[HTML][HTML] Distinguishing between endocrine disruption and non-specific effects on endocrine systems

MS Marty, C Borgert, K Coady, R Green… - Regulatory Toxicology …, 2018 - Elsevier
The endocrine system is responsible for growth, development, maintaining homeostasis and
for the control of many physiological processes. Due to the integral nature of its signaling …

Bone development in laboratory mammals used in developmental toxicity studies

JM DeSesso, AR Scialli - Birth defects research, 2018 - Wiley Online Library
Evaluation of the skeleton in laboratory animals is a standard component of developmental
toxicology testing. Standard methods of performing the evaluation have been established …

Use of category approaches, read-across and (Q) SAR: general considerations

G Patlewicz, N Ball, ED Booth, E Hulzebos… - Regulatory Toxicology …, 2013 - Elsevier
Read-across has generated much attention since it may be used as an alternative approach
for addressing the information requirements under regulatory programmes, notably the EU's …

Rethinking developmental toxicity testing: Evolution or revolution?

AR Scialli, G Daston, C Chen, PS Coder… - Birth defects …, 2018 - Wiley Online Library
Background Current developmental toxicity testing adheres largely to protocols suggested in
1966 involving the administration of test compound to pregnant laboratory animals. After …

[HTML][HTML] Finding synergies for 3Rs–Toxicokinetics and read-across: Report from an EPAA partners' Forum

C Laroche, M Aggarwal, H Bender, P Benndorf… - Regulatory Toxicology …, 2018 - Elsevier
Abstract The European Partnership for Alternative Approaches to Animal Testing (EPAA)
convened a Partners' Forum Toxicokinetics and Read-Across to provide an overview on …

[HTML][HTML] Opportunities and challenges related to saturation of toxicokinetic processes: implications for risk assessment

YM Tan, HA Barton, A Boobis, R Brunner… - Regulatory Toxicology …, 2021 - Elsevier
Top dose selection for repeated dose animal studies has generally focused on identification
of apical endpoints, use of the limit dose, or determination of a maximum tolerated dose …

[HTML][HTML] The current status of exposure-driven approaches for chemical safety assessment: A cross-sector perspective

F Sewell, M Aggarwal, G Bachler, A Broadmeadow… - Toxicology, 2017 - Elsevier
For the purposes of chemical safety assessment, the value of using non-animal (in silico and
in vitro) approaches and generating mechanistic information on toxic effects is being …

“The dose makes the poison”: key implications for mode of action (mechanistic) research in a 21st century toxicology paradigm

JS Bus - Current Opinion in Toxicology, 2017 - Elsevier
The concept of “the dose makes the poison” is a core organizing tenet of toxicology, and
associated investigations of mode of action (MoA) are a key means by which toxicity test …

[HTML][HTML] Predicting nonlinear relationships between external and internal concentrations with physiologically based pharmacokinetic modeling

D Hoer, HA Barton, A Paini, M Bartels, B Ingle… - Toxicology and applied …, 2022 - Elsevier
Although external concentrations are more readily quantified and often used as the metric
for regulating and mitigating exposures to environmental chemicals, the toxicological …

[HTML][HTML] Use of the kinetically-derived maximum dose concept in selection of top doses for toxicity studies hampers proper hazard assessment and risk management

MB Heringa, NHP Cnubben, W Slob, MEJ Pronk… - Regulatory Toxicology …, 2020 - Elsevier
The KMD (kinetically-derived maximum dose) is an increasingly advocated concept that
uses toxicokinetic data in the top dose selection for toxicity testing. Application of this …