Toxicology is the study of the adverse effects of chemical, physical or biological agents on living organisms and the ecosystem, including the prevention and amelioration of such adverse effects. The concept of dose is a basic principle in toxicology. Paracelsus, "the father" of toxicology said, "Alle Dinge sind Gift und nichts ist ohne Gift; allein die Dosis macht, dass ein Ding kein Gift ist." which translates as, "All things are poison and nothing is without poison; only the dose makes a thing not a poison". Dose is the amount of chemical that comes into contact with the body or gets inside the body. The phrase, ‘dose makes the poison’ does capture a fundamental principle of toxicology, but the actual study of toxicology is much more nuanced and complex. The potency of a chemical, or how toxic it is, depends upon its movement through the body to the target site (toxicokinetics); its ability to interact with the body to cause harm (toxicodynamics); and the dose the body receives (exposure level), which is in turn modified by the toxicokinetics and toxicodynamics of the chemical.

It has been known for more than a century that exposure to particular chemicals and complex mixtures can lead to the development of cancer in later life. The pathogenesis of cancer has primarily been demonstrated to be due to damage to DNA although non-genotoxic mechanism has also been demonstrated to cause cancer (Bolt et al, 2004). Cancer causing agents, known as carcinogens will be able to directly cause DNA damage or requires metabolic activation to an active metabolite which can interact with DNA (Fig. 1). If the DNA damaged cell is not repaired, it may be replicated and passed on to daughter cells as a result of cell proliferation leading to growth advantage and genetic instability. DNA repair is therefore a very important aspect in recovering the damage and in certain cases, the DNA damaged cell can undergo cell death via apoptosis, therefore heritable mutation can be avoided.

In the past decade, increasing efforts have been demonstrated to decrease the use of animals in safety testing (Kirkland et al., 2005). Therefore in vitro methods are gaining wider acceptance and play a crucial role as alternatives or supplements to in vivo methods in safety assessment. In the framework of non-clinical safety and environmental safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products veterinary drug products, foods and feed additives, and industrial chemicals. Principle of Good Laboratory Practice (GLP) is applied and crucial for the purpose of registering or licensing these products (OECD, 2004). OECD Principles of GLP is essentially a quality system relating to the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, recorded, achieved and reported. Some of these products are biological origin and synthetic products but the aim is to obtain data on human health and/or environment safety. In line with the Malaysia Ninth Plan 2006-2010, establishment of GLP laboratories in the country is important as this will boost the pre-clinical testing activities from local sources as well as multi-national companies (9th Malaysia Plan Document).

Therefore on early 2007, Melaka Institute of Biotechnology (M.I.B.) had had proposed to setup a laboratory having the facility on mutagenicity studies which will be subjected to the National GLP Compliance Monitoring authority. On December 2007, Toxicology Unit in M.I.B. had been granted a grant by Ministry of Science, Technology and Innovation to establish a mutagenicity testing facility in accordance to OECD GLP principle. Regardless of the regulatory bodies, the mutagenicity and genotoxicity test battery will be performed according to the Organisation for Economic Cooperation and Development (OECD) globally accepted methods. The methods are:

• Gene mutation test in bacteria (OECD 471, Ames Test)

• Clastogenicity test in mammalian cells ( OECD 473, chromosomal aberration assay)

• Gene mutation in mammalian cells (OECD 476, the mouse lymphoma assay)

• Sister Chromatid Exchange (OECD 479)

Beside these methods above, Toxicology Laboratory also provide cytotoxic screening test (MTT) and Comet Assay (genotoxicity test). As mentioned above, the toxicology profile or safety data of pharmaceutical products, pesticide products, cosmetic products veterinary drug products, foods and feed additives, and industrial chemicals is required for registering or licensing these products. We are meant here to provide services for our customer to meet this requirement. As we are going to be a complied OECD GLP laboratory, our customer can also use the data provided from our laboratory to register and market their product to other OECD countries like United State of America, United Kingdom, Australia, Switzerland and many more (www.oecd.org/countrieslist).