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International Journal of Toxicology

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https://www.readbyqxmd.com/read/30282506/embracing-transparency-through-data-sharing
#1
Stéphanie Boué, Michael Byrne, A Wallace Hayes, Julia Hoeng, Manuel C Peitsch
Low rates of reproducibility and translatability of data from nonclinical research have been reported. Major causes of irreproducibility include oversights in study design, failure to characterize reagents and protocols, a lack of access to detailed methods and data, and an absence of universally accepted and applied standards and guidelines. Specific areas of concern include uncharacterized antibodies and cell lines, the use of inappropriate sampling and testing protocols, a lack of transparency and access to raw data, and deficiencies in the translatability of findings to the clinic from studies using animal models of disease...
October 3, 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30244632/-not-everything-that-shakes-is-a-seizure-making-the-determination-of-test-article-induced-convulsions-in-toxicology-studies
#2
David V Gauvin, Zachary J Zimmermann, Joshua Yoder, Theodore J Baird
Spontaneous unexpected events occasionally develop during the course of rodent preclinical toxicology studies. The presentation of serious adverse events on animal studies may require notification of these events to the Food and Drug Administration if the events are most likely the direct result of test article administration. Classical conditioning of emotional responses may occur over the course of a repeat-dose study and clinical observation calls of "convulsions" are reported to the study director and/or staff veterinarians...
September 24, 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30236031/editor-s-note
#3
Mary Beth Genter
No abstract text is available yet for this article.
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30235961/safety-assessment-of-pegs-cocamine-and-related-ingredients-as-used-in-cosmetics
#4
Ivan Boyer, Christina L 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, Bart Heldreth
The Cosmetic Ingredient Review Expert Panel assessed the safety of 47 polyethylene glycols (PEGs) cocamine and related ingredients, which are reported to function mostly as surfactants and antistatic agents. The Panel reviewed the relevant data and developed a framework to satisfy previously identified data deficiencies for this group of materials as well as extend the scope of related materials covered by the analysis. The irritation potential of these ingredients is consistent with the surface active properties that are characteristic of surfactants...
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30235960/safety-assessment-of-peg-150-pentaerythrityl-tetrastearate-as-used-in-cosmetics
#5
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, F Alan Andersen, Bart Heldreth
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of polyethylene glycol (PEG)-150 pentaerythrityl tetrastearate, which functions as a viscosity-increasing agent-aqueous in cosmetic products and is being used at concentrations up to 5%. Given the chemical structure (large molecule), skin penetration is not likely. The available toxicity data and the low ingredient use concentrations suggest that systemic toxicity would not be likely even if percutaneous absorption were to occur. Additionally, the negative human repeated insult patch test data on the undiluted ingredient were deemed sufficient for evaluating skin irritation and sensitization potential...
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30235959/safety-assessment-of-tocopherols-and-tocotrienols-as-used-in-cosmetics
#6
Monice M Fiume, 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, F Alan Andersen, Bart Heldreth
The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 14 tocopherols and tocotrienols and concluded these ingredients are safe as used in cosmetics. The tocopherols are reported to function in cosmetics as antioxidants or skin-conditioning agents; in contrast, tocotrienols are not reported to function as an antioxidants in cosmetics but as a light stabilizer, oral care agent, or skin-conditioning agent. The Panel reviewed the new and existing animal and clinical data to determine the safety of these ingredients and found it appropriate to extrapolate the existing information to conclude on the safety of all the tocopherols and tocotrienols...
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30134762/paradoxical-protective-effect-of-perfluorooctanesulfonic-acid-against-high-fat-diet-induced-hepatic-steatosis-in-mice
#7
Ian Huck, Kevin Beggs, Udayan Apte
Perfluorooctanesulfonic acid (PFOS) is a persistent organic pollutant with worldwide bioaccumulation due to a very long half-life. Perfluorooctanesulfonic acid exposure results in significant hepatic effects including steatosis, proliferation, hepatomegaly, and in rodents, carcinogenesis. The objective of this study was to determine whether PFOS exposure exacerbates nonalcoholic fatty liver disease and nonalcoholic steatohepatitis pathogenesis. Eight-week-old male C57BL/6 J mice (n = 5 per group) were fed ad libitum normal chow diet (ND) alone, 60% high-fat diet (HFD) alone, ND + PFOS, and HFD + PFOS (0...
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30134751/characterization-of-the-testicular-toxicity-of-3-nitro-1-2-4-triazol-5-one-and-2-4-dinitroanisole-in-rats-rattus-norvegicus
#8
Emily May Lent, Anna B Mullins, Anthony D May, Cary L Honnold, Kenneth E Despain
Nitrotriazolone (3-nitro-1,2,4-triazol-5-one; NTO) and dinitroanisole (2,4-dinitroanisole; DNAN), insensitive energetic materials used in explosive formulations, have induced testicular toxicity and oligospermia in repeated-dose oral toxicity tests. To identify the target site of testicular toxicity of NTO and DNAN, Sprague Dawley rats were orally dosed with NTO (500 mg/kg/d) or DNAN (50 or 100 mg/kg/d) in corn oil for 1, 3, 7, or 14 days. Degeneration of germinal epithelium occurred in multiple tubule stages on days 7 and 14 in treated rats...
September 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30016916/how-did-i-ever-get-here-the-2018-mildred-s-christian-award-winner
#9
Linda S Birnbaum
No abstract text is available yet for this article.
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/30016915/editor-s-note
#10
Mary Beth Genter
No abstract text is available yet for this article.
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29916280/similar-and-differential-canonical-pathways-and-biological-processes-associated-with-multiwalled-carbon-nanotube-and-asbestos-induced-pulmonary-fibrosis-a-1-year-postexposure-study
#11
Julian M Dymacek, Brandi N Snyder-Talkington, Rebecca Raese, Chunlin Dong, Salvi Singh, Dale W Porter, Barbara Ducatman, Michael G Wolfarth, Michal E Andrew, Lori Battelli, Vincent Castranova, Yong Qian, Nancy L Guo
Respiratory exposure to multiwalled carbon nanotubes (MWCNT) or asbestos results in fibrosis; however, the mechanisms to reach this end point may be different. A previous study by our group identified pulmonary effects and significantly altered messenger RNA (mRNA) signaling pathways following exposure to 1, 10, 40, and 80 µg MWCNT and 120 µg crocidolite asbestos on mouse lungs over time at 1-month, 6-month, and 1-year postexposure following pulmonary aspiration. As a continuation to the above study, this current study took an in-depth look at the signaling pathways involved in fibrosis development at a single time point, 1 year, and exposure, 40 µg MWCNT, the lowest exposure at which fibrosis was pathologically evident...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29898631/development-of-a-phototoxicity-testing-strategy-for-accurate-photosafety-evaluation-of-pharmaceuticals-based-on-the-assessment-of-possible-melanin-binding-effects
#12
Jelle Reinen, Pieter van Sas, Ton van Huygevoort, Leticia Rubio, Kevin Scase, Mira Wenker
Drug-induced phototoxicity occurs when drugs absorb natural sunlight, leading to chemical reactions causing cellular damage. Distribution to light-exposed tissues is critical and is enhanced by binding to melanin. The International Council on Harmonization S10 guidance document on photosafety evaluation of pharmaceuticals states that although nonpigmented skin tends to be more sensitive than pigmented skin, pigmented skin models should be considered for drugs that bind significantly to melanin. In this study, an in vitro melanin-binding assay was evaluated as prescreening tool for animal model selection...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29890881/comparative-assessment-on-mechanism-underlying-renal-toxicity-of-commercial-formulation-of-roundup-herbicide-and-glyphosate-alone-in-male-albino-rat
#13
Gabriel A Dedeke, Folarin O Owagboriaye, Kehinde O Ademolu, Olanrewaju O Olujimi, Adeyinka A Aladesida
There have been major concerns that the nephrotoxicity of commercial formulations of Roundup herbicide is due to the active ingredient glyphosate. We therefore investigated and compared the mechanisms underlining the nephrotoxicity of Roundup herbicide and glyphosate alone in rat. Fifty-six adult male rats randomized into 7 groups of 8 rats per group were exposed to Roundup formulation and glyphosate alone daily by gavage at 3.6, 50.4, and 248.4 mg/kg body weight (bw) of glyphosate concentrations for 12 weeks with distilled water administered to the control group...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29862868/inhibition-of-mast-cell-degranulation-with-cromolyn-sodium-exhibits-organ-specific-effects-in-polycystic-kidney-pck-rats
#14
Lu Jiang, Pingping Fang, Seth Septer, Udayan Apte, Michele T Pritchard
Autosomal recessive polycystic kidney disease (ARPKD) is a monogenic disease characterized by development of hepatorenal cysts, pericystic fibrosis, and inflammation. Previous studies show that mast cell (MC) mediators such as histamine induce proliferation of cholangiocytes. We observed robust MC accumulation around liver cysts, but not kidney cysts, in polycystic kidney (PCK) rats (an animal model of ARPKD). Therefore, we hypothesized that MCs contribute to hepatic cyst growth in ARPKD. To test this hypothesis, we treated PCK rats with 1 of 2 different MC stabilizers, cromolyn sodium (CS) or ketotifen, or saline...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29862856/toxicological-assessment-of-venlafaxine-acute-and-subchronic-toxicity-study-in-rats
#15
Melad G Paulis, Essam M Hafez, Nashwa F El-Tahawy, Mohmed K M Aly
Antidepressants are the most commonly prescribed drugs for psychiatric treatment, and venlafaxine (VEN) is one of the most popular options. Venlafaxine is a nontricyclic dual-acting serotonin-norepinephrine reuptake inhibitor. Although an increased incidence of acute toxicity and addiction has been reported, controlled studies examining its toxic effects on different organs are still lacking. This study investigated the possible toxic effects of VEN on the liver, kidney, and gastric tissues. Three groups of rats were administered saline, a single LD50 dose (350 mg/kg), or 100 mg/kg VEN daily, followed by increases in the dose of 50 mg/kg every 10 days for 30 days (about 10 times the therapeutic doses)...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29734825/skin-and-eye-irritation-assessment-of-oil-palm-elaeis-guineensis-leaf-extract-for-topical-application
#16
Nor Zuliana Yusof, Siti Salwa Abd Gani, Zafarizal Aldrin Azizul Hasan, Zainab Idris
Many types of phytochemicals have been found to be present in oil palm leaf and could potentially be used as functional ingredients for skincare product. However, as of today, there is no published report on hazard identification and safety assessment of oil palm ( Elaeis guineensis) leaf extract (OPLE), particularly on skin and eye irritation. In this study, potential hazard of OPLE on skin and eye irritation was evaluated as an initial step to the safety assessment of OPLE. In vitro cell viability study of OPLE on normal human dermal fibroblasts showed that OPLE was nontoxic to the cells with percentage viability more than 90% after 24 and 48 hours of incubation...
July 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29761732/safety-assessment-of-polyether-lanolins-as-used-in-cosmetics
#17
Lillian C Becker, 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, F Alan Andersen, Bart Heldreth
The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group...
May 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29761731/safety-assessment-of-alkyl-betaines-as-used-in-cosmetics
#18
Christina L 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, F Alan Andersen, Bart Heldreth
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 11 alkyl betaines as used in cosmetics. These ingredients are reported to function as hair and skin conditioning agents, antistatic agents, surfactants-cleansing agents, and viscosity-increasing agents in cosmetic products. Although there are data gaps, the shared chemical core structure, similar functions and concentrations of use in cosmetics, and the expected similarities in physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group...
May 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29761730/safety-assessment-of-tromethamine-aminomethyl-propanediol-and-aminoethyl-propanediol-as-used-in-cosmetics
#19
Lillian C Becker, 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
The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of tromethamine, aminomethyl propanediol, and aminoethyl propanediolas used in cosmetics. All 3 ingredients are reported to function in cosmetics as pH adjusters, and tromethamine and aminomethyl propanediol are also reported to function as fragrance ingredients. The Panel reviewed relevant animal and human data related to these ingredients, along with a previous safety assessment of aminomethyl propanediol. The Panel concluded that tromethamine, aminomethyl propanediol, and aminoethyl propanediol are safe in cosmetics in the practices of use and concentration as given in this safety assessment...
May 2018: International Journal of Toxicology
https://www.readbyqxmd.com/read/29761729/safety-assessment-of-magnesium-sulfate-as-used-in-cosmetics
#20
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, F Alan Andersen, Bart Heldreth
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of magnesium sulfate, which functions as a bulking agent in cosmetic products and is reportedly used at concentrations up to 11% and 25% in leave-on and rinse-off products, respectively. The Panel noted that the history of safe medical use of magnesium sulfate provides further confidence that there are no significant toxicity concerns relating to systemic exposure to this ingredient after cosmetic product application. Furthermore, the extensive clinical experience of the Panel, including the results of numerous patch tests, indicates that magnesium salts do not have the potential to induce sensitization...
May 2018: International Journal of Toxicology
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