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Article ; Online: The era of 3Rs implementation in developmental and reproductive toxicity (DART) testing: Current overview and future perspectives.

Beekhuijzen, Manon

Reproductive toxicology (Elmsford, N.Y.)

2017 Volume 72, Page(s) 86–96

Abstract: Since adoption of the first globally implemented guidelines for developmental and reproductive toxicity (DART) testing for pharmaceuticals, industrial chemicals and agrochemicals, many years passed without major updates. However in recent years, ... ...

Abstract	Since adoption of the first globally implemented guidelines for developmental and reproductive toxicity (DART) testing for pharmaceuticals, industrial chemicals and agrochemicals, many years passed without major updates. However in recent years, significant changes in these guidelines have been made or are being implemented. These changes have been guided by the ethical drive to reduce, refine and replace (3R) animal testing, as well as the addition of endocrine disruptor relevant endpoints. Recent applied improvements have focused on reduction and refinement. Ongoing scientific and technical innovations will provide the means for replacement of animal testing in the future and will improve predictivity in humans. The aim of this review is to provide an overview of ongoing global DART endeavors in respect to the 3Rs, with an outlook towards future advances in DART testing aspiring to reduce animal testing to a minimum and the supreme ambition towards animal-free hazard and risk assessment.
Language	English
Publishing date	2017-09
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2017.05.006
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Article ; Online ; Conference proceedings: 11th ETS Special Issue of Reproductive Toxicology: Welcome!

Beekhuijzen, Manon

Reproductive toxicology (Elmsford, N.Y.)

2015 Volume 56, Page(s) xxi

MeSH term(s)	Animals ; Humans ; Reproduction/drug effects ; Risk Assessment ; Toxicology/methods
Language	English
Publishing date	2015-08-15
Publishing country	United States
Document type	Congresses ; Editorial ; Introductory Journal Article
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/S0890-6238(15)00257-9
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Article ; Online: Is there a rationale for direct dosing of chemicals to nursing pups in the EOGRTS (OECD 443)?

Arts, Josje / Beekhuijzen, Manon

Regulatory toxicology and pharmacology : RTP

2020 Volume 113, Page(s) 104641

Abstract: In OECD guideline 443 - Extended One Generation Reproductive Toxicity Study (EOGRTS) - to be used for testing industrial and agrochemicals, it has been indicated that careful consideration of benefits and disadvantages should be made prior to conducting ... ...

Abstract	In OECD guideline 443 - Extended One Generation Reproductive Toxicity Study (EOGRTS) - to be used for testing industrial and agrochemicals, it has been indicated that careful consideration of benefits and disadvantages should be made prior to conducting direct-dosing studies in nursing pups. Nursing pups will not be directly dosed in dietary and drinking water studies whereas in oral gavage studies this possibility exists. Besides the risk of intubation trauma and overdosing due to direct exposure and exposure via the mother's milk, direct dosing could lead to a different hazard assessment of chemicals depending on the choice of the route of administration. In addition, in case of industrial and agrochemicals used in industrial or professional settings only, there will never be direct exposure of newborns. Moreover, direct dosing of nursing pups is an artificial, non-physiological, route of exposure and as such it would hamper risk assessment. It should therefore only be considered in exceptional cases and justified on a case-by-case approach.
MeSH term(s)	Agrochemicals/adverse effects ; Agrochemicals/standards ; Agrochemicals/toxicity ; Animals ; Animals, Newborn ; Dose-Response Relationship, Drug ; Humans ; Infant, Newborn ; Organisation for Economic Co-Operation and Development/standards ; Risk Assessment ; Toxicity Tests/standards
Chemical Substances	Agrochemicals
Language	English
Publishing date	2020-03-09
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2020.104641
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Article ; Online: Unnecessary use of additional animals for determination of sexual maturation in the EOGRTS.

Oldenburger, Marcia M / Doomen, Mabel J / Lourens, Nicky J J / Beekhuijzen, Manon

Reproductive toxicology (Elmsford, N.Y.)

2022 Volume 112, Page(s) 14–22

Abstract: The Extended-One-Generation Study [EOGRTS, OECD 443] is a study in which the toxic effects of test substances on reproduction (Cohort 1), neurodevelopment (Cohort 2), and development of the immune system (Cohort 3) in rats are evaluated. The latter two ... ...

Abstract	The Extended-One-Generation Study [EOGRTS, OECD 443] is a study in which the toxic effects of test substances on reproduction (Cohort 1), neurodevelopment (Cohort 2), and development of the immune system (Cohort 3) in rats are evaluated. The latter two Cohorts are not always required according to the European Chemicals Agency (ECHA) based on data from previously performed toxicity studies. Although the Cohorts for developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT) are often omitted, the F
MeSH term(s)	Animals ; Cohort Studies ; Female ; Humans ; Immune System ; Male ; Rats ; Reproduction ; Sexual Maturation ; Toxicity Tests/methods
Language	English
Publishing date	2022-06-15
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2022.06.006
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Article ; Online: An overview of the current challenges when using rabbits for prenatal developmental toxicity studies with consideration of the impact on data interpretation.

Moxon, Mary / Beekhuijzen, Manon / Hannas, Bethany / Manton, Jason / French, Julian / Malley, Linda

Reproductive toxicology (Elmsford, N.Y.)

2023 Volume 118, Page(s) 108386

Abstract: The rabbit prenatal developmental toxicity study is an international testing requirement for the identification and characterisation of the potential hazards of chemicals to human health. The importance of the rabbit for the detection of chemical ... ...

Abstract	The rabbit prenatal developmental toxicity study is an international testing requirement for the identification and characterisation of the potential hazards of chemicals to human health. The importance of the rabbit for the detection of chemical teratogens is without question. However, the rabbit when used as a laboratory test species presents unique challenges affecting data interpretation. The purpose of this review is to identify the factors which may impact the behaviour of the pregnant rabbit and lead to significant inter-animal variability, confounding interpretation of maternal toxicity. Additionally, the importance of appropriate dose selection is discussed not least because of the conflicting guidance for identifying and defining acceptable maternal toxicity that lack reference to the rabbit in particular. The test guideline prenatal developmental toxicity study is often unable to distinguish between developmental effects as a consequence of maternal toxicity and those that are a direct effect of the test chemical on the offspring yet there is increasing pressure to use the highest possible dose levels to induce significant maternal toxicity which for the rabbit, a species little understood in toxicological terms and one that is highly susceptible to stress, is defined by very few endpoints. Interpretation of study data is further confounded by dose selection yet the developmental effects, even in the presence of maternal toxicity, are being used in Europe as the basis for classifying agents as reproductive hazards and the maternal effects are being used to define key reference values.
MeSH term(s)	Pregnancy ; Animals ; Female ; Rabbits ; Humans ; Teratogens/toxicity ; Growth and Development ; Europe
Chemical Substances	Teratogens
Language	English
Publishing date	2023-04-25
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2023.108386
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Article ; Online: Is omphalocele a non-specific malformation in New Zealand White rabbits?

Daston, George P / Beekhuijzen, Manon

Reproductive toxicology (Elmsford, N.Y.)

2018 Volume 78, Page(s) 29–39

Abstract: We evaluated the incidence of omphalocele, a malformation that occurs sporadically in many studies. We assembled data on external malformations using all treatment groups from every study published in three major journals over the past 35 years using New ...

Abstract	We evaluated the incidence of omphalocele, a malformation that occurs sporadically in many studies. We assembled data on external malformations using all treatment groups from every study published in three major journals over the past 35 years using New Zealand White rabbits. Fifty-eight papers were included: 4905 litters and 36,977 fetuses. Omphalocele was reported in 43% and was among the most common defects, occurring at a rate of 1.10% (litter) and 0.16% (fetus). The defect did not appear to be treatment-related, although it may have been in two studies, based on rate and dose-responsiveness. Removing these two studies from the analysis, the defect was still prevalent (0.77% litter, 0.11% fetal incidence). Three studies evaluated the effects of food restriction and omphalocele was observed with food restriction in two of them, suggesting that decreased maternal weight gain or food consumption may be causal. Otherwise, it appears to be spontaneous and common.
MeSH term(s)	Animals ; Congenital Abnormalities/etiology ; Congenital Abnormalities/veterinary ; Eating ; Female ; Hernia, Umbilical/etiology ; Hernia, Umbilical/veterinary ; Pregnancy ; Rabbits ; Toxicity Tests ; Weight Gain
Language	English
Publishing date	2018-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2018.03.006
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Article ; Online: A Critical Assessment of the Requirement for a Single Time Point Vaginal Cytology on the Day of Necropsy in Rats.

de Rijk, Eveline / Beekhuijzen, Manon / Lambregts, Ankie / Czajkowski, Melissa / van den Brink-Knol, Hetty

Toxicologic pathology

2022 Volume 50, Issue 4, Page(s) 466–477

Abstract: For toxicology testing of (agro)chemicals, different study types are being performed with general and/or reproductive toxicity endpoints (see Organisation for Economic Co-operation and Development guidelines). In most of these rat studies, vaginal ... ...

Abstract	For toxicology testing of (agro)chemicals, different study types are being performed with general and/or reproductive toxicity endpoints (see Organisation for Economic Co-operation and Development guidelines). In most of these rat studies, vaginal cytology is performed on serial samples (collected by lavage) for evaluation of cycle regularity and evidence of mating, and/or on a single sample collected on the day of necropsy for information on the estrous cycle stage and allowing correlation with histopathology. In the latter case, the utility of vaginal cytology can be argued. In this article, estrous cycle stages based on vaginal cytology of samples taken on the day of necropsy and histopathology of ovaries, uterus, and vagina (gold standard for estrous cycle stage assessment) were compared. The agreement was generally low. Disagreement between the two methods could be explained by time differences between lavage and necropsy, by manipulation of vaginal epithelium during lavage which may impact epithelial morphology on histology, and by misinterpretation of vaginal cytology during or shortly after lactation. Based on the results of estrous staging within different study types, we strongly discourage vaginal cytology from samples collected on the day of necropsy since there is no added value, vaginal manipulation can be stressful and may complicate the histologic diagnosis.
MeSH term(s)	Animals ; Epithelium ; Estrous Cycle ; Estrus ; Female ; Ovary ; Rats ; Uterus ; Vagina
Language	English
Publishing date	2022-06-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/01926233221103273
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Zs.A 1975: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: A critical evaluation of thyroid hormone measurements in OECD test guideline studies: Is there any added value?

Beekhuijzen, Manon / Rijk, Jeroen C W / Meijer, Marieke / de Raaf, Michiel Alexander / Pelgrom, Sylvia

Reproductive toxicology (Elmsford, N.Y.)

2019 Volume 88, Page(s) 56–66

Abstract: Recently several OECD test guidelines were updated to include thyroid hormone measurements for assessing endocrine disruptor potency, which led to an imperative need to align interpretation of these results by the different stakeholders. We therefore ... ...

Abstract	Recently several OECD test guidelines were updated to include thyroid hormone measurements for assessing endocrine disruptor potency, which led to an imperative need to align interpretation of these results by the different stakeholders. We therefore evaluated 124 repro screening studies, which showed in 38% of the studies a statistical significant finding for T4 in at least one treatment group, probably due to disturbances of normal homeostasis causing high variation. Consequently, for a thorough evaluation it is extremely important to take the historical control range into account. In conclusion, the current testing approach is not providing specific information needed to assess endocrine disruption, as too often a statistical significant finding is noted and as down-stream adverse effects are not evaluated. Therefore, major modifications are urgently needed. Instead of extending the in vivo experiments, it should be investigated if in vitro assessments will provide more relevant information on human endocrine disruptor potential.
MeSH term(s)	Animals ; Endocrine Disruptors/toxicity ; European Union ; Female ; Guidelines as Topic/standards ; Humans ; Male ; Organisation for Economic Co-Operation and Development/standards ; Rats ; Thyroid Gland/drug effects ; Thyroid Hormones/blood ; Thyrotropin/blood ; Thyroxine/blood ; Toxicology/methods ; Toxicology/standards ; Triiodothyronine/blood ; United States
Chemical Substances	Endocrine Disruptors ; Thyroid Hormones ; Triiodothyronine (06LU7C9H1V) ; Thyrotropin (9002-71-5) ; Thyroxine (Q51BO43MG4)
Language	English
Publishing date	2019-07-23
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	639342-1
ISSN	1873-1708 ; 0890-6238
ISSN (online)	1873-1708
ISSN	0890-6238
DOI	10.1016/j.reprotox.2019.07.014
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Article ; Online: Effects of Capillary Microsampling on Toxicological Endpoints in Juvenile Rats.

Niu, Xiaoyu / Beekhuijzen, Manon / Schoonen, Willem / Emmen, Harry / Wenker, Mira

Toxicological sciences : an official journal of the Society of Toxicology

2016 Volume 154, Issue 1, Page(s) 69–77

Abstract: Blood sampling during juvenile rat toxicology studies is required to determine the toxicokinetic (TK) profile of compounds. Juvenile rats are too small to undergo repeated blood sampling using conventional methods, which collect 200-300 μl blood at each ... ...

Abstract	Blood sampling during juvenile rat toxicology studies is required to determine the toxicokinetic (TK) profile of compounds. Juvenile rats are too small to undergo repeated blood sampling using conventional methods, which collect 200-300 μl blood at each time point. Recently, capillary microsampling (CMS) gained interest because sample sizes are almost 10 times smaller enabling multi-sample collection from 1 rat. Here, we evaluated the use of CMS in juvenile rats in support of reduced animal usage. Juvenile rats at postnatal day (PND) 4, 10, and 17 underwent CMS via the submandibular, tail, and jugular veins. The CMS methods for pups at different ages were evaluated based on sample quality and technical practicality as well as on acute and chronic changes of toxicological parameters. The best location for CMS was the submandibular vein for PND 4 and 10 pups and the tail vein for PND 17 pups. No effects were found on clinical signs, body and organ weights and biochemistry parameters when 2 × 32 μl of blood was withdrawn from PND 4 pups or when 3 × 32 μl was taken from PND 10 and 17 pups within 24 h. Significant changes in several hematology parameters were observed 24 h after CMS due to a decrease of red blood cells and renewed production. These values had recovered to normal 7 days after CMS. CMS is feasible in juvenile rats for TK assessment. Utilizing this method could decrease the number of additional animals by 75%.
Language	English
Publishing date	2016-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfw146
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Article ; Online: Towards a science-based testing strategy to identify maternal thyroid hormone imbalance and neurodevelopmental effects in the progeny - part II: how can key events of relevant adverse outcome pathways be addressed in toxicological assessments?

Marty, Sue / Beekhuijzen, Manon / Charlton, Alex / Hallmark, Nina / Hannas, Bethany R / Jacobi, Sylvia / Melching-Kollmuss, Stephanie / Sauer, Ursula G / Sheets, Larry P / Strauss, Volker / Urbisch, Daniel / Botham, Philip A / van Ravenzwaay, Bennard

Critical reviews in toxicology

2021 Volume 51, Issue 4, Page(s) 328–358

Abstract: The current understanding of thyroid-related adverse outcome pathways (AOPs) with adverse neurodevelopmental outcomes in mammals has been reviewed. This served to establish if standard rodent toxicity test methods ... ...

Abstract	The current understanding of thyroid-related adverse outcome pathways (AOPs) with adverse neurodevelopmental outcomes in mammals has been reviewed. This served to establish if standard rodent toxicity test methods and
MeSH term(s)	Adverse Outcome Pathways ; Animals ; Endocrine Disruptors ; Humans ; Nervous System/drug effects ; Nervous System/growth & development ; Neurotoxicity Syndromes ; Risk Assessment ; Thyroid Gland ; Thyroid Hormones ; Toxicity Tests/methods
Chemical Substances	Endocrine Disruptors ; Thyroid Hormones
Language	English
Publishing date	2021-06-02
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1097071-x
ISSN	1547-6898 ; 1040-8444
ISSN (online)	1547-6898
ISSN	1040-8444
DOI	10.1080/10408444.2021.1910625
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