides for first-pass clearance of chemicals taken up from food. Uncertainties inherent to in vitro-in vivo extrapolations of hepatic metabolism data include the effects of protein binding, inaccurate estimation of in vivo metabolism by in vitro assays, and failure to account for metabolism in other tissues. Model-based predictions of bioaccumulation within a natural setting also must account for possible metabolism at multiple trophic levels. The models described in this study can be used to perform in vitro-in vivo metabolism comparisons with fish, estimate in vitro biotransformation parameters on the basis of measured chemical residues in field-collected animals, and calculate the level of in vitro metabolic activity required to limit bioaccumulation of all compounds to a specified value.

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Section: Introductionmentioning

confidence: 99%

In vitro‐in vivo extrapolation of quantitative hepatic biotransformation data for fish. II. Modeled effects on chemical bioaccumulation

Nichols

Fitzsimmons

Burkhard

2007

Enviro Toxic and Chemistry

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“…However, based on information from the U.S. High Production Volume (HPV) Challenge Program and the European REACH (Registration, Evaluation, Authorization of Chemicals) Program there was a remarkable need for testing the embryotoxic potential of a large number of chemicals [111,112]. In 2001 the European Community published a White Paper on the strategy to carry out risk assessment for about 30,000 existing substances [113]. Since in vivo testing of such number of chemicals would be difficult to perform in short period of time and they would require enormous quantity of animals, there was a strong query for alternative in vitro methods in embryotoxicity assays.…”

Section: Human Esc and Embryotoxicitymentioning

confidence: 99%

Stem Cells in Pharmaceutical Biotechnology

Zuba‐Surma

Józkowicz²,

Dulak³

2011

CPB

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Multiple populations of stem cells have been indicated to potentially participate in regeneration of injured organs. Especially, embryonic stem cells (ESC) and recently inducible pluripotent stem cells (iPS) receive a marked attention from scientists and clinicians for regenerative medicine because of their high proliferative and differentiation capacities. Despite that ESC and iPS cells are expected to give rise into multiple regenerative applications when their side effects are overcame during appropriate preparation procedures, in fact their most recent application of human ESC may, however, reside in their use as a tool in drug development and disease modeling. This review focuses on the applications of stem cells in pharmaceutical biotechnology. We discuss possible relevance of pluripotent cell stem populations in developing physiological models for any human tissue cell type useful for pharmacological, metabolic and toxicity evaluation necessary in the earliest steps of drug development. The present models applied for preclinical drug testing consist of primary cells or immortalized cell lines that show limitations in terms of accessibility or relevance to their in vivo counterparts. The availability of renewable human cells with functional similarities to their in vivo counterparts is the first landmark for a new generation of cell-based assays. We discuss the approaches for using stem cells as valuable physiological targets of drug activity which may increase the strength of target validation and efficacy potentially resulting in introducing new safer remedies into clinical trials and the marketplace. Moreover, we discuss the possible applications of stem cells for elucidating mechanisms of disease pathogenesis. The knowledge about the mechanisms governing the development and progression of multitude disorders which would come from the cellular models established based on stem cells, may give rise to new therapeutical strategies for such diseases. All together, the applications of various cell types derived from patient specific pluripotent stem cells may lead to targeted drug and cellular therapies for certain individuals.

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“…Since the 1980s, the government of Japan and organizations such as the Japanese Standards Association (JSA), the Japan Industrial Safety and Health Association (JISHA), and the Japan Association of Safety and Health Consultants (JASHC) have repeatedly organized committees or working groups to form advisory panels composed of professionals, service providers, academics, lawyers, and government officers to review and discuss international movements and their efficacy in encouraging voluntary actions of enterprises to promote occupational health and safety (Table 1) [2-7]. In these committees, notions of a risk assessment and occupational health and safety management system (OHSMS) were admit ted as promising policies and expected to further reduce the incidence rate of industrial accidents and occupational diseases.…”

Section: Legislative Stipulations On Risk Assessments At Workplaces Imentioning

confidence: 99%

Occupational Health Policies on Risk Assessment in Japan

Horie¹

2010

Safety and Health at Work

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Industrial Safety and Health Law (ISH Law) of Japan requires abnormalities identified in evaluations of worker health and working environments are reported to occupational physicians, and employers are advised of measures to ensure appropriate accommodations in working environments and work procedures. Since the 1980s, notions of a risk assessment and occupational safety and health management system were expected to further prevent industrial accidents. In 2005, ISH Law stipulated workplace risk assessment using the wording "employers shall endeavor." Following the amendment, multiple documents and guidelines for risk assessment for different work procedures were developed. They require ISH Laws to be implemented fully and workplaces to plan and execute measures to reduce risks, ranking them from those addressing potential hazards to those requiring workers to wear protective articles. A governmental survey in 2005 found the performance of risk assessment was 20.4% and common reasons for not implementing risk assessments were lack of adequate personnel or knowledge. ISH Law specifies criminal penalties for both individuals and organizations. Moreover, under the Labor Contract Law promulgated in 2007, employers are obliged to make reasonable efforts to ensure employee health for foreseeable and avoidable risks. Therefore, enterprises neglecting even the non-binding provisions of guidelines are likely to suffer significant business impact if judged to be responsible for industrial accidents or occupational disease. To promote risk assessment, we must strengthen technical, financial, and physical support from public-service organizations, encourage the dissemination of good practices to reduce risks, and consider additional employer incentives, including relaxed mandatory regulations.

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The European Commission's White Paper “Strategy for a Future Chemicals Policy”: A Review

Cited by 34 publications

References 4 publications

In vitro‐in vivo extrapolation of quantitative hepatic biotransformation data for fish. II. Modeled effects on chemical bioaccumulation

In vitro‐in vivo extrapolation of quantitative hepatic biotransformation data for fish. II. Modeled effects on chemical bioaccumulation

Stem Cells in Pharmaceutical Biotechnology

Occupational Health Policies on Risk Assessment in Japan

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