Toxicity. Aim: To evaluate the overall toxicity of AE37 peptide vaccine in combination with pembrolizumab Endpoint: Frequency and severity of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
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 (Xx, S. et al., 1998, Lv, X.X. xx 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 (Xx, X. 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, Xx 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. 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. There is evidence based on the RAC opinion2 on UV-320 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 Xxxxx XXXX is fulfilled.
Toxicity. 11. The FSA and HSE will maintain regular contact with each other on generic and substance specific issues relating to regulatory toxicology. In addition the HSE will continue to have access to the Committee on Toxicity, for which the FSA provides the Secretariat, to seek opinions on toxicological issues relating to occupational exposure. Risk Analysis
Toxicity. For each chemical constituent listed in requirement #1, the Application must include all available data on acute and chronic toxicity (such as mutagenicity, teratogenicity and carcinogenicity) and phytoxicity, as those factors potentially impact: ◆ human health upon ingestion, respiration and dermal contact; ◆ representative species of aquatic, amphibian, and terrestrial animals; and ◆ representative species of vegetation. Toxicity tests must be conducted by standard methods referred by USEPA (U.S. Environmental Protection Agency) or ASTM (American Society for Testing and Materials) - preferably the latest methods. The “flow-through” methods must be used unless it is shown that “static” methods are adequate (i.e., low toxicity and high concentration; low volatility; high persistence). Examples of acceptable testing procedures are:
Toxicity. The mussel embryo development test (EPA/600/R-95/136) will be used to assess the toxicity of the surface water samples. Toxicity Identification Evaluation (TIE) will be used to characterize the cause(s) of toxicity, where appropriate, using EPA/600/R- 96/054. Table 8. (Element 13). Analytical methods. NA = not applicable. Analyte Method Modifications to Method Method Detection Limit Chemistry Cu (dissolved) EPA 1638 None 0.01 µg/L Toxicity Mussel development test EPA/600/R-95/136 EPA/600/R-96/054 (TIE) None NA
Toxicity. Based on the available ecotoxicity and mammalian data, Dechlorane Plus does not currently meet the T criterion. Long-term toxicity studies using relevant life stages of fish (via diet), sediment or soil organisms, and/or birds could be performed to clarify whether adverse effects can occur via these exposure routes. However, as the substance meets both the vP and vB criteria, these are not scientifically necessary for environmental risk management purposes.