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International Journal of Toxicology最新文献

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Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics. 用于生物治疗的猴子生殖毒理学测试的替代品。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-15 DOI: 10.1177/10915818231200859
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":null,"pages":null},"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}
引用次数: 0
Prunus Amygdalus Dulcis (Sweet Almond) Seed Meal. 甜杏仁籽粉。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-29 DOI: 10.1177/10915818231204244
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":null,"pages":null},"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}
引用次数: 0
Hexamidine and Hexamidine Diisethionate. 六脒和二异硫辛酸六脒。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-30 DOI: 10.1177/10915818231204273
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":null,"pages":null},"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}
引用次数: 0
Peanut Glycerides. 花生甘油。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-10-02 DOI: 10.1177/10915818231204277
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":null,"pages":null},"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}
引用次数: 0
Cottonseed Glyceride and Hydrogenated Cottonseed Glyceride. 棉籽甘油和氢化棉籽甘油。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-28 DOI: 10.1177/10915818231204275
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":null,"pages":null},"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}
引用次数: 0
PPG-11 and PPG-15 Stearyl Ether. PPG-11和PPG-15硬脂基醚。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-28 DOI: 10.1177/10915818231204265
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":null,"pages":null},"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}
引用次数: 0
Evaluation of the Carcinogenic Potential of Enarodustat (JTZ-951), a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, in 26-Week Tg.rasH2 Mouse Study and 2-Year Sprague-Dawley Rat Study. 缺氧诱导因子-丙氨酸羟化酶抑制剂Enarodustat (JTZ-951)在26周Tg中的致癌潜力评估。rasH2小鼠研究和2年Sprague-Dawley大鼠研究。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-07-22 DOI: 10.1177/10915818231190550
Yusuke Kemmochi, Kaoru Toyoda, Tomio Ishida, Yuzo Yasui, Toshiyuki Shoda
{"title":"Evaluation of the Carcinogenic Potential of Enarodustat (JTZ-951), a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, in 26-Week Tg.rasH2 Mouse Study and 2-Year Sprague-Dawley Rat Study.","authors":"Yusuke Kemmochi, Kaoru Toyoda, Tomio Ishida, Yuzo Yasui, Toshiyuki Shoda","doi":"10.1177/10915818231190550","DOIUrl":"10.1177/10915818231190550","url":null,"abstract":"<p><p>Enarodustat (JTZ-951) is an oral hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anemia with chronic kidney disease. Carcinogenicity of enarodustat was evaluated in a 26-week repeated oral dose study in Transgenic rasH2 (Tg.rasH2) mice and a 2-year repeated oral dose study in Sprague-Dawley (SD) rats. The highest dose levels were set at 6 mg/kg in the Tg.rasH2 mouse study and at 1 mg/kg in the SD rat study based on the maximum tolerated doses in the 3-month and 6-month dose-range finding studies, respectively. Enarodustat did not increase the incidence of any tumors or affect survival in these carcinogenicity studies. Pharmacology-related findings including increases in blood RBC parameters were observed at the highest dose levels for each study. The AUC-based exposure margins as protein-unbound drug base are 16.3-/26.0-fold multiple (males/females) for Tg.rasH2 mice and 1.6-/1.1-fold multiple for SD rats when compared with the estimated exposure in human with chronic kidney disease at 8 mg/day (maximum recommended human dose). In conclusion, enarodustat was considered to have no carcinogenic potential at the clinical dose.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9855224","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}
引用次数: 0
Assessing the Safety of MA-[D-Leu-4]-OB3, a Synthetic Peptide Leptin Mimetic: Two Pre-Clinical Toxicity Studies in Male and Female C57BL/6 Mice. MA-[D-Leu-4]- ob3对C57BL/6小鼠的两项临床前毒性研究
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-08-09 DOI: 10.1177/10915818231193634
Forrest Enemark, Zachary M Novakovic, Patricia Grasso
{"title":"Assessing the Safety of MA-[D-Leu-4]-OB3, a Synthetic Peptide Leptin Mimetic: Two Pre-Clinical Toxicity Studies in Male and Female C57BL/6 Mice.","authors":"Forrest Enemark, Zachary M Novakovic, Patricia Grasso","doi":"10.1177/10915818231193634","DOIUrl":"10.1177/10915818231193634","url":null,"abstract":"<p><p>Although the regulatory influence of leptin on energy balance, glycemic control, immunity, reproduction, and cognition is well established, its clinical application to common obesity and its co-morbidities has been limited by impaired transport across the blood-brain barrier, and tendencies to induce adverse side effects. To circumvent these drawbacks, MA-[D-Leu-4]-OB3, a leptin-related synthetic peptide that mimics the metabolic and neurotrophic effects of leptin in mouse models of genetic and non-genetic obesity, diabetes, and cognitive dysfunction, has been developed. This report presents the results of our initial efforts to assess the safety of orally delivered MA-[D-Leu-4]-OB3. Two pre-clinical studies were done in male and female C57BL/6 mice: a short-term study with a high dose of MA-[D-Leu-4]-OB3 (50 mg/kg/100 μL/day) and a dose-response study with 3 increasing concentrations of MA-[D-Leu-4]-OB3 (16.6, 50, and 150 mg/kg/100 μL/day). Body weight, food and water intake, glucose tolerance, and episodic memory were evaluated. Once-daily cage-side clinical observations were conducted to detect any physical or behavioral indicators of toxicity. Our results indicate that all metabolic and neurologic endpoints tested were either unaffected or improved by MA-[D-Leu-4]-OB3, and no clinical indicators of toxicity were evident. Together with our previously reported efficacy data, these results provide additional evidence supporting further development of this novel synthetic peptide leptin mimetic as a first-in-class peptide drug candidate for the treatment of a number of metabolic and/or cognitive dysfunctions in humans.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10457102","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}
引用次数: 0
BHT - Butylated Hydroxytoluene. BHT-丁基羟基甲苯。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-26 DOI: 10.1177/10915818231204256
Christina Burnett, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth
{"title":"BHT - Butylated Hydroxytoluene.","authors":"Christina Burnett, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204256","DOIUrl":"10.1177/10915818231204256","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 2002, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that BHT 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":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41120466","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}
引用次数: 0
Sodium Naphthalenesulfonate and Sodium Polynaphthalenesulfonate. 萘磺酸钠和聚萘磺酸钠。
IF 2.2 4区 医学
International Journal of Toxicology Pub Date : 2023-12-01 Epub Date: 2023-09-28 DOI: 10.1177/10915818231204267
Christina Burnett, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Lillian J Gill, Monice Fiume, Bart Heldreth
{"title":"Sodium Naphthalenesulfonate and Sodium Polynaphthalenesulfonate.","authors":"Christina Burnett, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Lillian J Gill, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818231204267","DOIUrl":"10.1177/10915818231204267","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2003, along with updated information regarding product types and concentrations of use, and confirmed that Sodium Naphthalenesulfonate and Sodium Polynaphthalenesulfonate are safe as cosmetic ingredients in the practices of use and concentration as described in this report in formulations intended to be applied to the skin.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41135892","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}
引用次数: 0
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