Embryo/fetal development studies with hydroxypropyl methylcellulose acetate succinate (HPMCAS) in rats and rabbits

Cappon, Gregg D.; Fleeman, T.L.; Rocca, Meredith S.; Cook, Jon C.; Hurtt, Mark E.

doi:10.1002/bdrb.10039

Cited by 7 publications

(6 citation statements)

References 20 publications

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“…Based on the scores, the low‐ and mid‐dose groups are comparable to the control group, and the high‐dose has ninefold more teratogenic severity than the control. An interesting point to note is the low score for this control group of SD rats (i.e., 5) compared to the above‐mentioned control/vehicle studies (mean score of 11 and 27 in Cappon et al., and Enright et al., , respectively). Again these differences in control group values are likely attributed to different conducting laboratories.…”

Section: Resultsmentioning

confidence: 76%

“…The studies of Cappon et al. () and Enright et al. () provide vehicle‐treated groups of SD and New Zealand White (NZW) animals for calculation of teratogenic severity scores.…”

Section: Resultsmentioning

confidence: 99%

“…The studies of Cappon et al (2003b) and Enright et al (2010) provide vehicle-treated groups of SD and New Zealand White (NZW) animals for calculation of teratogenic severity scores. The studies with SD rats by these two laboratories produced somewhat different scores (means of groups evaluated: 11 and 27, respectively).…”

Section: Sampling Of Control and Vehicle-treated Groupsmentioning

confidence: 99%

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Numeric Estimates of Teratogenic Severity from Embryo–Fetal Developmental Toxicity Studies

Wise¹

2016

Birth Defects Research Pt B

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A developing organism exposed to a toxicant will have a response that ranges from none to severe (i.e., death or malformation). The response at a given dosage may be termed teratogenic (or developmental toxic) severity and is dependent on exposure conditions. Prenatal/embryo-fetal developmental (EFD) toxicity studies in rodents and rabbits are the most consistent and definitive assessments of teratogenic severity, and teratogenesis screening assays are best validated against their results. A formula is presented that estimates teratogenic severity for each group, including control, within an EFD study. The developmental components include embryonic/fetal death, malformations, variations, and mean fetal weight. The contribution of maternal toxicity is included with multiplication factors to adjust for the extent of mortality, maternal body weight change, and other parameters deemed important. The derivation of the formula to calculate teratogenic severity is described. Various EFD data sets from the literature are presented to highlight considerations to the calculation of the various components of the formula. Each score is compared to the concurrent control group to obtain a relative teratogenic severity. The limited studies presented suggest relative scores of two-to

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Section: Resultsmentioning

confidence: 76%

“…The studies of Cappon et al. () and Enright et al. () provide vehicle‐treated groups of SD and New Zealand White (NZW) animals for calculation of teratogenic severity scores.…”

Section: Resultsmentioning

confidence: 99%

Section: Sampling Of Control and Vehicle-treated Groupsmentioning

confidence: 99%

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Numeric Estimates of Teratogenic Severity from Embryo–Fetal Developmental Toxicity Studies

Wise¹

2016

Birth Defects Research Pt B

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“…Assessment of fetal specimens has historically been plagued by regional and interlaboratory differences in terminology and criteria for recording findings that deviate sufficiently from normal (Black & Marks, 1986; Schardein, 1988) that can result in incorrect interpretation, unnecessary replication of studies, and difficulty in comparing results across laboratories (Cappon et al, 2003; Christian, 1993). Multiple international efforts toward establishing harmonized terminology resulted in the 2009 publication Terminology of Developmental Abnormalities in Common Laboratory Animals ( Version 2 ) (Makris et al, 2009) which is generally considered the gold‐standard reference for terminology of fetal morphology.…”

Section: Introductionmentioning

confidence: 99%

Harmonization of criteria and terminology in fetal rat skeletal evaluations

Posobiec,

Kopp,

Murzyn

et al. 2023

Birth Defects Research

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Background: A survey of laboratories in North American and Europe that routinely conduct fetal skeletal examinations was performed with the purpose of (1) understanding current terminology used for classifying skeletal findings in developmental toxicity (DT) studies and (2) understanding the criteria used to identify relatively common findings that sufficiently deviate from normal.The goal was to promote terminology harmonization and improve interlaboratory consistency in the criteria used to identify developmental anomalies. Methods: The survey, designed based on terminology for developmental anomalies recommended by an international collaboration (Makris et al., Congenital Anomalies, 2009;49(3):123-246), was conducted by a subgroup (authors of this publication) of the Royal Society of Biology's International Register of Fetal Morphologists (IRFM). Results: Individual and summarized anonymized responses are provided here. The authors, who are expert fetal morphologists with experience performing fetal examinations, reviewed the responses and generated recommendations on preferred terminology and criteria for determining when morphological variations deviate from normal and warrant recording of the findings for skeletal observations in Sprague Dawley (SD) fetal rats. The objective of these recommendations is to complement Makris et al. (Congenital Anomalies, 2009;49 (3):123-246). Conclusion:The broad application will improve interlaboratory harmonization of recording fetal skeleton findings in developmental toxicity studies intended for regulatory submissions, including SEND (Standard for Exchange of Nonclinical Data).

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“…Oral gavage studies with Hydroxypropyl Methylcellulose acetate succinate in rats and rabbits at doses up to 2,500 mg/kg/day indicated no treatment‐related effects on fertility or embryo–fetal development (Hoshi et al, 1985a, b; Cappon et al, 2003). Similarly, oral gavage studies with PS 80 in rats at doses up to 5,000 mg/kg indicated no effects on embryo–fetal development (NTP, 1992).…”

Section: Introductionmentioning

confidence: 99%

Assessment of Hydroxypropyl Methylcellulose, Propylene Glycol, Polysorbate 80, and Hydroxypropyl‐β‐Cyclodextrin for use in developmental and reproductive toxicology studies

Enright

McIntyre

Thackaberry

et al. 2010

Birth Defects Research Pt B

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Embryo/fetal development studies with hydroxypropyl methylcellulose acetate succinate (HPMCAS) in rats and rabbits

Cited by 7 publications

References 20 publications

Numeric Estimates of Teratogenic Severity from Embryo–Fetal Developmental Toxicity Studies

Numeric Estimates of Teratogenic Severity from Embryo–Fetal Developmental Toxicity Studies

Harmonization of criteria and terminology in fetal rat skeletal evaluations

Assessment of Hydroxypropyl Methylcellulose, Propylene Glycol, Polysorbate 80, and Hydroxypropyl‐β‐Cyclodextrin for use in developmental and reproductive toxicology studies

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