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}
Anthony Dayan, Peter Pressman, Thomas Blackburn, Norbert Kaminski, Samuel Cohen, A Wallace Hayes
{"title":"A Commentary: Looking Back and Looking Sideways.","authors":"Anthony Dayan, Peter Pressman, Thomas Blackburn, Norbert Kaminski, Samuel Cohen, A Wallace Hayes","doi":"10.1177/10915818251328037","DOIUrl":"10.1177/10915818251328037","url":null,"abstract":"<p><p>It has been said that \"too much confidence cannot be placed on the lessons of history.\" We suggest that this declaration is particularly salient for the dynamic field of toxicology. The intersection of historical trends and technological developments within and outside the discipline is briefly considered as they have shaped what we study and what we do. Most importantly, perhaps, both individually and collectively, these elements also highlight cautions and define challenges that toxicology must embrace to continue to thrive and contribute to the scientific enterprise and public health.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"346-352"},"PeriodicalIF":1.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811449","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":"Safety Evaluation of N-<i>trans</i>-caffeoyltyramine Derived From a Strain of <i>Yarrowia lipolytica</i> Through Precision Fermentation.","authors":"Sungwon Lee, Srinivas Seekallu, Suresh Babu Venkataramaiah, Chandrashekar Mataguru Doreswamy, Mohan Cheluru Umesh, Sandeep Malleshappa, Sajeev Justin Dev, Ganadhal Puttaramaiah Chethankumara, Nagaraju Lohith, Gajanan Rajpal Deshmukh, Brian Premkumar, Brinda Mahadevan","doi":"10.1177/10915818251338788","DOIUrl":"10.1177/10915818251338788","url":null,"abstract":"<p><p>N-<i>trans</i>-caffeoyltyramine (NCT) is a phenolic hydroxycinnamic acid amide naturally present in many plant crop species and is associated with immune response and many development processes. Little research has been done on the potential safety of NCT for use as an ingredient in conventional foods and beverages. This study assessed the safety of NCT derived from caffeic acid and produced using a genetically engineered strain <i>Yarrowia lipolytica</i> strain 3599_7 via precision fermentation through in vitro genotoxicity assays and a 90-day dietary oral toxicity study in rats. The Ames test was performed in bacterial strains and the highest dose tested was 5000.0 μg/plate in the presence and absence of S9. The in vitro mammalian micronucleus test was conducted in human peripheral blood lymphocytes in culture exposed to NCT at predetermined concentrations in the absence (4-hour and 24-hour exposure) and presence (4-hour exposure) of S9. NCT was not genotoxic as evident from the Ames and the in vitro micronucleus assay. NCT exhibited no adverse effects in the 90-day oral toxicity study up to the highest dose tested, where the no-observed-adverse-effect level was 1427 and 1983 mg/kg body weight/day in males and females, respectively.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"328-345"},"PeriodicalIF":1.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002778","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}
Tae-Woo Kim, Tae-Kyung Kim, Hye-Joon Park, Mu-Jin Lee, Sung-Jin Park, Laehong Jo, Yong-Hoon Lee, Yong-Seok Kim, Byeongwoo Ahn
{"title":"Comparative Analyses of the Influences of Vehicles on Selected Biological Parameters Following Single-Dose Oral Administration in Sprague-Dawley Rats.","authors":"Tae-Woo Kim, Tae-Kyung Kim, Hye-Joon Park, Mu-Jin Lee, Sung-Jin Park, Laehong Jo, Yong-Hoon Lee, Yong-Seok Kim, Byeongwoo Ahn","doi":"10.1177/10915818251330516","DOIUrl":"10.1177/10915818251330516","url":null,"abstract":"<p><p>Various types of vehicles are used in non-clinical studies to administer treatment substances to experimental animals. It is recognized that these vehicle substances can influence animal physiology to some extent. Studies are designed to minimize the effects of vehicle substances to ensure reliable results. However, research on the biological effects of these vehicles is still inadequate. This study aims to assess the effects of vehicles on selected biological parameters (body weight, food consumpton, water consumption, functional observational battery, clinical pathology, and organ weights) and to establish reference ranges for these parameters to aid in historical control data. A total of 1,528 Sprague-Dawley rats were used in this study, exposed to commonly utilized vehicles such as distilled water, corn oil, dimethyl sulfoxide (DMSO), polyethylene glycol 400, carboxymethyl cellulose, and methyl cellulose via oral dosing at 5 mL/kg body weight per day, consistent with the dosing regimen employed in the toxicity tests included in this study. Significant changes were observed in the red blood cell counts and organ weights with DMSO treatment, whereas other vehicles induced only minor changes. This study highlights the importance of careful vehicle selection in non-clinical trials to eliminate their biological impact.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"259-286"},"PeriodicalIF":1.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002648","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":"Effects of Solvent Dimethyl Sulfoxide Invites a Rethink of Its Application in Amyloid Beta Cytotoxicity.","authors":"Yanhong Fu, Jiafa Zhang, Canhong Yang, Yuanyuan Wang, Yunzhu Yang, Pingming Qiu, Weibing Xie, Shufen Zhang, Tianming Lǚ","doi":"10.1177/10915818251338235","DOIUrl":"10.1177/10915818251338235","url":null,"abstract":"<p><p>Dimethyl sulfoxide (DMSO) is commonly used as a solvent for preparing amyloid-beta (Aβ) peptides implicated in Alzheimer's disease. While considered relatively non-toxic at low concentrations, DMSO itself may exert biological effects that could confound experimental outcomes, especially for weakly cytotoxic substances like Aβ. Seven brain cell types (BV-2, N2a, SH-SY5Y, U87, neurons, astrocytes, microglia) were treated with varying DMSO concentrations or Aβ1-42 oligomers/protofibrils/fibrils prepared using DMSO. Cell viability was assessed by CCK-8 and LDH assays. Matched DMSO controls were prepared alongside Aβ treatments to delineate solvent effects. Low DMSO concentrations (0.0625-0.015625%) exhibited hormetic cytoprotective and growth-promoting effects, while higher concentrations (≥2%) were cytotoxic. Importantly, these hormetic solvent effects confounded the measurement of Aβ cytotoxicity. By accounting for matched DMSO controls, the study revealed that Aβ fibril toxicity may have been underestimated due to the cytoprotective solvent effects of low DMSO concentrations used in their preparation. In conclusion, DMSO exhibits complex hormetic dose-responses that can significantly influence experimental outcomes, especially for weakly cytotoxic agents like Aβ. Rigorous solvent controls are crucial to delineate genuine substance effects from potential solvent confounds and avoid erroneous interpretations.</p>","PeriodicalId":14432,"journal":{"name":"International Journal of Toxicology","volume":" ","pages":"297-313"},"PeriodicalIF":1.2,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078081","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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