Toxicity Sample Clauses

Toxicity. Although cationic lipids are not immunogenic like viral vectors, they are not without any toxicity. They can be cytotoxic and the extent to which this is manifested differs between different reagents and cell types. The prospect of toxicity is determined by the nature of the cationic carrier as well as the cationic lipid/nucleic acid complex (Lv, H.T. et al., 2006). In terms of cationic lipid/nucleic acid complexes, the toxicity may, in part, be caused by the large size of the complexes, and the high positive zeta potential required for their uptake (▇▇, S. et al., 1998, Lv, ▇.▇. ▇▇ al., 2006). Therefore the toxicity is also associated with the charge ratio between the cationic lipid species and the nucleic acids, as well as the dose of lipoplexes administered. Higher +/-charge ratios are generally more toxic due to the high positive zeta potential as well as the presence of free (i.e., empty) liposomes (▇▇, ▇. et al., 1999). Free liposomes are present at high charge ratios when lipid is in excess to nucleic acid but their role in transfection efficiency remains unclear. However, ▇▇ et al (1999) showed that their removal did not increase transfection efficiency but did allowed prevention of a decrease in transfection-associated toxicity. Free liposomes may also compete with nucleic acid complexes for interaction with negatively charged membranes and uptake in cells.

Toxicity. Refer to the current pembrolizumab IB for toxicity information.

Toxicity. Refer to the current AE-37 vaccine IB for safety and toxicity information.

Toxicity. No additional information available *** Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 1/22/2014 EN (English) 7/9 *** Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Silica Sand Safety Data Sheet

Toxicity. During radiotherapy, any kind of side effect was reported in 26% of all irradiated patients (Table 3). Nineteen percent was grade 1 toxicity, representing only minor complaints. In 7% of the patients there was a grade 2 or 3 complication. Acute transient neurological complaints were recorded in 53 patients, of which 35 had grade 1, not requiring any intervention. In 2 patients the shielding was adjusted and the upper border was lowered in 3 patients. In 13 patients treatment was interrupted due to serious pain in the gluteal region or legs. Remarkably, of these 13 patients, 6 patients were treated in one radiation institute. No relation with number of portals, upper border, treatment position or shielding could be found. Due to the fact that the neurotoxicity score was introduced in 1997, data about neurotoxicity are missing in 178 patients. In four (<1%) patients other grade 3 toxicity was reported, leading to postponement of the operation in two patients with thrombo-embolic complications. One patient required a catheter due to urinary retention after the radiotherapy. The last patient had anal blood loss 2 months after radiotherapy and proctoscopy confirmed a proctitis. Table 3. Number of patients with radiotherapy toxicity. ▇▇▇▇ ▇▇▇▇▇▇▇ ▇ ▇ ▇ ▇ Skin 685 8 2 0 Gastrointestinal 605 75 14 1 Genitourinary 676 16 2 1 Neurological 464 35 5 13 Other 655 31 7 2 Table 4. Surgery characteristics. RT+TME TME n=695 n=719 n % n % P Operation characteristics time (median, range) 180 65-390 180 70-380 ns blood loss (median, range) 1100 50-20000 1000 20-15000 <0.001 LAR 1025 800 <0.001 APR 1200 1300 ns hospital stay (median, range) 15.0 3-179 14.0 0-169 ns Operation type when LAR planned LAR 408 85 435 89 ns APR 45 9 35 7 ▇▇▇▇▇▇▇▇ 30 6 21 4 Stoma in LAR patients no stoma 176 36 216 43 0.05 stoma 263 64 249 57 Anastomosis in LAR patients side-end 261 60 278 60 ns end-end 54 12 50 11 pouch 122 28 132 29 missing 2 5 60 53 40 47 Operation time in minutes, blood loss in ml and hospital stay in days. ns=not significant To evaluate whether preoperative radiotherapy influences operation procedures, surgery characteristics are compared in Table 4. There was no significant difference in median operation time or median hospital stay between both treatment arms. Total blood loss was slightly increased (100 ml) in the irradiated (RT+) group (P<0.001). Subset analysis revealed that the difference in median blood loss was mainly present in the LAR patients: 1025 ml in the RT+ group ...

Toxicity. There is evidence based on the RAC opinion2 on UV-328 that indicates that the substance meets the criteria for classification as STOT RE 2 as defined in the CLP Regulation (EC) 1272/2008. As a consequence, the toxicity criterion of REACH ▇▇▇▇▇ ▇▇▇▇ is fulfilled.

Toxicity. Ecology - general : Hydrogen peroxide is naturally produced by sunlight (between 0.1 and 4 ppb in air and 0.00 to 0.1 mg/L in water). Not expected to have significant environmental effects. LC50 fish 1 16.4 mg/l (Exposure time: 96 h - Species: Pimephales promelas) EC50 Daphnia 1 18 – 32 mg/l (Exposure time: 48 h - Species: Daphnia magna [Static]) LC50 fish 2 18 – 56 mg/l (Exposure time: 96 h - Species: Lepomis macrochirus [static])

Toxicity. Several data are available on human health toxicity and ecotoxicity of D6, but these were not assessed for this report. D6 contains D4 and/or D5 as impurities. D4 fulfils the PBT and vPvB criteria and D5 meets the vPvB criteria (see the MSC SVHC agreements for D4 and D5)). Taking all information into account, including the concentration of D4/D5 and the properties of these substances, D6 thereby fulfils the PBT criteria with D4 in concentration of ≥0.1 % (w/w) and the vPvB criteria with either one or both D4 and D5 in concentration of ≥0.1 % (w/w).

Toxicity. No clear relationship between posaconazole exposure and treatment-related toxicity has been identified to date [32, 87]. During the development process of the delayed-release tablet and the intravenous formulation, an upper toxicity limit of 3.75 mg/L was selected, which was derived from the 90th percentile of the exposure achieved from previous clinical studies that characterized safety for approval of the posaconazole oral suspension [32]. The most frequently reported adverse events during posaconazole treatment included gastrointestinal disorders, such as diarrhea, nausea, vomiting, and also hypokalemia, pyrexia, which are of little clinical concern and considered acceptable [2, 77, 78]. In the following sections we summarize the two posaconazole-related toxicities that are of most clinical concern, namely hepatotoxicity and cardiotoxicity.