Normal handling and use

AIO.2.3.3 As in addition the surface area of the particles in the test sample has an important influence on the rate and extent of transformation/dissolution, powders are tested at the smallest representative particle size as placed on the market, while massives are tested at a particle size representative of normal handling and use. A default diameter value of 1 mm should be used in absence of this information. For massive metals, this default may only be exceeded when sufficiently justified. The specific surface area should be determined in order to characterize and compare similar samples. 

Category 3a Substances, which are well investigated and for which a carcinogenic potential does not need to be considered in normal handling and use. 

Dangerous substances have to be labeled in accordance with Article 23 of Dangerous Substance Directive 67/548/EEC [4-1] and dangerous preparations in accordance with Article 10 of Dangerous Preparation Directive 1999/45/EC [4-3]. The intention of labehng is to inform the professional user (as well as everybody else) of the most important hazards of substances and preparations and the main precautionary measures. Therefore the label should express aU potential hazards which could be relevant to normal handling and use of the substances or preparations. 

A brief description for normal handling and use is required, and additional instructions in case of accidental releases are discussed in Chapter 6. 

A concise, complete, and comprehensible description has to be given of the various toxicological effects produced on normal handling and use, with consideration of the different possible exposure routes. 

A solution of sulfur trioxide [7446-11-9] dissolved in chlorosulfonic acid [7990-94-5] CISO H, has been used as a smoke (U.S. designation FS) but it is not a U.S. standard agent (see Chlorosulfuric acid Sulfuric acid and sulfur trioxide). When FS is atomized in air, the sulfur trioxide evaporates from the small droplets and reacts with atmospheric moisture to form sulfuric acid vapor. This vapor condenses into minute droplets that form a dense white cloud. FS produces its effect almost instantaneously upon mechanical atomization into the atmosphere, except at very low temperatures. At such temperatures, the small amount of moisture normally present in the atmosphere, requires that FS be thermally generated with the addition of steam to be effective. FS can be used as a fill for artillery and mortar shells and bombs and can be effectively dispersed from low performance aircraft spray tanks. FS is both corrosive and toxic in the presence of moisture, which imposes limitations on its storage, handling, and use. 

Traditionally, HPLC, GC-MS, or LC-MS methods were used to monitor the clearance of small-molecule impurities. These analytical techniques often require unique solvents, columns, methods, reagents, detectors, and buffers for each analyte to be quantified. The NMR method, albeit not the most sensitive technique, normally does not have these problems. In this chapter, some examples will be used to demonstrate that NMR is a fast, generic, and reliable analytical technique for solving analytical problems encountered in the development of biopharmaceutical products. The NMR techniques described here require minimal sample handling and use simple standard NMR methods. They can easily be implemented and used for process development and validation purposes. 

Tile nitroaromatic compds, such as TNT, are usually quite stable in the presence of traces of acids but not when in contact with metals. The danger from occluded acids in the case of the nitrocompds arises from the reaction of the acid with the metal container in which the expl is usually confined. The metal salts produced by the action of the acids on the metal are capable of reacting with the nitrocompds to form highly sensitive metallo-org compds, the presence of which greatly increases the hazards involved in handling and use. Some expls, such as PA, are normally acidic because of their chem structure, even when pure. In the presence of some metals, highly expl salts(such as pi crates) may form... 

Observe normal precautions appropriate to the circumstances and quantity of material handled. Acetyltriethyl citrate may be irritating to the eyes or the respiratory system as a mist or at elevated temperatures. Gloves and eye protection are recommended for normal handling and a respirator is recommended if used at elevated temperatures. 

Once a substance has been classified, the hazard(s) must be communicated to target audiences. The main tools of chemical hazard communication are labels and MSDSs (sometimes called Safety Data Sheets (SDSs) and Material Data Sheets (MDSs)) that contain the hazard information. Their purpose is to identify the hazardous properties of chemicals that may constitute a health, property, or environmental risk during normal handling or use. 

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