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Authors:Ricardo Ochoa Abstract: International Journal of Toxicology, Ahead of Print.
Citation: International Journal of Toxicology PubDate: 2023-06-03T01:25:27Z DOI: 10.1177/10915818231181469
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Authors:William Jordan, Michael T. Sapko, Richard Siegel, Jonathan Javitt Abstract: International Journal of Toxicology, Ahead of Print. Agents that act at the N-methyl-D-aspartate receptor (NMDAR), such as ketamine, have gained increasing attention as rapid-acting antidepressants; however, their use has been limited by potential neurotoxicity. Recent FDA guidance requires a demonstration of safety on histologic parameters prior to the initiation of human studies. D-cycloserine (DCS) is a partial NMDA agonist that, along with lurasidone, is being investigated as a treatment for depression. The current study was designed to investigate the neurologic safety profile of DCS. To this end, female Sprague Dawley rats (n = 106) were randomly divided into 8 study groups. Ketamine was administered via tail vein infusion. DCS and lurasidone were administered via oral gavage in escalating doses to a maximum of 2000 mg/kg DCS. To ascertain toxicity, dose escalation with 3 different doses of D-cycloserine/lurasidone was given in combination with ketamine. MK-801, a known neurotoxic NMDA antagonist, was administered as a positive control. Brain tissue was sectioned and stained with H&E, silver, and Fluoro-Jade B stains. No fatalities were observed in any group. No microscopic abnormalities were found in the brain of animal subjects given ketamine, ketamine followed by DCS/lurasidone, or DCS/lurasidone alone. Neuronal necrosis, as expected, was seen in the MK-801 (positive control) group. We conclude that NRX-101, a fixed-dose combination of DCS/lurasidone, when administered with or without prior infusion of IV ketamine was tolerated and did not induce neurotoxicity, even at supratherapeutic doses of DCS. Citation: International Journal of Toxicology PubDate: 2023-05-25T03:16:26Z DOI: 10.1177/10915818231176971
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Authors:Priya A. Cherian, 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, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 8 dialkyl dimer dilinoleates as used in cosmetics. These ingredients are diesters formed from the reaction of straight-chained or branched alkyl alcohols and dilinoleic acid; these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel reviewed data relevant to the safety of these ingredients and concluded that Diisopropyl Dimer Dilinoleate, Dicetearyl Dimer Dilinoleate, Diisostearyl Dimer Dilinoleate, Diethylhexyl Dimer Dilinoleate, Dioctyldodecyl Dimer Dilinoleate, Ditridecyl Dimer Dilinoleate, Di-C16-18 Alkyl Dimer Dilinoleate, and Di-C20-40 Alkyl Dimer Dilinoleate are safe in cosmetics in the present practices of use and concentration described in this safety assessment. Citation: International Journal of Toxicology PubDate: 2023-05-16T06:12:44Z DOI: 10.1177/10915818231174437
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Authors:Chloe K. Stewart, Jillian Parker, Ruth Hwang, Melissa Vincent, Ernest Fung Abstract: International Journal of Toxicology, Ahead of Print. Historically, formaldehyde was used as a preservative in personal care products to extend product shelf-life; however, given its skin sensitization potential it has been phased out of use and replaced with formaldehyde-releasing preservatives, such as Dimethyloldimethyl hydantoin (DMDMH). A relationship has been established between positive patch test results following exposure to DMDMH and previous sensitization to formaldehyde. Upon direct contact with the skin, formaldehyde can react with skin proteins and cause an acute inflammatory reaction, which may progress to skin sensitization following repeated exposure. This quantitative risk assessment (QRA) aimed to assess the risk of skin sensitization induction following use of shampoo products containing the maximum allowable concentrations of DMDMH in formulation (1% w/v), translating to a free formaldehyde concentration of 0.02%. To determine a margin of safety (MOS) for exposure to DMDMH from use of shampoo products, consumer exposure levels (CEL) were estimated based on typical use scenarios and then benchmarked against an acceptable exposure level (AEL). The AEL was derived using a weight of evidence approach where a range of no expected sensitization induction levels (NESILs) was utilized. The MOS values for a shampoo product containing 1% DMDMH (.02% formaldehyde) was above 1 for the typical use scenario indicating a low likelihood of skin sensitization induction among healthy individuals. Thus, it can be concluded that shampoo products containing DMDMH at or below current allowable concentrations are not expected to increase the risk of skin sensitization induction. Citation: International Journal of Toxicology PubDate: 2023-05-13T07:06:00Z DOI: 10.1177/10915818231174429
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Authors:Udayan Apte, S. Satheesh Anand, Murali Badanthadka, Jaya Chilakapati, Lawrence R. Curtis, Vivek Dadhania, Sivarao V. Digavalli, Urmila Kodavanti, Prasada Rao Kodavanti, Pallavi Limaye, Raja Mangipudy, Subramanya N. Murthy, Binu Philip, Pratibha Rao, Sharmilee Sawant, Kartik Shankar, Vishal Vaidya, Tao Wang Abstract: International Journal of Toxicology, Ahead of Print.
Citation: International Journal of Toxicology PubDate: 2023-05-13T03:05:03Z DOI: 10.1177/10915818231174567
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Authors:Douglas A. Donahue, Leigh Ann Burns-Naas Abstract: International Journal of Toxicology, Ahead of Print. Certification in toxicology remains a subject of interest to those in the field, as evidenced by the number of presentations at major meetings and publications in the past decade. In 2009, Brock and colleagues summarized the certifications available in the field of toxicology and provided an international perspective of the pros and cons of gaining certification. Though that article has been viewed thousands of times, the certification processes have evolved over the past decade. Therefore, the purpose of the article is to build upon the prior work and present current information for toxicologists seeking certification with the American Board of Toxicology (DABT), Academy of Toxicological Sciences (ATS), as a European Registered Toxicologist (ERT), as a Diplomate, Japanese Society of Toxicology (DJSOT), and as a Diplomate of the Chinese Society of Toxicology (DCST). In addition, other certifications are presented, but available details are limited. Citation: International Journal of Toxicology PubDate: 2023-04-28T04:16:20Z DOI: 10.1177/10915818231171834
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Authors:Erin McDevitt, Lucie Henein, Anna Crawford, Sandeep Kondakala, Darian Young, Edward Meek, George E. Howell Abstract: International Journal of Toxicology, Ahead of Print. The overall prevalence of metabolic diseases such as type 2 diabetes (T2D) and associated co-morbidities have increased at an alarming rate in the United States and worldwide. There is a growing body of epidemiological evidence implicating exposure to persistent organic pollutants (POPs), including legacy organochlorine (OC) pesticides and their bioaccumulative metabolites, in the pathogenesis of metabolic diseases. Therefore, the goal of the present study was to determine if exposure to trans-nonachlor, a bioaccumulative OC pesticide contaminant, in concert with high fat diet intake induced metabolic dysfunction. Briefly, male Sprague Dawley rats were exposed to trans-nonachlor (.5 or 5 ppm) in either a low fat (LFD) or high fat diet (HFD) for 16 weeks. At 8 weeks of intake, trans-nonachlor decreased serum triglyceride levels in LFD and HFD fed animals and at 16 weeks compared to LFD fed animals. Interestingly, serum glucose levels were decreased by trans-nonachlor (5 ppm) in LFD fed animals at 16 weeks. Serum free fatty acids were increased by trans-nonachlor exposure (5 ppm) in LFD fed animals at 16 weeks. HFD fed animals displayed signs of hepatic steatosis including elevated liver triglycerides, liver enzymes, and liver lipid peroxidation which were not significantly altered by trans-nonachlor exposure. However, there was a trans-nonachlor mediated increase in expression of fatty acid synthase in livers of LFD fed animals and not HFD fed animals. Thus, the present data indicate exposure to trans-nonachlor in conjunction with LFD or HFD intake produces both diet and exposure dependent effects on lipid and glucose metabolism. Citation: International Journal of Toxicology PubDate: 2023-04-26T07:20:07Z DOI: 10.1177/10915818231170527
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Authors:David G. Serota Abstract: International Journal of Toxicology, Ahead of Print.
Citation: International Journal of Toxicology PubDate: 2023-04-12T07:33:32Z DOI: 10.1177/10915818231165980
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Authors:John A. Budny Abstract: International Journal of Toxicology, Ahead of Print.
Citation: International Journal of Toxicology PubDate: 2023-04-10T01:40:59Z DOI: 10.1177/10915818231168707
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Authors:Lillian C. Becker, Alice Akinsulie, 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, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. This is a safety assessment of 6 Eucalyptus globulus (eucalyptus)-derived ingredients as used in cosmetics. The reported functions of the Eucalyptus globulus (eucalyptus)-derived ingredients include abrasive, fragrance ingredient, and skin-conditioning agent (miscellaneous and occlusive). The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data on these ingredients. 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 use good manufacturing practices to limit impurities. The Panel concluded that Eucalyptus globulus (eucalyptus)-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing. Citation: International Journal of Toxicology PubDate: 2023-04-03T03:26:45Z DOI: 10.1177/10915818231164354
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Authors:David G. Serota Abstract: International Journal of Toxicology, Ahead of Print.
Citation: International Journal of Toxicology PubDate: 2023-03-31T10:35:18Z DOI: 10.1177/10915818231168099
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Authors:Lillian C. Becker, Ivan J. Boyer, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks; Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, Lillian J. Gill, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. This is a review of the scientific literature and unpublished data that are relevant for assessing the safety of 12 Helianthus annuus (sunflower)-derived ingredients as used in cosmetics. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid levels that may be hazardous to consumers. Helianthus annuus (sunflower)-derived ingredients may contain allergens, including 2S albumins and sesquiterpene lactones. Industry should use current good manufacturing practices (cGMP) to limit impurities and constituents of concern. The Expert Panel for Cosmetic Ingredient Safety (Panel) concluded that 9 Helianthus annuus (sunflower) seed- and flower-derived ingredients are safe as used in cosmetics in the present practices of use and concentration described in this safety assessment. The data are insufficient to evaluate the safety of 3 ingredients that are derived from other plant parts. Citation: International Journal of Toxicology PubDate: 2023-03-30T10:10:44Z DOI: 10.1177/10915818231162939
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Authors:Dexter W. Sullivan, Shayne C. Gad Abstract: International Journal of Toxicology, Ahead of Print. This is the eleventh in a series of salary surveys for toxicologists conducted at three-year intervals that began in 1988. Previous salary surveys were conducted in 1988, 1991, 1995, 1998, 2001, 2004, 2007 (which was posted electronically, but not published), 2012, 2016 and 2020. In addition to presenting the 2022 results, herein we are providing additional data and an analysis of the trends for employment and pay in toxicology over the last 35 years. The eleventh Triennial Toxicology Salary Survey was conducted as a joint project by the American College of Toxicology (ACT) and the Society of Toxicology (SOT). In addition to the two parent organizations, eight others (the Society for Birth Defects Research, the Society of Toxicologic Pathology, the Safety Pharmacology Society, the American Board of Toxicology (ABT), the Academy of Toxicological Sciences, the Roundtable of Toxicology Consultants, the Society of Environmental Toxicology and Chemistry (SETAC), and the Environmental Mutagenesis and Genomics Society) supported the effort by distributing the Survey Monkey-based instrument to their memberships. Surveys were not distributed to regional SOT chapters, causing there to be minimal responses below the doctorate and master's degree levels. It should be noted that there continues to be a significant increase in the number of individuals reporting six-figure incomes and in those receiving significant sums as bonuses. Citation: International Journal of Toxicology PubDate: 2023-03-22T12:03:49Z DOI: 10.1177/10915818231162914
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Authors:Alice Akinsulie, Christina 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, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 11 Cocos nucifera (coconut)-derived ingredients, most of which are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that 10 ingredients, derived from coconut flower, fruit, and liquid endosperm, are safe in cosmetics in the present practices of use and concentration described in this safety assessment, and that the available data are insufficient to make a determination of safety for Cocos Nucifera (Coconut) Shell Powder under the intended conditions of use in cosmetic formulations. Citation: International Journal of Toxicology PubDate: 2023-03-02T02:26:31Z DOI: 10.1177/10915818231157751
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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, Lillian J. Gill, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 9 Centella asiatica-derived ingredients, which reportedly function primarily as skin conditioning agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients. The Panel concluded that Centella Asiatica Extract, Centella Asiatica Callus Culture, Centella Asiatica Flower/Leaf/Stem Extract, Centella Asiatica Leaf Cell Culture Extract, Centella Asiatica Leaf Extract, Centella Asiatica Leaf Water, Centella Asiatica Meristem Cell Culture, Centella Asiatica Meristem Cell Culture Extract, and Centella Asiatica Root Extract are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, when formulated to be non-sensitizing. Citation: International Journal of Toxicology PubDate: 2023-02-22T10:59:50Z DOI: 10.1177/10915818231158272
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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, Lillian J. Gill, Bart Heldreth Abstract: International Journal of Toxicology, Ahead of Print. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 26 apple-derived ingredients, which reportedly function mostly as skin conditioning agents in cosmetic products. Because apple-derived ingredients may be obtained from different apple cultivars, the composition of ingredients derived from different cultivars should be similar to that of ingredients reviewed in this safety assessment. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel reviewed the available data to determine the safety of these ingredients and concluded that 21 of these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment. However, the Panel also determined that the available data are insufficient to determine the safety of Pyrus Malus (Apple) Root Extract, Pyrus Malus (or Malus Domestica) (Apple) Stem Extract, Malus Domestica (Apple) Callus Extract, and Malus Domestica (Apple) Oil. Citation: International Journal of Toxicology PubDate: 2023-02-21T04:21:06Z DOI: 10.1177/10915818231156873
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Authors:Zeynep Rana Guler, Umran Yilmaz, Kubra Uzunosmanoglu, Busra Ozturk, Mahmoud Abudayyak, Sibel Ozden Abstract: International Journal of Toxicology, Ahead of Print. Neonicotinoid insecticides, known for their selectivity and low mammalian toxicity, have been widely used in recent years as alternatives to organophosphate insecticides. Although neonicotinoids are generally considered to be safe, data show that they can cause harmful effects on human and environmental health. Due to the lack of information on their mechanism of toxicity, the effects of imidacloprid and thiamethoxam on DNA methylation as the most used marker for epigenetic effects were investigated in human neuroblastoma (SH-SY5Y) cells. The cells were exposed to imidacloprid and thiamethoxam in concentrations of 100, 200, and 500 μM for 24 hours, then global DNA methylation and expression of genes involved in global DNA methylation (DNMT1, DNMT3a and DNMT3b) were investigated. Global DNA methylation significantly increased after imidacloprid exposure at 100 μM, and thiamethoxam exposures at 200 µM and 500 μM (>1.5-fold). Imidacloprid significantly decreased the expression of DNMT1 and DNMT3a, whereas thiamethoxam did not cause any significant changes in the expression of DNMT genes. Our findings suggested that alteration in global DNA methylation may be involved in the toxic mechanisms of imidacloprid and thiametoxam. Citation: International Journal of Toxicology PubDate: 2023-02-01T04:40:42Z DOI: 10.1177/10915818231154470
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Authors:Yuval Ramot, Yakir Rottenberg, Abraham J. Domb, Michael J. Kubek, Kevin D. Williams, Abraham Nyska Abstract: International Journal of Toxicology, Ahead of Print. Thyrotropin-releasing hormone (TRH) and TRH-like peptides carry a therapeutic potential for neurological conditions. Nanoparticles (NP) made of the biodegradable polymer, Poly(Sebacic Anhydride) (PSA), have been developed to carry TRH, intended for intranasal administration to patients. There is limited information on the safety of biodegradable polymers when given intranasally, and therefore, we have performed two preclinical safety and toxicity studies in cynomolgus monkeys and rats using TRH-PSA nanoparticles. The rats and monkeys were dosed intranasally for 42 days or 28 days, respectively, and several animals were followed for additional 14 days. Animals received either placebo, vehicle (PSA), or different concentrations of TRH-PSA. No systemic adverse effects were seen. Changes in T3 or T4 concentrations were observed in some TRH-PSA-treated animals, which did not have clinical or microscopic correlates. No effect was seen on TSH or prolactin concentrations. In the monkey study, microscopic changes in the nasal turbinates were observed, which were attributed to incidental mechanical trauma caused during administration. Taken together, the TRH-loaded PSA NPs have proven to be safe, with no local or systemic adverse effects attributed to the drug loaded nanoparticles. These findings provide additional support to the growing evidence of the safety of peptide-loaded NPs for intranasal delivery and pave the way for future clinical trials in humans. Citation: International Journal of Toxicology PubDate: 2023-01-12T08:25:36Z DOI: 10.1177/10915818231152613
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Authors:Sachil Kumar, Siddaraj Darshan, Tulsidas R. Baggi Abstract: International Journal of Toxicology, Ahead of Print. Depression is one of the most prevalent but severe of mental disorders, affecting thousands of individuals across the globe. Depression, in its most extreme form, may result in self-harm and an increased likelihood of suicide. Antidepressant drugs are first-line medications to treat mental disorders. Unfortunately, these medications are also prescribed for other in- and off-label conditions, such as deficit/hyperactivity disorders, attention disorders, migraine, smoking cessation, eating disorders, fibromyalgia, pain, and insomnia. This results in an increase in the use of antidepressant medications, leading to clinical and forensic overdose cases that could be either accidental or deliberate. The findings revealed that people who used antidepressants had a 33% greater chance of dying sooner than expected, compared to those who did not take the medications. Analytical techniques for precisely identifying and detecting antidepressants and their metabolic products in a variety of biological matrices are greatly needed to be developed and made available. Hence, this study attempts to discuss various analytical techniques used to identify and determine antidepressants in various biological matrices, which include urine, blood, oral fluid (saliva), and tissues, which are commonly encountered in clinical and forensic science laboratories. Citation: International Journal of Toxicology PubDate: 2023-01-11T09:51:32Z DOI: 10.1177/10915818221150779
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