Commentary on the Role of Maternal Toxicity on Developmental Toxicity

Tyl, Rochelle W.

doi:10.1002/bdrb.21015

Cited by 9 publications

(3 citation statements)

References 17 publications

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“…Nitrite can retard the development of the central nervous system, particularly dendritic development and may cause mental retardation (Chen, et al, 2016). Mammalian maternal toxicity disrupt prenatal development, with general systemic maternal toxicity, including decreased weight gain to morbidity, causative for decreased fetal weights/litter and increased skeletal fetal variations/litter, but not, in the author's opinion, for increased fetal malformations, decreased litter sizes or full litter losses (Tyl, 2012). Although sodium nitrite (NaNO2) is frequently used as a food additive, its extensive intake has toxic effects on females fertility and fetal development but its mechanism remains unknown (Ge et al, 2019).…”

Section: Maternal Toxicitymentioning

confidence: 97%

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Reproductive Toxicity of Sodium Nitrite and Its Modulation by Ascorbic Acid as An Antioxidant in Pregnant Female Mice

Kotb,

Abdellateif²,

Zaghloul³

et al. 2023

Egyptian Academic Journal of Biological Sciences, B. Zoology

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Sodium nitrite (NaNO 2 ) is a water-soluble compound, wellknown as a principal food preservative and colorant in the food industry. Besides the variety of industrial and medicinal applications, toxicity to humans and animals is well documented after nitrite overexposure. The present work was carried out to investigate the maternal and developmental toxicity of sodium nitrite and its modulation by ascorbic acid as an antioxidant in pregnant female mice. Forty-eight pregnant female mice were divided into equal sex groups (8 per group). Group I was used as control. Group II received 100 mg/kg of ascorbic acid. Groups III& IV received 0.016 and 0.032 mg sodium nitrite/g body weight. Group V and VI received 0.016 and 0.032 mg sodium nitrite /g body with 100 mg ascorbic acid/kg body weight. Pregnant female mice were orally administered doses at days from 8 to 17 of gestation and sacrificed on day 18 of gestation. Sodium nitrite treatment during late pregnancy induced maternal toxicity as indicated by a reduction in the maternal body weight and incidence of both partial and complete resorption of implants and miscarriage of fetuses. Examination of life fetuses from NaNO2-treated dams showed fetal growth retardation and a significant increase in the percentage of malformed fetuses per dam and the % of dams with malformed fetuses. These malformations were clearly recorded in both gross morphology and skeleton of the fetuses (sternebrae). The assessment of skeletal ossification of life fetuses showed marked retardation in the major parts of the skeleton. The results could be concluded that ascorbic acid administration may ameliorate the maternal toxic effects of NaNO2.

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Section: Maternal Toxicitymentioning

confidence: 97%

“…Information to inform maternal and developmental toxicities includes uterine implantation profile, degree of litter reduction, ovarian corpora lutea counts, extent and timing of maternal toxicity relative to those of opposing fetalembryo effects, etc. (Tyl, 2012).…”

Section: Malformationsmentioning

confidence: 99%

Reproductive Toxicity of Sodium Nitrite and Its Modulation by Ascorbic Acid as An Antioxidant in Pregnant Female Mice

Kotb,

Abdellateif²,

Zaghloul³

et al. 2023

Egyptian Academic Journal of Biological Sciences, B. Zoology

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“…Fetal skeletal variations typically observed are delays in bone ossification and are often associated with delay in maternal body weight gain [51,52]. These effects combined represent a generalized delay in fetal maturation (i.e., developmental delay).…”

Section: Developmental Toxicity Definitive Study (Oecd 414)mentioning

confidence: 99%

A Developmental and Reproductive Toxicology Program for Chemical Registration

Johnson

Hannas

Marty

et al. 2016

Methods in Pharmacology and Toxicology

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The goal of the chapter is to outline the process of testing molecules for potential developmental and reproductive toxicity (DART). Here, the entire process of DART testing is discussed, from the regulatory use of DART data to the conduct and interpretation of the various DART study designs. Although nonanimal DART testing strategies are envisioned by the new science of "21st Century Toxicity Testing", these high-content, high-throughput testing paradigms are not sufficiently mature from a scientific perspective to be acceptable on their own by regulatory agencies for chemical registration. Thus, these testing paradigms are not included in this chapter. While the scope of the chapter is broad, it is beyond the range of this chapter to describe all possible scenarios encountered in DART testing. For additional information, the reader is referred to other recent publications on this topic. The chapter is organized in a stepwise manner into three main topics: (1) Use of DART studies for chemical registration; (2) General considerations for all DART study designs; and (3) Descriptions of all DART study designs from a practical perspective, beginning with an initial range-finding study and ending with the complex Extended One-Generation Reproductive Toxicity Study (EOGRTS).

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Bone development in laboratory mammals used in developmental toxicity studies

DeSesso

2018

Birth Defects Research

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Evaluation of the skeleton in laboratory animals is a standard component of developmental toxicology testing. Standard methods of performing the evaluation have been established, and modification of the evaluation using imaging technologies is under development. The embryology of the rodent, rabbit, and primate skeleton has been characterized in detail and summarized herein. The rich literature on variations and malformations in skeletal development that can occur in the offspring of normal animals and animals exposed to test articles in toxicology studies is reviewed. These perturbations of skeletal development include ossification delays, alterations in number, shape, and size of ossification centers, and alterations in numbers of ribs and vertebrae. Because the skeleton is undergoing developmental changes at the time fetuses are evaluated in most study designs, transient delays in development can produce apparent findings of abnormal skeletal structure. The determination of whether a finding represents a permanent change in embryo development with adverse consequences for the organism is important in study interpretation. Knowledge of embryological processes and schedules can assist in interpretation of skeletal findings. K E Y W O R D Sembryology, developmental toxicity testing, embryofetal toxicology testing, ossification, skeletal development, supernumerary ribs, wavy ribs | DEFINITION OF THE PROBLEMDevelopmental toxicity testing includes assessment of the near-term fetal skeleton in laboratory animals, particularly rats, mice, and rabbits. Alterations associated with treatment usually are categorized as malformations or variations, defined in section 2, below. The distinction between variations and malformations is not always clear, and different laboratories may produce different assessments. The biological importance of variations may also be unclear. We will review the published data on these skeletal findings with emphasis on the biological significance of the skeletal changes that have been the most variably interpreted.We are not the first authors to undertake an assessment of developmental changes in the skeleton. Among the helpful reviews in the literature are those by Kimmel and Wilson (1973), Chernoff and Rogers (2004), Tyl, Chernoff, and Rogers (2007), Daston and Seed (2007), Carney and Kimmel (2007), Beyer et al. (2011), Kimmel, Garry, andDeSesso (2014), and Hofmann, Buesen, Schneider, and van Ravenzwaay (2016). | REGULATORY REQUIREMENTS | TechniquesMost pharmaceutical and many non-pharmaceutical chemicals are evaluated for developmental toxicity in experimental animals prior to marketing approval. The requirements for pharmaceutical chemicals have been harmonized for use in Europe, the US, and Japan (ICH, 2005(ICH, , 2017 wileyonlinelibrary.com/journal/bdr2 1157 examination of preferably all fetuses is part of the developmental toxicity evaluation; however, the method of skeletal examination is not specified. The newer techniques of microcomputerized tomography and magnetic resonance imaging ...

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Commentary on the Role of Maternal Toxicity on Developmental Toxicity

Cited by 9 publications

References 17 publications

Reproductive Toxicity of Sodium Nitrite and Its Modulation by Ascorbic Acid as An Antioxidant in Pregnant Female Mice

Reproductive Toxicity of Sodium Nitrite and Its Modulation by Ascorbic Acid as An Antioxidant in Pregnant Female Mice

A Developmental and Reproductive Toxicology Program for Chemical Registration

Bone development in laboratory mammals used in developmental toxicity studies

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