Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth
{"title":"Safety Assessment of Acetyl Hexapeptide-8 Amide as Used in Cosmetics.","authors":"Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818251340391","DOIUrl":"10.1177/10915818251340391","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Acetyl Hexapeptide-8 Amide (synonymous with Acetyl Hexapeptide-8 (sans \"Amide\")) in cosmetic products; this ingredient is reported to function as a skin conditioning agent - miscellaneous in cosmetics. The Panel reviewed data relevant to the safety of this ingredient in cosmetic formulations, and concluded that Acetyl Hexapeptide-8 Amide is safe in cosmetics in the present practices of use at concentrations up to 0.005%. The Panel further concluded that the available data are insufficient to make a determination that Acetyl Hexapeptide-8 Amide is safe under the intended conditions of use in cosmetic formulations at concentrations greater than 0.005%.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"54S-63S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649434","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}
Monice M Fiume, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Bart Heldreth
{"title":"Safety Assessment of Caprylhydroxamic Acid as Used in Cosmetics.","authors":"Monice M Fiume, Wilma F Bergfeld, Donald V Belsito, Ronald A Hill, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Bart Heldreth","doi":"10.1177/10915818251343874","DOIUrl":"https://doi.org/10.1177/10915818251343874","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Caprylhydroxamic Acid as used in cosmetic formulations; this ingredient is reported to function as a chelating agent. Positive sensitization results that occurred with the use of a moisturizer containing Caprylhydroxamic Acid appeared to correlate with use on damaged skin. Therefore, the Panel cautioned against the use of Caprylhydroxamic Acid in a manner that would result in increased penetration. A quantitative risk assessment (QRA) was performed, using a weight-of-evidence no-expected-sensitization-induction-level (WoE NESIL) of 1056 μg/cm<sup>2</sup>. The Panel concluded that Caprylhydroxamic Acid is safe in cosmetics in the present practices of use and concentration described in this safety assessment.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"103S-123S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649436","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, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth
{"title":"Safety Assessment of Hydroxy Tetramethylpiperidine Oxide and Tris(Tetramethylhydroxypiperidinol) Citrate as Used in Cosmetics.","authors":"Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818251342562","DOIUrl":"https://doi.org/10.1177/10915818251342562","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydroxy Tetramethylpiperidine Oxide and Tris(Tetramethylhydroxypiperidinol) Citrate as used in cosmetic formulations. These ingredients are reported to function as an antioxidant and a light stabilizer, respectively. The Panel considered the available data and concluded that Hydroxy Tetramethylpiperidine Oxide and Tris(Tetramethylhydroxypiperidinol) Citrate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"92S-102S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649439","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}
Alice Akinsulie, Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth
{"title":"Safety Assessment of Glycerin Ethoxylates as Used in Cosmetics.","authors":"Alice Akinsulie, Preethi S Raj, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818251342558","DOIUrl":"10.1177/10915818251342558","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 8 glycerin ethoxylates, as used in cosmetic formulations. All of these ingredients are reported to function in cosmetics as skin-conditioning agents, and most are also reported to function as viscosity-decreasing agents. The Panel reviewed relevant data relating to the safety of these ingredients. The Panel concluded that these ingredients are safe in cosmetics in the present practices of use and concentration as described in this safety assessment when formulated to be non-irritating.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"75S-91S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649437","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}
Wilbur Johnson, 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, Monice Fiume, Bart Heldreth
{"title":"Titanium Complexes as Used in Cosmetics.","authors":"Wilbur Johnson, 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, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818251340382","DOIUrl":"10.1177/10915818251340382","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 5 titanium complexes as used in cosmetic products; these ingredients have the following reported functions in cosmetics: surface modifier (Isopropyl Titanium Triisostearate); colorant; humectant (Titanium Citrate); binder (Titanium Ethoxide); film former; opacifying agent (Titanium Isostearates); and preservative (Titanium Salicylate). The Panel reviewed relevant data relating to the safety of these ingredients in cosmetic formulations and issued the following separate conclusions. Isopropyl Titanium Triisostearate is safe in cosmetics in the present practices of use and concentration described in the safety assessment, when used as a surface modifier. The data are insufficient to determine the safety of Titanium Citrate, Titanium Ethoxide, Titanium Isostearates, and Titanium Salicylate.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"38S-53S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649441","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, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth
{"title":"Safety Assessment of Honey-Derived Ingredients as Used in Cosmetics.","authors":"Priya Cherian, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice Fiume, Bart Heldreth","doi":"10.1177/10915818251340381","DOIUrl":"https://doi.org/10.1177/10915818251340381","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 7 honey-derived ingredients. All of these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel considered the available data relating to the safety of these ingredients in cosmetic formulations. Because impurities, particularly pesticides and endotoxins, may be present in these ingredients, formulators should continue to use good manufacturing practices to monitor and limit these possible impurities. The Panel concluded the honey-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"5S-18S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649438","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}
Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth
{"title":"Safety Assessment of Vanilla as Used in Cosmetics.","authors":"Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818251342563","DOIUrl":"10.1177/10915818251342563","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 9 vanilla-derived ingredients as used in cosmetics. These ingredients are reported to function mostly as skin conditioning agents in cosmetic products. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents, and to avoid reaching levels that may be hazardous to consumers. Industry should continue to use good manufacturing practices to limit impurities. The Panel reviewed data relating to the safety of these ingredients and concluded that 7 ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing. The Panel further concluded that the available data are insufficient to make a determination of safety under the intended conditions of use in cosmetic formulations for Vanilla Planifolia Flower Extract and Vanilla Planifolia Leaf Cell Extract.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"19S-37S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649440","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, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth
{"title":"Safety Assessment of Basic Brown 17 as Used in Cosmetics.","authors":"Christina L Burnett, Wilma F Bergfeld, Donald V Belsito, David E Cohen, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818251342555","DOIUrl":"10.1177/10915818251342555","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Basic Brown 17, which is reported to function as a hair dye in cosmetic products. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Basic Brown 17 is safe in the present practices of use and concentration described in this safety assessment for use in hair dye products, and that the available data are insufficient to make a determination that Basic Brown 17 is safe under the intended conditions of use in other types of cosmetic products.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"64S-74S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649435","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}
Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth
{"title":"Safety Assessment of <i>Scutellaria baicalensis</i>-Derived Ingredients as Used in Cosmetics.","authors":"Wilbur Johnson, Wilma F Bergfeld, Donald V Belsito, Curtis D Klaassen, Daniel C Liebler, James G Marks, Lisa A Peterson, Ronald C Shank, Thomas J Slaga, Paul W Snyder, Monice M Fiume, Bart Heldreth","doi":"10.1177/10915818251350378","DOIUrl":"10.1177/10915818251350378","url":null,"abstract":"<p><p>The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 4 <i>Scutellaria baicalensis</i>-derived ingredients in cosmetic products; these ingredients are reported to have the following functions in cosmetics: antimicrobial agent, skin conditioning agent, abrasives, fragrance ingredients, skin protectants, and antioxidants. The Panel reviewed relevant data relating to the safety of these ingredients in cosmetic formulations, and concluded that Scutellaria Baicalensis Root Extract and Scutellaria Baicalensis Root Powder are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel also concluded that the available data are insufficient to make a determination of safety for Scutellaria Baicalensis Extract and Scutellaria Baicalensis Sprout Extract under the reported conditions of use in cosmetic formulations.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":"44 2_suppl","pages":"124S-138S"},"PeriodicalIF":1.2,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649429","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}
Daniel Rubio, Eric Zhu, Archie Thurston, Kathleen A Funk, Kristina A York, Carl L Dambkowski, Drew Badger
{"title":"Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys.","authors":"Daniel Rubio, Eric Zhu, Archie Thurston, Kathleen A Funk, Kristina A York, Carl L Dambkowski, Drew Badger","doi":"10.1177/10915818251355584","DOIUrl":"https://doi.org/10.1177/10915818251355584","url":null,"abstract":"<p><p>Interleukin-13 (IL-13) is a cytokine implicated in the pathophysiology of type 2 inflammatory diseases and is a clinically validated target in atopic dermatitis. APG777 is a humanized IgG1 monoclonal antibody with an optimized pharmacokinetic profile. APG777 has high affinity to IL-13 and includes a triple amino acid modification (the \"YTE\" modification) in its Fc region that is designed to extend its half-life. The current study examined the safety and potential toxicity of APG777 when given by once-weekly subcutaneous injection for 27 weeks to cynomolgus monkeys, and the potential reversibility of any findings following a 2-month recovery period. Toxicokinetic characteristics of APG777 were also determined. APG777 exhibited dose-proportional systemic exposure, with a half-life of approximately 28 days. No APG777-related adverse effects were noted in clinical observations, body weight, ophthalmology, electrocardiogram readings, neurologic parameters, hematology, coagulation, clinical chemistry, urinalysis, organ weights, or histopathology. Anti-drug antibodies were not detected in any APG777-exposed animals. Drug accumulation was evident over the study duration; however, there were no APG777-related adverse findings in any of the parameters analyzed. The no-observed-adverse-effect level (NOAEL) was 150 mg/kg/week. These findings provide preclinical evidence supporting continued clinical development of APG777 for IL-13-mediated diseases. The extended half-life of APG777 suggests potential benefits in reducing dosing frequency compared with existing IL-13-targeting therapies, which could improve treatment adherence and patient outcomes. The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"10915818251355584"},"PeriodicalIF":1.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144753328","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}
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
