ArticleToxicology2017
The margin of internal exposure (MOIE) concept for dermal risk assessment based on oral toxicity data - A case study with caffeine.
Article in Toxicology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed, 33 citations in OpenAlex.
- Article
- Monitoring arsenic species concentration in rice-based processed products distributed in South Korean markets and related risk assessment.Food science and biotechnology · 2023Article
- Letter to the editor regarding recent publication titled "Developing an internal threshold of toxicological concern (iTTC)" by Arnot et al. (2022).Journal of exposure science & environmental epidemiology · 2023Article
- Practical application of the interim internal threshold of toxicological concern (iTTC): a case study based on clinical data.Archives of toxicology · 2023Article
- Assessment of the predictive capacity of a physiologically based kinetic model using a read-across approach.Computational toxicology (Amsterdam, Netherlands) · 2021Article
- Internal Threshold of Toxicological Concern (iTTC): Where We Are Today and What Is Possible in the Near Future.Frontiers in toxicology · 2020Article
- Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop.Regulatory toxicology and pharmacology : RTP · 2019Review
- Adverse Maternal, Fetal, and Postnatal Effects of Hexafluoropropylene Oxide Dimer Acid (GenX) from Oral Gestational Exposure in Sprague-Dawley Rats.Environmental health perspectives · 2019Article
- From in vitro to in vivo: Integration of the virtual cell based assay with physiologically based kinetic modelling.Toxicology in vitro : an international journal published in association with BIBRA · 2017Article
- Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.Regulatory toxicology and pharmacology : RTP · 2017Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Route-to-route extrapolation is a common part of human risk assessment. Data from oral animal toxicity studies are commonly used to assess the safety of various but specific human dermal exposure scenarios. Using theoretical examples of various user scenarios, it was concluded that delineation of a generally applicable human dermal limit value is not a practicable approach, due to the wide variety of possible human exposure scenarios, including its consequences for internal exposure. This paper uses physiologically based kinetic (PBK) modelling approaches to predict animal as well as human internal exposure dose metrics and for the first time, introduces the concept of Margin of Internal Exposure (MOIE) based on these internal dose metrics. Caffeine was chosen to illustrate this approach. It is a substance that is often found in cosmetics and for which oral repeated dose toxicity data were available. A rat PBK model was constructed in order to convert the oral NOAEL to rat internal exposure dose metrics, i.e. the area under the curve (AUC) and the maximum concentration (C
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.