The Use of Nanomaterial In Vivo Organ Burden Data for In Vitro Dose Setting

Ma‐Hock, Lan; Sauer, Ursula G.; Ruggiero, Emmanuel; Keller, Johannes-Georg; Wohlleben, Wendel; Landsiedel, Robert

doi:10.1002/smll.202005725

Cited by 14 publications

(22 citation statements)

References 53 publications

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“…There is a lack of OECD test guidelines specifically adopted for NMs. Dosing : Which concentrations should be tested? (see Keller et al, 2021; Ma‐Hock et al, 2021). What would be a meaningful top concentration?…”

Section: Discussionmentioning

confidence: 99%

Genotoxicity testing of nanomaterials

Landsiedel

Honarvar

Seiffert

et al. 2022

WIREs Nanomed Nanobiotechnol

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Nanomaterials have outstanding and unprecedented advantageous material properties but may also cause adverse effects in humans upon exposure. Testing nanomaterials for genotoxic properties is challenging because traditional testing methods were designed for small, soluble molecules and may not be easily applicable without modifications. This review critically examines available genotoxicity tests for use with nanomaterials, including DNA damage tests such as the comet assay, gene mutation tests such as the mouse lymphoma and hprt assay, and chromosome mutation tests such as the micronucleus test and the chromosome aberration test. It presents arguments for the relative usefulness of various tests, such as preferring the micronucleus test over the chromosome aberration test for scoring chromosome mutations and preferring mammalian cell gene mutation tests because the Ames test has limited utility. Finally, it points out the open questions and further needs in adapting genotoxicity tests for nanomaterials, such as validation, reference nanomaterials, and the selection of top test concentrations, as well as the relevance and applicability of test systems and the need to define testing strategies.This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Toxicology of Nanomaterials Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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Section: Discussionmentioning

confidence: 99%

Genotoxicity testing of nanomaterials

Landsiedel

Honarvar

Seiffert

et al. 2022

WIREs Nanomed Nanobiotechnol

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“…This question is regularly addressed through in vitro to in vivo extrapolation (IVIVE), utilising physiologically-based toxicokinetic (PBTK) modelling and in vitro dose characterisation. These concepts have been described, inter alia , by Rotroff et al, 17 Armitage et al, 18 Hubal et al 19 and Algharably et al 20 The concept of IVIVE has been applied to various substances, and its limitations have been discussed by, for example, Strikwold et al, 21 Fabian et al, 22 Honda et al, 23 Ma-Hock et al 24 and Chang et al 25 — How reliable are the data obtained from NAMs? (i.e.…”

Section: The ‘Species’: Toxicological Methods Including Animal Models...mentioning

confidence: 99%

The Evolution of Regulatory Toxicology: Where is the Gardener?

2022

Self Cite

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There is a need for paradigm change in the methodology employed for toxicological testing and assessment. It could be said that this change is well on its way, through an evolutionary progress analogous to that of natural selection. Darwin’s Theory of Evolution has defined the idea of evolution and descendancy since the last third of the 19th century. Increasingly, this concept of ‘evolution’ is being applied beyond the field of biology. This Comment article discusses the progress of toxicological testing in the context of ‘evolutionary pressure’ and deliberates how this process can help foster the development, implementation and acceptance of mechanistic and human-relevant methods in this field. By comparing the current regulatory landscape in toxicity testing and assessment to specific elements in Charles Darwin’s evolutionary theory, we aim to better understand the needs and requirements for the future.

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“…These measured or modeled concentrations during in vitro experiments can then be compared to modeled concentrations of the internal dose during the in vivo experiments such as by using the multi-path particle dosimetry model [ 207 , 208 ]. It is also possible to use lung burden measurements for IVIVE comparisons when historical data are available [ 209 ]. Performing lung burden measurements is an option in OECD standard methods (for example, TG 413 [ 210 ]) for particles that may be retained such as ENMs.…”

Section: Case Examples From the Literaturementioning

confidence: 99%

IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

Chang¹,

Tan

Allen³

et al. 2022

Toxics

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During the past few decades, the science of toxicology has been undergoing a transformation from observational to predictive science. New approach methodologies (NAMs), including in vitro assays, in silico models, read-across, and in vitro to in vivo extrapolation (IVIVE), are being developed to reduce, refine, or replace whole animal testing, encouraging the judicious use of time and resources. Some of these methods have advanced past the exploratory research stage and are beginning to gain acceptance for the risk assessment of chemicals. A review of the recent literature reveals a burst of IVIVE publications over the past decade. In this review, we propose operational definitions for IVIVE, present literature examples for several common toxicity endpoints, and highlight their implications in decision-making processes across various federal agencies, as well as international organizations, including those in the European Union (EU). The current challenges and future needs are also summarized for IVIVE. In addition to refining and reducing the number of animals in traditional toxicity testing protocols and being used for prioritizing chemical testing, the goal to use IVIVE to facilitate the replacement of animal models can be achieved through their continued evolution and development, including a strategic plan to qualify IVIVE methods for regulatory acceptance.

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The Use of Nanomaterial In Vivo Organ Burden Data for In Vitro Dose Setting

Cited by 14 publications

References 53 publications

Genotoxicity testing of nanomaterials

Genotoxicity testing of nanomaterials

The Evolution of Regulatory Toxicology: Where is the Gardener?

IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

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