Inter‐laboratory control data for reproductive endpoints required in the OPPTS 870.3800/OECD 416 reproduction and fertility test

Marty, M. Sue; Allen, Bruce C.; Chapin, Robert E.; Cooper, Ralph L.; Daston, George P.; Flaws, Jodi A.; Foster, Paul M.D.; Makris, Susan L.; Mylchreest, Eve; Sandler, DP; Tyl, Rochelle W.

doi:10.1002/bdrb.20208

Cited by 22 publications

(19 citation statements)

References 30 publications

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“…Seminal vesicle weights can vary due to differing amounts of seminal fluid, which is influenced by numerous factors (Luke and Coffey, 1994). Inherent variability in prostate weights was recognized in a recent analysis of multigeneration study endpoints (Marty et al , 2009). …”

Section: Resultsmentioning

confidence: 99%

An F1-Extended One-Generation Reproductive Toxicity Study in Crl:CD(SD) Rats With 2,4-Dichlorophenoxyacetic Acid

Marty

Neal

Zablotny

et al. 2013

Toxicological Sciences

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2,4-Dichlorophenoxyacetic acid (2,4-D) was assessed for systemic toxicity, reproductive toxicity, developmental neurotoxicity (DNT), developmental immunotoxicity (DIT), and endocrine toxicity. CD rats (27/sex/dose) were exposed to 0, 100, 300, 600 (female), or 800 (male) ppm 2,4-D in diet. Nonlinear toxicokinetic behavior was shown at high doses; the renal clearance saturation threshold for 2,4-D was exceeded markedly in females and slightly exceeded in males. Exposure was 4 weeks premating, 7 weeks postmating for P1 males and through lactation for P1 females. F1 offspring were examined for survival and development, and at weaning, pups were divided in cohorts, by sex and dose, and by systemic toxicity (10), DNT (10), DIT (20), and reproductive toxicity (≥ 23). Remaining weanlings were evaluated for systemic toxicity and neuropathology (10–12). Body weight decreased during lactation in high-dose P1 females and in F1 pups. Kidney was the primary target organ, with slight degeneration of proximal convoluted tubules observed in high-dose P1 males and in high-dose F1 males and females. A slight intergenerational difference in kidney toxicity was attributed to increased intake of 2,4-D in F1 offspring. Decreased weanling testes weights and delayed preputial separation in F1 males were attributed to decreased body weights. Endocrine-related effects were limited to slight thyroid hormone changes and adaptive histopathology in high-dose GD 17 dams seen only at a nonlinear toxicokinetic dose. 2,4-D did not cause reproductive toxicity, DNT, or DIT. The “No Observed Adverse Effect Level” for systemic toxicity was 300 ppm in both males (16.6mg/kg/day) and females (20.6mg/kg/day), which is approximately 6700- to 93 000-fold higher than that reported for 2,4-D exposures in human biomonitoring studies.

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Section: Resultsmentioning

confidence: 99%

An F1-Extended One-Generation Reproductive Toxicity Study in Crl:CD(SD) Rats With 2,4-Dichlorophenoxyacetic Acid

Marty

Neal

Zablotny

et al. 2013

Toxicological Sciences

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“…A retrospective analysis of multi‐generation studies using rats has also been performed (Marty et al. ).…”

Section: Introductionmentioning

confidence: 99%

“…Only a few peer-reviewed studies are available for Wistar Hannover rats (Aoyama et al 2002;Liberati et al 2002;Takeuchi et al 2011). A retrospective analysis of multi-generation studies using rats has also been performed (Marty et al 2009).…”

Section: Introductionmentioning

confidence: 99%

Historical control data on developmental toxicity studies in rodents

Ema¹,

Endoh²,

Fukushima³

et al. 2014

Congenital Anomalies

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“…Thus, this effect was not attributed to 2,4-D treatment. Inherent variability in male accessory sex tissue weights may have contributed to the group differences [100].…”

Section: Eogrtsmentioning

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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Inter‐laboratory control data for reproductive endpoints required in the OPPTS 870.3800/OECD 416 reproduction and fertility test

Abstract: These inter-laboratory control data provide a means for laboratories to review their performance on reproductive toxicity measures, and provide perspective for interpreting their own control data and data from treated animals.

Cited by 22 publications

References 30 publications

An F1-Extended One-Generation Reproductive Toxicity Study in Crl:CD(SD) Rats With 2,4-Dichlorophenoxyacetic Acid

An F1-Extended One-Generation Reproductive Toxicity Study in Crl:CD(SD) Rats With 2,4-Dichlorophenoxyacetic Acid

Historical control data on developmental toxicity studies in rodents

A Developmental and Reproductive Toxicology Program for Chemical Registration

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