W1 AM Nuts and Bolts of Logistics and Data Management for Data-Intensive Programs
Wednesday, 16 November 2005: 8:00 AM - 11:40 AM in Ballroom 1

(FIS-1118-239421) Practicalities of building HPV Categories for real data sets.

Fisk, Peter¹, Girling, Andrew¹, Wildey, Rosalind¹, ¹ Peter Fisk Associates, Whitstable, Kent, UK

ABSTRACT- The use of a Category to allow data for HPV substances to be presented as a group rather than on a substance-by-substance basis has a number of advantages for all stakeholders. The OECD has issued extensive guidance on this principle and how it can work. This paper will briefly review the OECD approach. It will then illustrate the techniques involved using real examples of categories that have been developed under the ICCA HPV programme. Some important principles underlying the development of categories will be discussed including: 1 Assessing the justification for treatment as a Category. 2 When sub-Categories are needed. 3 How to deal with data gaps. 4 How to deal with data of varying reliability. 5 Understanding the chemistry. 6 Finding approaches that work for both environmental and human health end points. 7 Formats of presentation. 8 Making good use of the scientific literature. In addition specific technical aspects related to the development of categories will be covered including the need to a) understand behavioural properties of members of the substance group. These properties include speciation, acid-base behaviour and salt formation; b) consider biodegradability, and acute and chronic aquatic toxicity for the members of a substance category that includes essentially single chemical species and complex, multi-component, reaction products; c) validate QSARs that are used to obtain property data for substances within a category (rather than using off-the-shelf methods). Issues relevant to the treatment of categories, within an overall assessment of HPV properties, will be highlighted.

Key words: HPV, QSAR, Category, ICCA