Treffer 1 - 10 von insgesamt 28
2023
| Schlagwörter | Text ; ddc:610 |
|---|---|
| Sprache | Englisch |
| Erscheinungsdatum | 2023-01-04 |
| Erscheinungsland | de |
| Dokumenttyp | Buch ; Audio / Video ; Online |
| Datenquelle | BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl) |
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2023
| Schlagwörter | Text ; ddc:610 |
|---|---|
| Sprache | Englisch |
| Erscheinungsdatum | 2023-01-04 |
| Erscheinungsland | de |
| Dokumenttyp | Buch ; Audio / Video ; Online |
| Datenquelle | BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl) |
Sie können sich den gewünschten Titel als lokale Nutzerin oder lokaler Nutzer von ZB MED direkt an den Standort Köln schicken lassen.
2024 Band 98, Heft 5, Seite(n) 1253–1269
Abstract: Since the 1940s, patch tests in healthy volunteers (Human Predictive Patch Tests, HPPTs) have been used to identify chemicals that cause skin sensitization in humans. Recently, we reported the results of a major curation effort to support the development ...
| Abstract | Since the 1940s, patch tests in healthy volunteers (Human Predictive Patch Tests, HPPTs) have been used to identify chemicals that cause skin sensitization in humans. Recently, we reported the results of a major curation effort to support the development of OECD Guideline 497 on Defined Approaches (DAs) for skin sensitization (OECD in Guideline No. 497: Defined Approaches on Skin Sensitisation, 2021a. https://doi.org/10.1787/b92879a4-en ). In the course of this work, we compiled and published a database of 2277 HPPT results for 1366 unique test substances (Strickland et al. in Arch Toxicol 97:2825-2837, 2023. https://doi.org/10.1007/s00204-023-03530-3 ). Here we report a detailed analysis of the value of HPPT data for classification of chemicals as skin sensitizers under the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). As a result, we propose the dose per skin area (DSA) used for classification by the GHS to be replaced by or complemented with a dose descriptor that may better reflect sensitization incidence [e.g., the DSA causing induction of sensitization in one individual (DSA1+) or the DSA leading to an incidence of induction in 5% of the tested individuals (DSA05)]. We also propose standardized concepts and workflows for assessing individual HPPT results, for integrating multiple HPPT results and for using them in concert with Local Lymph Node Assay (LLNA) data in a weight of evidence (WoE) assessment. Overall, our findings show that HPPT results are often not sufficient for deriving unambiguous classifications on their own. However, where they are, the resulting classifications are reliable and reproducible and can be integrated well with those from other skin sensitization data, such as the LLNA. |
|---|---|
| Mesh-Begriff(e) | Humans ; Patch Tests ; Dermatitis, Allergic Contact/etiology ; Allergens/toxicity ; Skin ; Local Lymph Node Assay |
| Chemische Substanzen | Allergens |
| Sprache | Englisch |
| Erscheinungsdatum | 2024-03-14 |
| Erscheinungsland | Germany |
| Dokumenttyp | Journal Article ; Review |
| ZDB-ID | 124992-7 |
| ISSN | 1432-0738 ; 0340-5761 |
| ISSN (online) | 1432-0738 |
| ISSN | 0340-5761 |
| DOI | 10.1007/s00204-023-03656-4 |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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2022 Band 96, Heft 8, Seite(n) 2387–2390
| Mesh-Begriff(e) | Risk Assessment |
|---|---|
| Sprache | Englisch |
| Erscheinungsdatum | 2022-06-10 |
| Erscheinungsland | Germany |
| Dokumenttyp | Letter ; Comment |
| ZDB-ID | 124992-7 |
| ISSN | 1432-0738 ; 0340-5761 |
| ISSN (online) | 1432-0738 |
| ISSN | 0340-5761 |
| DOI | 10.1007/s00204-022-03319-w |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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2023 Band 97, Heft 11, Seite(n) 2825–2837
Abstract: Critical to the evaluation of non-animal tests are reference data with which to assess their relevance. Animal data are typically used because they are generally standardized and available. However, when regulatory agencies aim to protect human health, ... ...
| Abstract | Critical to the evaluation of non-animal tests are reference data with which to assess their relevance. Animal data are typically used because they are generally standardized and available. However, when regulatory agencies aim to protect human health, human reference data provide the benefit of not having to account for possible interspecies variability. To support the evaluation of non-animal approaches for skin sensitization assessment, we collected data from 2277 human predictive patch tests (HPPTs), i.e., human repeat insult patch tests and human maximization tests, for skin sensitization from 1555 publications. We recorded protocol elements and positive or negative outcomes, developed a scoring system to evaluate each test for reliability, and calculated traditional and non-traditional dose metrics. We also traced each test result back to its original report to remove duplicates. The resulting database, which contains information for 1366 unique substances, was characterized for physicochemical properties, chemical structure categories, and protein binding mechanisms. This database is publicly available on the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods website and in the Integrated Chemical Environment to serve as a resource for additional evaluation of alternative methods and development of new approach methodologies for skin sensitization assessments. |
|---|---|
| Mesh-Begriff(e) | Humans ; Patch Tests ; Reproducibility of Results ; Skin ; Benchmarking ; Databases, Factual |
| Sprache | Englisch |
| Erscheinungsdatum | 2023-08-24 |
| Erscheinungsland | Germany |
| Dokumenttyp | Journal Article ; Review |
| ZDB-ID | 124992-7 |
| ISSN | 1432-0738 ; 0340-5761 |
| ISSN (online) | 1432-0738 |
| ISSN | 0340-5761 |
| DOI | 10.1007/s00204-023-03530-3 |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
| Uf I Zs.90: Hefte anzeigen | Standort: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG) |
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2003
| Verfasserangabe | von Matthias Herzler |
|---|---|
| Sprache | Deutsch |
| Umfang | Online-Ressource |
| Dokumenttyp | Buch ; Online ; Dissertation / Habilitation |
| Dissertation / Habilitation | Humboldt-Univ., Diss--Berlin, 2003 |
| Datenquelle | Ehemaliges Sondersammelgebiet Küsten- und Hochseefischerei |
Sie können sich den gewünschten Titel als lokale Nutzerin oder lokaler Nutzer von ZB MED direkt an den Standort Köln schicken lassen.
2021 Band 95, Heft 7, Seite(n) 2589–2601
| Mesh-Begriff(e) | European Union ; Risk Assessment ; Toxicology |
|---|---|
| Sprache | Englisch |
| Erscheinungsdatum | 2021-06-22 |
| Erscheinungsland | Germany |
| Dokumenttyp | Editorial |
| ZDB-ID | 124992-7 |
| ISSN | 1432-0738 ; 0340-5761 |
| ISSN (online) | 1432-0738 |
| ISSN | 0340-5761 |
| DOI | 10.1007/s00204-021-03091-3 |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
| Uf I Zs.90: Hefte anzeigen | Standort: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG) |
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2023 Band 40, Heft 4, Seite(n) 706–712
Abstract: Every test procedure, scientific and non-scientific, has inherent uncertainties, even when performed according to a standard operating procedure (SOP). In addition, it is prone to errors, defects, and mistakes introduced by operators, laboratory ... ...
| Abstract | Every test procedure, scientific and non-scientific, has inherent uncertainties, even when performed according to a standard operating procedure (SOP). In addition, it is prone to errors, defects, and mistakes introduced by operators, laboratory equipment, or materials used. Adherence to an SOP and comprehensive validation of the test method cannot guarantee that each test run produces data within the acceptable range of variability and with the precision and accuracy determined during the method validation. We illustrate here (part I) why controlling the validity of each test run is an important element of experimental design. The definition and application of acceptance criteria (AC) for the validity of test runs is important for the setup and use of test methods, particularly for the use of new approach methods (NAM) in toxicity testing. AC can be used for decision rules on how to handle data, e.g., to accept the data for further use (AC fulfilled) or to reject the data (AC not fulfilled). The adherence to AC has important requirements and consequences that may seem surprising at first sight: (i) AC depend on a test method's objectives, e.g., on the types/concentrations of chemicals tested, the regulatory context, the desired throughput; (ii) AC are applied and documented at each test run, while validation of a method (including the definition of AC) is only performed once; (iii) if AC are altered, then the set of data produced by a method can change. AC, if missing, are the blind spot of quality assurance: Test results may not be reliable and comparable. The establishment and uses of AC will be further detailed in part II of this series. |
|---|---|
| Mesh-Begriff(e) | Humans ; Toxicity Tests ; Research Design ; Biological Science Disciplines |
| Sprache | Englisch |
| Erscheinungsdatum | 2023-10-27 |
| Erscheinungsland | Germany |
| Dokumenttyp | Editorial |
| ZDB-ID | 165707-0 |
| ISSN | 1868-8551 ; 1018-4562 ; 0946-7785 |
| ISSN (online) | 1868-8551 |
| ISSN | 1018-4562 ; 0946-7785 |
| DOI | 10.14573/altex.2310021 |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
| Zs.B 2971: Hefte anzeigen | Standort: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG) |
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2023 Band 97, Heft 11, Seite(n) 3005–3017
Abstract: Exposure to multiple substances is a challenge for risk evaluation. Currently, there is an ongoing debate if generic "mixture assessment/allocation factors" (MAF) should be introduced to increase public health protection. Here, we explore concepts of ... ...
| Abstract | Exposure to multiple substances is a challenge for risk evaluation. Currently, there is an ongoing debate if generic "mixture assessment/allocation factors" (MAF) should be introduced to increase public health protection. Here, we explore concepts of mixture toxicity and the potential influence of mixture regulation concepts for human health protection. Based on this analysis, we provide recommendations for research and risk assessment. One of the concepts of mixture toxicity is additivity. Substances may act additively by affecting the same molecular mechanism within a common target cell, for example, dioxin-like substances. In a second concept, an "enhancer substance" may act by increasing the target site concentration and aggravating the adverse effect of a "driver substance". For both concepts, adequate risk management of individual substances can reliably prevent adverse effects to humans. Furthermore, we discuss the hypothesis that the large number of substances to which humans are exposed at very low and individually safe doses may interact to cause adverse effects. This commentary identifies knowledge gaps, such as the lack of a comprehensive overview of substances regulated under different silos, including food, environmentally and occupationally relevant substances, the absence of reliable human exposure data and the missing accessibility of ratios of current human exposure to threshold values, which are considered safe for individual substances. Moreover, a comprehensive overview of the molecular mechanisms and most susceptible target cells is required. We conclude that, currently, there is no scientific evidence supporting the need for a generic MAF. Rather, we recommend taking more specific measures, which focus on compounds with relatively small ratios between human exposure and doses, at which adverse effects can be expected. |
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| Mesh-Begriff(e) | Humans ; Drug-Related Side Effects and Adverse Reactions ; Food ; Polychlorinated Dibenzodioxins ; Public Health ; Risk Assessment |
| Chemische Substanzen | Polychlorinated Dibenzodioxins |
| Sprache | Englisch |
| Erscheinungsdatum | 2023-08-24 |
| Erscheinungsland | Germany |
| Dokumenttyp | Review ; Editorial |
| ZDB-ID | 124992-7 |
| ISSN | 1432-0738 ; 0340-5761 |
| ISSN (online) | 1432-0738 |
| ISSN | 0340-5761 |
| DOI | 10.1007/s00204-023-03565-6 |
| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
| Uf I Zs.90: Hefte anzeigen | Standort: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG) |
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Environment International. 2023 Aug., v. 178 p.108082-
2023
Abstract: The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, ... ...
| Abstract | The predominantly animal-centric approach of chemical safety assessment has increasingly come under pressure. Society is questioning overall performance, sustainability, continued relevance for human health risk assessment and ethics of this system, demanding a change of paradigm. At the same time, the scientific toolbox used for risk assessment is continuously enriched by the development of “New Approach Methodologies” (NAMs). While this term does not define the age or the state of readiness of the innovation, it covers a wide range of methods, including quantitative structure–activity relationship (QSAR) predictions, high-throughput screening (HTS) bioassays, omics applications, cell cultures, organoids, microphysiological systems (MPS), machine learning models and artificial intelligence (AI). In addition to promising faster and more efficient toxicity testing, NAMs have the potential to fundamentally transform today’s regulatory work by allowing more human-relevant decision-making in terms of both hazard and exposure assessment. Yet, several obstacles hamper a broader application of NAMs in current regulatory risk assessment. Constraints in addressing repeated-dose toxicity, with particular reference to the chronic toxicity, and hesitance from relevant stakeholders, are major challenges for the implementation of NAMs in a broader context. Moreover, issues regarding predictivity, reproducibility and quantification need to be addressed and regulatory and legislative frameworks need to be adapted to NAMs. The conceptual perspective presented here has its focus on hazard assessment and is grounded on the main findings and conclusions from a symposium and workshop held in Berlin in November 2021. It intends to provide further insights into how NAMs can be gradually integrated into chemical risk assessment aimed at protection of human health, until eventually the current paradigm is replaced by an animal-free “Next Generation Risk Assessment” (NGRA). |
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| Schlagwörter | artificial intelligence ; chemical risk assessment ; chemical safety ; chronic toxicity ; decision making ; environment ; ethics ; exposure assessment ; hazard characterization ; health effects assessments ; human health ; humans ; organoids ; quantitative structure-activity relationships ; safety assessment ; stakeholders ; AI ; AOPs ; APCRA ; BfR ; BMD ; CSS ; DA ; DART ; DB-ALM ; DIP ; DNT ; EAGMST ; ECHA ; ED ; EDSP ; EFSA ; EPAA ; EURL ECVAM ; FAIR ; GCCP ; GD ; GD-GIVMP ; HBGV ; HTS ; IATA ; ICCR ; ICCVAM ; IRS ; IVB DNT ; JRC ; KEs ; LOAEL ; MAD ; MIEs ; MOA ; MPS ; NGRA ; Ngtx carc ; NTA ; OECD ; OORF ; PARC ; PBK ; POD ; PTGS ; qAOP ; QIVIVE ; QSAR ; RMSE ; SIRs ; SSA ; STOTs ; TGs ; TSCA ; UN GHS ; US EPA ; WOE ; WPHA ; New approach methodologies ; Human health protection ; Regulatory risk assessment ; Next generation risk assessment ; Regulatory toxicology |
| Sprache | Englisch |
| Erscheinungsverlauf | 2023-08 |
| Erscheinungsort | Elsevier Ltd |
| Dokumenttyp | Artikel ; Online |
| ZDB-ID | 554791-x |
| ISSN | 1873-6750 ; 0160-4120 |
| ISSN (online) | 1873-6750 |
| ISSN | 0160-4120 |
| DOI | 10.1016/j.envint.2023.108082 |
| Datenquelle | NAL Katalog (AGRICOLA) |
| Zs.A 3131: Hefte anzeigen | Standort: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG) |
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