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2010/1 Module Catalogue
Module Provider: Biosciences Short Name: GTXM006
Level: M Module Co-ordinator: PRICE SC Prof (Biosciences)
Number of credits: 15 Number of ECTS credits: 7.5
Module Availability
1–5 February ‘10
31 Jan – 4 Feb ‘11
Assessment Pattern
Unseen 2.5 h written examination on the Friday of the module (50%)
Home-based assignment to be submitted within ten weeks (50%)
Module Overview
Module Aims
Learning Outcomes

Learning Outcomes:


The aims of this module are that the students will be able to understand:


·         Genotoxic/non-genotoxic activity


·         models of comparative dose responses, e.g. exponential and threshold modules


·         Acute and chronic effects, high and low toxicity responses, additive and synergistic effects


·         Lesion induction related to background


·         Study design, quality control, the activity of the TWGT and the validation of test systems


·         Operations of regulatory bodies


·         Strategies of testing



On the successful completion of this module students will:


·         Be aware of the need for careful planning at all phases of an in vivo toxicology study


·         Be able to constructively criticise experimental design


·         Be able to reduce the number of studies whose poor planning means that no useful results are obtained, and hence reduce the number of animals required.


·         Review data sets in light of current regulations


·         Evaluate the designs of studies and debate their significance in light of the 3R’s-Reduction,  Refinement and Replacement


Module Content

Module content:



·         Genotoxic and non-genotoxic activity. Direct and indirect mechanisms


·         DNA and non-DNA targets.


·         Criteria for the definition of positive, statistical significance fold increases, relationships to historical databases of control and treated values


·         Assay reproducibility. False positives and negatives.


·         Dose response relationships, exponential and threshold models, factors which may include a threshold, nucleoside analogues, aneugens, topoisomerase inhibitors, detoxification, repair etc.


·         Influence of toxicity, acute and chronic toxicity, high and low toxicities.


·         The development of optimal designs. Quality control, the activity of IWGT and the criteria for test system validation.


·         Operation of regulatory bodies


·         Strategies for testing as illustrated by national and international requirements.


·         Examples of data, with interpretation problems. Clear, equivocal and inconclusive data sets, single and multiple assays


·         Test batteries and the problems of conflicting data, weight of evidence considerations.


·         Potency measurements using in vitro and in vivo tests, potential for human risk estimation.


·         Artefacts in the in vitro and in vivo assays. False positive and negative.


·         Biological relevance of responses in vitro and in vivo, influence of species specific metabolism, S9 modifications


·         Interactive workshops evaluating test data.


Methods of Teaching/Learning
Selected Texts/Journals

Pre-course Reading :


·         Friedberg E.C., Walker , G.C., Siede, W., et al (2006) DNA Repair and Mutagenesis, 2nd edn, pub: ASM Press (ISBN 1-55581-319-4) [core reading for all modules of the MTP]


·         A number of relevant papers will be selected from the Mutation Research journal.


Last Updated
February 2010