Creation of GSK products from earliest research & development through to full-scale manufacture requires that employees work directly with or in proximity to chemicals. While GSK is committed to safety in all aspects of its operations, circumstances arise in which workplace exposure to chemicals may occur. To safeguard worker health, GSK health and safety programmes for chemicals have been organised to define health protective occupational exposure limits and provide information on unique chemical hazards. This dual approach supports design of equipment and facilities to contain and control chemicals in the workplace. It also provides information for first aid and other care in the event of accidental contact with chemicals.

GSK occupational toxicologists in the Corporate Environment, Health and Safety group focus on understanding the potential effects of GSK drugs and the chemical building blocks for these drugs encountered in R&D and manufacturing settings. Occupational toxicologists specialise in understanding the results of possible chemical exposure on the skin, eyes, and respiratory system (common routes of workplace chemical exposure) as well as other human systems.

Historically, achieving an understanding of the effects of chemicals in the workplace has involved use of laboratory animals as models for human systems. However, growing scientific and public awareness around ethical use of laboratory animals has guided GSK efforts to continuously reduce reliance on animal models for occupational toxicology wherever possible. Use of refined test strategies for occupational toxicology testing in GSK and alignment of testing with the scale of product manufacture (i.e., only limited testing until initiation of large scale manufacture) has resulted in a 15 to 20% reduction in animal use for worker safety testing on each product brought to commercial development over the period 1999 - 2001.

In the first two years of GSK's corporate history (2001 and 2002), testing for the potential harmful effect of chemicals in the workplace has been organised to achieve continued progress toward the goals of reducing, refining and replacing laboratory animals. New published practices involve the use of a tiered approach to occupational health hazard assessment in GSK. This approach uses a variety of predictive tools including computer models and cell culture systems allowing rapid and accurate evaluation of the potential effects of chemicals on human skin, eye, and other tissues possibly subject to direct chemical contact.

In this approach, evaluation of the potential effects of chemicals is initiated with searches for all applicable information from literature databases. Structure-activity computer models are also used to predict possible effects. Initial research is complemented by evaluation of chemical parameters (such as acidic or basic character) that can contribute to possible adverse effects. In many cases, this first tier of assessment is sufficient to understand the hazards posed by chemicals making it possible to avoid use of laboratory animals altogether by projecting likely effects from previously characterised materials to new materials. When insufficient or equivocal information is available from the initial tier of assessment a second tier of testing is invoked. This second tier of testing involves use of cell culture, tissue culture and bacterial models. GSK scientists have adopted several animal-use reduction techniques recognised by health regulatory and advisory agencies (such as the UK HSE and US NIH) to organise the second tier of evaluation. GSK scientists actively develop, publicise and validate alternative methods used in the second tier to allow increased reliance on test methods not using laboratory animals. Again, results of Tier II testing exempts many materials from evaluation in animal models. Finally, only when chemical production levels reach certain high volume levels (thereby increasing the potential for inadvertent or accidental chemical exposure) are tests with laboratory animals considered. In many cases these tests are required by regulatory guidelines. Even in these cases, alternate means for identifying chemical hazards are sought, and testing is done with reduced animal numbers.

Consistent application of the tiered approach to chemical hazard assessment from 2002 forward is anticipated to minimise use of laboratory animals in chemical hazard assessments for worker health and safety purposes. In addition, GSK strongly supports continued innovation in development of alternative means for learning about the potential health effects of workplace chemicals. Success in these efforts is measured by improved predictive ability of these alternatives and continued reductions in use of laboratory animals.