Академический Документы
Профессиональный Документы
Культура Документы
number of toxicology procedures for Cosmetics and Toiletries Total number of acute lethal tests in the rat (LD50/LC50)
0 2292
The vast majority of animals used in the European Union are used in:
Fundamental biological research Applied research in human medicine and dentistry Applied research in veterinary medicine Breeding programmes, especially for genetically modified animals
For all industry sectors (pharmaceuticals, agrochemicals, industrial chemicals, cosmetics, household products)
Regulatory requirements for conducting clinical trials, registration, safe manufacture, transport Assess hazard not risk Wide range of complex hazard endpoints (acute, chronic, reproductive system, cancer, teratogens, sensitisers) New endpoints / tests (nervous system, immune function, susceptible human sub-populations, e.g. children)
Public and regulatory expectation for safer drugs pesticides, chemicals and food and for reduced animal use.
Toxicology offers both a threat and an opportunity for reduction, refinement and replacement alternatives to animal experimentation
Refinement / Reduction
Acute oral toxicity Skin sensitisation
INVENTION TO REGULATORY ACCEPTANCE TOOK 15 20 YEARS
In-Vitro Replacement Tests Available Only in Longer Term (more than 10 years)
Acute toxicity Skin and respiratory sensitisation Kinetics and metabolism Target organ / system toxicity Developmental and reproductive toxicity Non-genotoxic carcinogenesis
Is this pessimistic or too conservative ? Why does it take so long to develop and validate alternatives ? Would more investment in alternatives speed up progress ?
Outcome
Understanding basic toxic or biological mechanisms New methods for specific applications Optimised transferable protocol Establishment of reliability and relevance Independent scientific peer review Regulatory agency decision on acceptability for specific application
Science or Technology
Science Science
Technology Technology -
Technology can be driven to a timetable by the application of sufficient resources and management skills, while science has a pace of its own
IFH Purchase, 1996
Regulatory acceptance also has a pace of its own, and is perceived to be driven as much by politics as by science
PA Botham, 2002
The appropriate application of these techniques is more demanding of careful experimental design than ever, as the potential to generate incomplete and misleading data is great. The attainment of common ground through collaboration involving the generation, sharing and publication of suitable, high quality, data should be prime goal for scientists and institutions engaged in researching the new technology and its appropriate application towards improving the knowledge of the interaction of chemicals with living things.
B Pennie, 2001