International Journal of Toxicology This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Tavaborole, a Novel Boron-Containing Small Molecule Pharmaceutical Agent for Topical Treatment of Onychomycosis: II. Prenatal and Postnatal Developmental Toxicity and Maternal Function Study
Tavaborole is a topical antifungal agent approved by the US Food and Drug Administration for the treatment of toenail onychomycosis. The effects of tavaborole on gestation, parturition (delivery, labor), offspring development, and survival during the perinatal and postnatal periods were assessed in mated female rats. Females (F0 generation) were administered single daily oral (gavage) doses of 15, 60, or 100 mg/kg/d from gestation day 6 through lactation day 20. The females were allowed to deliver naturally and rear their offspring until lactation day 21, at which time the F0 females were euthanized. One male and female fr...
Source: International Journal of Toxicology - September 20, 2016 Category: Toxicology Authors: Ciaravino, V., Coronado, D., Lanphear, C., Hoberman, A., Chanda, S. Tags: Drug Development and Safety Evaluation Source Type: research

Tavaborole, a Novel Boron-Containing Small Molecule Pharmaceutical Agent for Topical Treatment of Onychomycosis: I. Reproductive and Developmental Toxicity Studies
Tavaborole is a topical antifungal agent approved by the US Food and Drug Administration for the treatment of toenail onychomycosis. As part of the nonclinical development program, reproductive and developmental toxicity studies were conducted (rat oral fertility and early embryonic development, rat (oral) and rabbit (dermal) embryo–fetal development). There were no effects on fertility or reproductive performance at doses up to 300 mg/kg/d (107 times the maximum recommended human dose [MRHD] based on mean area under the plasma concentration–time curve comparisons). In the rat embryo–fetal development tox...
Source: International Journal of Toxicology - September 20, 2016 Category: Toxicology Authors: Ciaravino, V., Coronado, D., Lanphear, C., Hoberman, A., Chanda, S. Tags: Drug Development and Safety Evaluation Source Type: research

Exploratory Studies With BT-11: A Proposed Orally Active Therapeutic for Crohns Disease
Lanthionine synthetase cyclase-like receptor 2 (LANCL2) is a novel therapeutic target for Crohn’s disease (CD). BT-11 is a small molecule that binds LANCL2, is orally active, and has demonstrated therapeutic efficacy in 3 validated mouse models of colitis at doses as low as 8 mg/kg/d. Exploratory experiments evaluated BT-11 in male Harlan Sprague Dawley rats with a single oral dose of 500 mg/kg and 80 mg/kg/d for 14 days (n = 10 rats dosed/group). Treated and control rats were observed for behavioral detriments, and blood and tissues were collected for clinical pathology and histopathological examination. A functiona...
Source: International Journal of Toxicology - September 20, 2016 Category: Toxicology Authors: Bissel, P., Boes, K., Hinckley, J., Jortner, B. S., Magnin-Bissel, G., Werre, S. R., Ehrich, M., Carbo, A., Philipson, C., Hontecillas, R., Philipson, N., Gandour, R. D., Bassaganya-Riera, J. Tags: Drug Development and Safety Evaluation Source Type: research

Current Topics in Postnatal Behavioral Testing
This article summarizes the proceedings of a symposium held during the 2015 American College of Toxicology annual meeting and includes a discussion of the current status of DNT testing as well as potential issues and recommendations. Topics include the regulatory context for DNT testing; study design and interpretation; behavioral test selection, including a comparison of core learning and memory systems; age of testing; repeated testing of the same animals; use of alternative animal models; impact of findings; and extrapolation of animal results to humans. Integration of the regulatory experience and scientific concepts p...
Source: International Journal of Toxicology - September 20, 2016 Category: Toxicology Authors: Henck, J. W., Elayan, I., Vorhees, C., Fisher, J. E., Morford, L. L. Tags: ACT Annual Meeting Symposium Overview Articles Source Type: research

The First Cut Is the Deepest: The History and Development of Safe Treatments for Wound Healing and Tissue Repair
This article provides a synopsis on the symposium presentations focusing on how wounds were traditionally treated, what models and pathology endpoints exist to study wound healing, special considerations for wound healing studies, an overview of regulatory aspects of new pharmaceutical and medical device development, and the clinical relevance of such models. The clinical treatment of small and large wounds is also considered. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - September 20, 2016 Category: Toxicology Authors: Hobson, D. W., Schuh, J. C. L., Zurawski, D. V., Wang, J., Arbabi, S., McVean, M., Funk, K. A. Tags: ACT Annual Meeting Symposium Overview Articles Source Type: research

Safety Assessment of Alkyl PEG/PPG Ethers as Used in Cosmetics
The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 131 alkyl polyethylene glycol (PEG)/polypropylene glycol ethers as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating. Most of the alkyl PEG/PPG ethers included in this review are reported to function in cosmetics as surfactants, skin-conditioning agents, and/or emulsifying agents. The alkyl PEG/PPG ethers share very similar physiochemical properties as the alkyl PEG ethers, which were reviewed previously by the CIR Expe...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Fiume, M. M., Heldreth, B., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., Andersen, F. A. Tags: Articles Source Type: research

Safety Assessment of Nitrocellulose and Collodion as Used in Cosmetics
The Cosmetic Ingredient Review Expert Panel (the Panel) assessed the safety of nitrocellulose and collodion as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration in cosmetic formulations. Both ingredients are used almost exclusively in nail product formulations. The maximum concentration of use of nitrocellulose in nail polish and enamels is 22%; for collodion, the maximum reported concentration of use in nail polish and enamel is 14%. The Panel reviewed available animal and clinical data in making its determination of safety. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Fiume, M. M., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., Andersen, F. A. Tags: Articles Source Type: research

Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics
The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety. (Source: International Journal of Toxicology)
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Fiume, M. M., Heldreth, B., Bergfeld, W. F., Belsito, D. V., Hill, R. A., Klaassen, C. D., Liebler, D. C., Marks, J. G., Shank, R. C., Slaga, T. J., Snyder, P. W., Andersen, F. A. Tags: Articles Source Type: research

Book Review: Biomaterials, Medical Devices, and Combination Products--Biocompatibility Testing and Safety Assessment
(Source: International Journal of Toxicology)
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Mullis, D. W. Tags: Book Review Source Type: research

In Vivo and In Vitro Arsenic Exposition Induces Oxidative Stress in Anterior Pituitary Gland
Inorganic arsenic (iAs) is at the top of toxic metalloids. Inorganic arsenic-contaminated water consumption is one of the greatest environmental health threats worldwide. Human iAs exposure has been associated with cancers of several organs, neurological disorders, and reproductive problems. Nevertheless, there are no reports describing how iAs affects the anterior pituitary gland. The aim of this study was to investigate the mechanisms involved in iAs-mediated anterior pituitary toxicity both in vivo and in vitro. We showed that iAs administration (from 5 to 100 ppm) to male rats through drinking water increased messenger...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Ronchetti, S. A., Bianchi, M. S., Duvilanski, B. H., Cabilla, J. P. Tags: Regular Article Source Type: research

The MTT and Crystal Violet Assays: Potential Confounders in Nanoparticle Toxicity Testing
The toxicological effects of nanoparticles (NPs) on humans, animals, and environment are largely unknown. Assessment of NPs cytotoxicity depends on the choice of the test system. Due to NPs optical activity and absorption values, they can influence the classical cytotoxicity assay. Eight NPs were spiked in the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) and crystal violet assays and tested with HaCaT human skin cells. The MTT assay standard curve optical density (OD) measurements were altered by the presence of trisilanol phenyl and trisilanol isooctyl polyhedral oligomeric silsesquioxane particles. ...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Almutary, A., Sanderson, B. J. S. Tags: Regular Articles: Nanomaterials and Nanotoxicology Source Type: research

Nonclinical Safety and Toxicokinetics of MnTnBuOE-2-PyP5+ (BMX-001)
BMX-001, a manganese porphyrin that has anti-inflammatory, antioxidant, and antitumor properties, is being developed as a potential therapeutic for high-grade glioma (HGG) and head and neck (H&N) cancer. An IND has been opened for BMX-001 in the treatment of HGG (NCT02655601) and another is in preparation for H&N. The safety of BMX-001 has been evaluated in a battery of nonclinical Good Laboratory Practice (GLP)-compliant studies. Systemic toxicity has been evaluated using the intended cGMP product administered subcutaneously for periods of up to 5 weeks in both the mouse and the monkey and included toxicokinetic e...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Gad, S. C., Sullivan, D. W., Spasojevic, I., Mujer, C. V., Spainhour, C. B., Crapo, J. D. Tags: Regular Articles: Nanomaterials and Nanotoxicology Source Type: research

In Vitro Toxicological Assessment of Magnesium Oxide Nanoparticle Exposure in Several Mammalian Cell Types
In this study, the toxic potentials of MgO nanoparticles were investigated on liver (HepG2), kidney (NRK-52E), intestine (Caco-2), and lung (A549) cell lines. For the toxicological assessment, the following assays were used: the particle characterization by transmission electron microscopy, the determination of cellular uptake by inductively coupled plasma-mass spectrometry, MTT and neutral red uptake assays for cytotoxicity, comet assay for genotoxicity, and the determination of malondialdehyde (MDA), 8-hydroxydeoxyguanosine, protein carbonyl, and glutathione levels by enzyme-linked immune sorbent assays for the potential...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Mahmoud, A., Ezgi, O., Merve, A., Özhan, G. Tags: Regular Articles: Nanomaterials and Nanotoxicology Source Type: research

Teratogenicity of Artemether-Clindamycin Nanostructured Lipid Carriers in Rats
Currently, artemisinin-based combination therapy is considered the best option in the treatment of malaria. However, toxicity of artemisinins limits their use in pregnancy. In the absence of sufficient toxicity data, the World Health Organization recommends that artemisinins are not to be used in the first trimester of pregnancy and can be used only in second and third trimesters, when other treatments are not available. We have recently observed that drugs loaded in nanolipid carriers are selectively taken up in Plasmodium-infected erythrocytes with a concomitant reduction in the dose required to cure animals. Thus, 20% o...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Jain, S. A., Awale, M., Pathak, S., Vanage, G., Patravale, V. B., Sharma, S. Tags: Regular Articles: Nanomaterials and Nanotoxicology Source Type: research

Toxicologic Pathology Analysis for Translational Neuroscience: Improving Human Risk Assessment Using Optimized Animal Data
A half-day American College of Toxicology continuing education course presented key issues often confronted by translational neuroscientists when predicting human risk from animal-derived toxicologic pathology data. Two talks correlated discrete structures with major functions in brains of rodents and nonrodents. The third lecture provided practical advice to obtain highly homologous rodent brain sections for quantitative morphometry in developmental neurotoxicity testing. The last presentation discussed demographic influences (eg, species, strain, sex, age), physiological attributes (eg, body composition, brain vascularit...
Source: International Journal of Toxicology - July 4, 2016 Category: Toxicology Authors: Sharma, A. K., Morrison, J. P., Rao, D. B., Pardo, I. D., Garman, R. H., Bolon, B. Tags: ACT Annual Meeting Session Overview Articles Source Type: research