Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"PEG Soy Sterols.","authors":"Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204279","DOIUrl":"10.1177/10915818231204279","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in year 2000, along with updated information regarding product types and concentrations of use, and confirmed that PEG-5, -10, -16, -25, -30, and -40 Soy Sterol are safe as cosmetic ingredients in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"83S-85S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41130816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Recent Advances in Drug Discovery Toxicology.","authors":"Bowen Tang, Vijay More","doi":"10.1177/10915818231189659","DOIUrl":"10.1177/10915818231189659","url":null,"abstract":"<p><p>Major advances in scientific discovery and insights that stem from the development and use of new techniques and models can bring remarkable progress to conventional toxicology. Although animal testing is still considered as the \"gold standard\" in traditional toxicity testing, there is a necessity for shift from animal testing to alternative methods regarding the drug safety testing owing to the emerging state-of-art techniques and the proposal of 3Rs (replace, reduce, and refine) towards animal welfare. This review describes some recent research methods in drug discovery toxicology, including in vitro cell and organ-on-a-chip, imaging systems, model organisms (<i>C. elegans</i>, <i>Danio rerio</i>, and <i>Drosophila melanogaster</i>), and toxicogenomics in modern toxicology testing.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"535-550"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9834905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Erythorbic Acid and Sodium Erythorbate.","authors":"Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204257","DOIUrl":"10.1177/10915818231204257","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1999, along with updated information regarding product types and concentrations of use, and confirmed that Erythorbic Acid and Sodium Erythorbate are safe as cosmetic ingredients in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"37S-39S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41128742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lars van der Veen, Michael Schmitt, Marcel A Deken, Michael Lahn
{"title":"Non-Clinical Toxicology Evaluation of the Novel Non-ATP Competitive Oral PI3 Kinase Delta Inhibitor Roginolisib.","authors":"Lars van der Veen, Michael Schmitt, Marcel A Deken, Michael Lahn","doi":"10.1177/10915818231200419","DOIUrl":"10.1177/10915818231200419","url":null,"abstract":"<p><p>Roginolisib (IOA-244) is a novel, non-ATP competitive phosphoinositide-3-kinase (PI3K) delta inhibitor that regulates Akt/mTOR signaling. Roginolisib was administered once daily to rats and dogs in dose-range finding (DRF) and 4-week GLP toxicology studies. Free plasma levels of roginolisib exceeded the cellular target engagement IC<sub>90</sub> for PI3Kδ for ≥12 hours at doses of 5 mg/kg, the IC<sub>90</sub> for PI3Kβ for ≥2 hours at doses ≥15 mg/kg, and the IC<sub>50</sub> for PI3Kα for ≥2 hours at dose levels ≥45 mg/kg. Toxicity in rats occurred at doses ≥100 mg/kg. In dogs, we observed dose-dependent skin and gastrointestinal toxicity and doses ≥30 mg/kg had a greater incidence of mortality. Lymphoid tissue toxicity occurred in both species. Toxicities in dogs observed at the ≥15 mg/kg dose, affecting the digestive mucosa, liver, and skin, cleared after treatment cessation. Doses ≤75 mg/kg were tolerated in rats and the no-observed-adverse-effect-level (NOAEL) in rats was 15 mg/kg. Due to mainly epithelial lesions of the skin at 5 mg/kg and necrotizing damage of the intestinal epithelia at ≥15 mg/kg, no NOAEL was determined in dogs. However, the adverse effects observed in dogs at 5 mg/kg were considered monitorable and reversible in patients with advanced malignancies. Furthermore, the PK profile subsequently proved to be a decisive factor for achieving selective PI3Kδ inhibition without the toxicities observed in dogs. As the result of the unique PK profile of roginolisib, patients were able to take daily roginolisib without dose modification and showed pharmacodynamic PI3Kδ inhibition over several months without gastrointestinal or dermatologic toxicities.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"515-534"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10629260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10145048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alan M Hoberman, Kazushige Maki, Fumito Mikashima, Misaki Naota, Ronald L Wange, Janice A Lansita, Shawna L Weis
{"title":"Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.","authors":"Alan M Hoberman, Kazushige Maki, Fumito Mikashima, Misaki Naota, Ronald L Wange, Janice A Lansita, Shawna L Weis","doi":"10.1177/10915818231200859","DOIUrl":"10.1177/10915818231200859","url":null,"abstract":"<p><p>Embryofetal toxicity studies are conducted to support inclusion of women of childbearing potential in clinical trials and to support labeling for the marketed pharmaceutical product. For biopharmaceuticals, which frequently lack activity in the rodent or rabbit, the nonhuman primate is the standard model to evaluate embryofetal toxicity. These studies have become increasingly challenging to conduct due to the small number of facilities capable of performing them and a shortage of sexually mature monkeys. The low number of animals per group and the high rate of spontaneous abortion in cynomolgus monkeys further complicate interpretation of the data. Recent FDA guidance has proposed a weight of evidence (WoE) approach to support product labeling for reproductive toxicity of products intended to be used for the treatment of cancer (<i>Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations</i>), an approach that has also supported the approval of biotherapeutics for non-cancer indications. Considerations to determine the appropriateness and content of a WoE approach to support product labeling for embryofetal risk include known class effects in humans; findings from genetically modified animals with or without drug administration; information from surrogate compounds; literature-based assessments about the developmental role of the pharmaceutical target; and the anticipated exposure during embryofetal development. This paper summarizes the content of a session presented at the 42nd annual meeting at the American College of Toxicology, which explored the conditions under which alternative approaches may be appropriate to support product labeling for reproductive risk, and how sponsors can best justify the use of this approach.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"467-479"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10253749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christina L Burnett, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Prunus Amygdalus Dulcis (Sweet Almond) Seed Meal.","authors":"Christina L Burnett, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204244","DOIUrl":"10.1177/10915818231204244","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1983, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Prunus Amygdalus Dulcis (Sweet Almond) Seed Meal is safe for topical application to humans in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"93S-95S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41114360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Hexamidine and Hexamidine Diisethionate.","authors":"Priya Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204273","DOIUrl":"10.1177/10915818231204273","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2007, along with updated information regarding product types and concentrations of use, and confirmed that Hexamidine and Hexamidine Diisethionate are safe as cosmetic ingredients in the practices of use and concentration as described in this report if used at concentrations less than or equal to .10%.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"51S-52S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41121058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Peanut Glycerides.","authors":"Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204277","DOIUrl":"10.1177/10915818231204277","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2001, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Peanut Glycerides is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"79S-80S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41121398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth
{"title":"Cottonseed Glyceride and Hydrogenated Cottonseed Glyceride.","authors":"Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Susan Tilton, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204275","DOIUrl":"10.1177/10915818231204275","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2001, along with updated information regarding product types and concentrations of use, and confirmed that Cottonseed Glyceride and Hydrogenated Cottonseed Glyceride are safe as cosmetic ingredients in the practices of use and concentration as described in this report, provided that established and imposed limits on gossypol, heavy metals, and pesticide concentrations are not exceeded.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"27S-28S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41128888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pryia Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth
{"title":"PPG-11 and PPG-15 Stearyl Ether.","authors":"Pryia Cherian, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, Allan E Rettie, David Ross, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204265","DOIUrl":"10.1177/10915818231204265","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2001, along with updated information regarding product types and concentrations of use, and confirmed that PPG-11 and PPG-15 Stearyl Ether are safe as cosmetic ingredients in the practices of use and concentration as described in this report.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"81S-82S"},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41128889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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