EXPAREL (bupivacaine extended-release liposome injection), DepoFoam bupivacaine, is in development for prolonged postsurgical analgesia. Repeat-dose toxicity studies were conducted in rabbits and dogs to compare the potential local and systemic toxicities of EXPAREL and bupivacaine HCl (Bsol), and the reversibility of any effects. Dogs tolerated much larger doses than rabbits. EXPAREL-related m...

The aim of this study was to evaluate the toxicology safety of a genetically modified (GM) Bacillus thuringiensis with vegetative insecticidal protein (VIP) gene. Acute and subacute toxicity studies by using its powder preparation were conducted in Wistar rats. The result of the acute study showed the no-observable-adverse-effect level (NOAEL) of this GM B. thuringiensis powder preparation was ...

Timed-pregnant Sprague-Dawley (CD) outbred rats and New Zealand White rabbits were dosed by gavage with methacrylonitrile (MACR) in distilled water during major organogenesis. Rats were dosed on Gestational Days (GD) 6 through 15 (0, 5, 25, or 50 mg MACR/kg/day) and rabbits on GD 6 through 19 (0, 1, 3, or 5 mg MACR/kg/day). Maternal clinical status was monitored daily during treatment. At termi...

This paper evaluates procedures relevant to extrapolating from toxicity data in man and animals to Occupational Exposure Limits. It examines effects at or around the "No Observed Adverse Effect Level' (NOAEL) and the magnitude of safety factors which can be applied in developing occupational exposure limits for non-stochastic effects. The relationship between incidence of stochastic effect and ...

Bisphenol A (BPA) is a high production volume industrial chemical to which there is widespread human oral exposure. Guideline studies used to set regulatory limits detected adverse effects only at doses well above human exposures and established a no-observed-adverse-effect level (NOAEL) of 5 mg/kg body weight (bw)/day. However, many reported animal studies link BPA to potentially adverse effec...

Tributyl phosphate (TBP) was tested for reproductive toxicity in rats. Thirty weanlings/sex (F0) were exposed to TBP in the diet ad libitum at 0, 200, 700, or 3000 ppm for 10 weeks and then randomly mated within groups for 3 weeks with continued exposure. F0 parents and 10 F1 weanlings/sex/dose were necropsied, and adult reproductive organs, urinary bladders (both sexes), kidneys (males), and l...

2.0 Points of Departure and Potency Estimates...............................................3 2.1 The Benchmark Dose approach.................................................... 3 2.2 The T25 approach......................................................................7 2.3 Comparing BMD and T25 methodology for use in risk assessment.........8 2.4 The TD50 approach................................

The most relevant data for developing a reference dose (RfD) for perchlorate exposures comes from human epidemiology and clinical studies, supplemented with available and extensive information on experimental animals. Specifically, serum T4 decrease is the critical effect of perchlorate, based on a mode-of-action analysis and the evidence provided by the body of rodent studies on perchlorate. H...

Submit Manuscript | http://medcraveonline.com Abbreviations: LCT: Lambda-Cyhalothrin; LD: Lethal Dose; NOAEL: No-Observed-Adverse-Effect Level; Con A: Concanavalin A; SRBCs: Sheep Red Blood Cells; WBCs: White Blood Cells; Ig: Immunoglobulin; HA: Hemagglutination; QHS: Quantitative Hemolysis of SRBCs; FCS: Fetal Calf Serum; DTH: Delayed-type of Hypersensitivity Response; BMCs: Blood Mononuclear ...

Fullerene C(60) has great potential for use in many industry and medical nanotechnology applications. Although the use of nanomaterials has been increasing in the recent years, limited information about its potential hazardous effects is available. Therefore, safety of nanomaterials is a world concern. Before health effects arise in workers and the general population, development and use under ...