Testing for chemical health and safety

S. Nunns, Principles for Proof Testing of Safety Instrumented Systems in the Chemical Industry, Prepared by ABB Ltd. for the Health and Safety Executive Contract research report 428/2002, 2002, http //www.hse.gov.uk/research/crr pdf/2002/crt02428.pdf. 

All the PMBs are Hsted on the U.S. EPA s Toxic Substances Control Act NonConfidential Chemical Substances Inventory (Table 8). In the early to mid-1980s, pseudocumene, mesitylene, hemimellitene, and trimethylbenzene were coveted by TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) reporting requirements (22) and by TSCA Section 8(d) for health and safety data (23). Mesitylene is the subject of a test rule subacute oral toxicity and subchtonic oral toxicity in tats were underway in 1994 (24). The Safe Drinking Water Act (SDWA) allows monitoring for pseudocumene and mesitylene at the discretion of the State (25). Of the PMBs, only pseudocumene is subject to SARA Tide III section 313 annual release reporting (26). 

A complete analysis of dense gas dispersion is much beyond the scope of this treatise. More detailed references are available (Britter and McQuaid, Workbook on the Dispersion of Dense Gases, Health and Safety Executive Report No. 17/1988, England, 1988 Lees, 1986, pp. 455 61 Hanna and Drivas, 1987 Workbook of Test Cases for Vapor Cloud Source Dispersion Models, AlChE, 1989 Guidelines for Chemical Process Quantitative Risk Analysis, 1989, pp. 96-103). 

TSCATS is an online index to unpublished, nonconfidential studies covering chemical testing results and adverse effects of chemicals on health and ecological systems. The studies are submitted by US industry to EPA under several sections of the Toxic Substance Control Act (TSCA). There are four types of documents in the database Section 4 chemical testing results, Section 8(d) health and safety studies, Section 8(e) substantial risk of injury to health or the environment notices, and voluntary documents submitted to EPA known as a For Your Information (FYI) notice. 

Established in 1894, AOAC International is an independent association of scientists and organizations in the public and private sectors devoted to promoting methods validation and quality measurements in the analytical sciences. AOAC has a mission to ensure the development, testing, validation, and publication of reliable chemical and biological methods of analysis for foods, drugs, feed-stuffs, fertilizers, pesticides, water, forensic materials and other substances affecting public health and safety and the environment. 

There are two aspects of this program that will effect the research and development investment decision. First, the costs of premanufacture notification (including testing costs) will increase the investment in R D necessary to develop and market new chemicals. The health and safety properties of a chemical must now be considered an intrinsic part of the new chemical development process, right alongside consideration of the substances commercial properties. Both are equal parts of the "total product". Tb the extent that this results in increased testing for health and environmental effects, the amount of investment required to achieve a given level of output from R D will also rise. 

Both these factors - increased testing and additional uncertainty, will reduce the output of research and development in the chemical industry (if measured by numbers of new chemicals marketed) that would likely be achieved in their absence. It is an undeniable fact that the market for some low volume, specialty chemicals will not be sufficient to justify the expenditure necessary to perform adequate health and safety testing. It would be foolish of me to stand before you and deny this. 

Acute dermal toxicity is the study of adverse effects occurring within a short time of dermal application of a single-dose test chemical. In evaluating the safety of a chemical, determination of acute dermal toxicity is useful when exposure by the dermal route is likely and more predominant. It provides information on health hazards likely to arise from short-term exposure by the dermal route. Data from an acute dermal toxicity study may serve as a basis for chemical classification and labeling. It is an initial step in establishing a dose regimen in subchronic (and other) studies, and may provide information on dermal absorption as well as a chemical s mode of toxic action. 

Characterizing the hazards of new chemical entities is as much of an art as it is a science. As they are new, there is usually no information available on the specific compound, and it can be several months to years after the discovery of the new chemical entity before it can be well-characterized from a health and safety perspective. This is due to a number of reasons. First, enough of the compound needs to be synthesized so that there is a sufficient quantity available for testing and analysis. As the yields early on are quite small, it may take several syntheses before there is sufficient material for testing. Secondly, complete hazard characterization is expensive it is cost prohibitive to conduct extensive testing on every newly discovered compound. In addition, a vast percentage of new compounds will never become approved drugs. 

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