The Galileo Data Bank on Toxicity Testing with In Vitro Alternative Methods. I. General Structure

1994 ◽  
Vol 22 (1) ◽  
pp. 20-30
Author(s):  
Nicola Loprieno ◽  
Guido Boncristiani ◽  
Elena Bosco ◽  
Maria Nieri ◽  
Gregorio Loprieno

Toxicity testing of chemicals by means of in vitro alternative methods to the use of animals has been extensively developed, as documented by a variety of studies. The interpretation of results and the comparative evaluation of data derived from various cell toxicity studies require organisation by a computerised data system, capable of handling the large number of variables included in different assays, such as cell lines, methods of treatment with the chemical, methods used to evaluate the biological effect, endpoints considered, etc. The Galileo Data Bank has been developed by the Laboratory of Genetic Toxicology at the University of Pisa, as a scientific instrument to be used in the analysis and organisation of results obtained in the toxicity testing of chemicals by means of in vitro alternative methods.

2007 ◽  
Vol 35 (5) ◽  
pp. 531-537
Author(s):  
Michael Balls

The career of Richard Clothier is reviewed in the light of his long-standing collaboration with Michael Balls and Laurens Ruben at the University of East Anglia (UEA), the University of Nottingham, and Reed College, Portland, Oregon, USA. It began with work at UEA on the aetiology of the lymphosarcoma of Xenopus laevis, followed by studies on the effects of exposure to N-nitroso- N-methylurea on T-cell functions, which led to many contributions to comparative immunology. This was followed by the establishment of the FRAME Research Programme, which led to participation in extensive studies on the development of in vitro cytotoxicity tests and their application in acute and topical toxicity testing. A FRAME Trustee since 1983, Richard Clothier was a co-founder, and subsequently Director, of the FRAME Alternatives Laboratory in the University of Nottingham Medical School, where he led successful collaborations with a number of industrial partners and, in particular, with the European Centre for the Validation of Alternative Methods (ECVAM).


1994 ◽  
Vol 22 (2) ◽  
pp. 82-114
Author(s):  
Nicola Loprieno ◽  
Guido Boncristiani ◽  
Elena Bosco ◽  
Maria Nieri ◽  
Gregorio Loprieno

The identification of the hazard of chemicals to man has relied on the use of several animal models. However, the availability of various cell toxicity models as alternatives to the use of animals has stimulated attempts to evaluate in vitro data for use in the prediction of human toxicity. The cell toxicity models developed previously are capable of indicating a variety of endpoints susceptible to the activity of various chemical substances. The in vitro data derived so far from testing a variety of types of chemicals, have been used to develop toxicology profiles for twenty chemicals, which are presented in this paper. Data have been selected from among those already entered in the Galileo Data Bank, a computerised data system containing all the available existing data derived using in vitro methods.


1990 ◽  
Vol 18 (1_part_1) ◽  
pp. 103-116
Author(s):  
Sven Hellberg ◽  
Lennart Eriksson ◽  
Jörgen Jonsson ◽  
Fredrik Lindgren ◽  
Michael Sjöström ◽  
...  

Estimating the toxicity to humans of chemicals by testing on human subjects is not considered to be ethically acceptable, and toxicity testing on laboratory animals is also questionable. Therefore, there is a need for alternative methods that will give estimates of various aspects of human toxicity. Batteries of in vitro tests, together with physicochemical and toxicokinetic data, analysed by efficient data analytical methods, may enable analogy models to be constructed that can predict human toxicity. It may be possible to model non-specific toxicity relating to lipophilicity, or basal cytotoxicity, for a series of diverse compounds with large variation in chemical structure and physicochemical properties. However, local models for a series of similar compounds are generally expected to be more accurate, as well as being capable of modelling more-specific interactions. Analogy models for the prediction of human toxicity are discussed and exemplified with physicochemical and cytotoxicity data from the first ten chemicals in the multicenter evaluation of in vitro cytotoxicity (MEIC) project.


2008 ◽  
Vol 36 (1_suppl) ◽  
pp. 29-42 ◽  
Author(s):  
Christina Grindon ◽  
Robert Combes ◽  
Mark T.D. Cronin ◽  
David W. Roberts ◽  
John F. Garrod

Liverpool John Moores University and FRAME recently conducted a research project sponsored by Defra on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for safety testing and risk assessment of chemicals. The project covered all the main toxicity endpoints associated with the REACH system. This paper focuses on the prospects for using alternative methods (both in vitro and in silico) for environmental (aquatic) toxicity testing. The manuscript reviews tests based on fish cells and cell lines, fish embryos, lower organisms, and the many expert systems and QSARs for aquatic toxicity testing. Ways in which reduction and refinement measures can be used are also discussed, including the Upper Threshold Concentration — Step Down (UTC) approach, which has recently been retrospectively validated by ECVAM and subsequently endorsed by the ECVAM Scientific Advisory Committee (ESAC). It is hoped that the application of this approach could reduce the number of fish used in acute toxicity studies by around 65–70%. Decision-tree style integrated testing strategies are also proposed for acute aquatic toxicity and chronic toxicity (including bioaccumulation), followed by a number of recommendations for the future facilitation of aquatic toxicity testing with respect to environmental risk assessment.


1997 ◽  
Vol 36 (2-3) ◽  
pp. 91-100
Author(s):  
C. Malliaros ◽  
A. Guitonas

In the departments of Attika and Viotia there are about 1,100 industries. The total amount of produced waste from the above mentioned branches is 20 × 106 t/year, 600,000t of which contain toxic substances. By contract from October 1st, 1992 between the Ministry of the Environment, Regional Planning and Public Works and three collaborating offices (among them the office of C. Malliaros) has been assigned to the latter, the realisation of a study of the management of toxic waste (liquid) and sludges, in the Departments of Attika and Viotia. The study presented in this paper investigates the following: - collection and evaluation of data and estimation of the hydraulic and pollution loads - classification of industries according to sewage facilities - further possibilities for changes of improvements in the production process of the industrial branches for the reduction of pollution and representation of these industries on maps - proposals for the collection and transport of the liquid toxic waste and sludges - pre-treatment at the source and disposal of the liquid waste and sludges - presentation of administrative and legislative regulations - forming a policy for the management and monitoring of this waste - technical and financial evaluation and investigation of the alternative methods of treatment - suggestions for the development of the area concerning the activities and the expenses at various levels.


1993 ◽  
Vol 12 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Michael S. Dickens ◽  
Oliver Flint ◽  
Stephen D. Gettings ◽  
Richard N. Hill ◽  
Robert L. Lipnick ◽  
...  

In toxicology the development and application of in vitro alternatives to reduce or replace animal testing, or to lessen the distress and discomfort of laboratory animals, is a rapidly developing trend. However, at present there is no formal administrative process to organize, coordinate, or evaluate these activities. A framework capable of fostering the validation of new methods is essential for the effective transfer of new technology from the research laboratory to practical use. This committee has identified four essential validation resources: chemical bank(s), cell and tissue banks, a data bank, and reference laboratories. We recommend the creation of a Scientific Advisory Board of experts in toxicity testing, representing the academic, industrial and regulatory communities. Test validation acceptance is contingent upon broad buy-in by disparate groups in the scientific community: academia, industry and government. We believe that this can be achieved by early and frequent communication among the parties and agreement upon common goals. The committee hopes that the creation of a validation infrastructure built with the elements described in this report will facilitate scientific acceptance and utilization of alternative methodologies and speed implementation of reduction, refinement and replacement alternatives in toxicity testing.


2014 ◽  
Vol 50 (1) ◽  
pp. 55-62 ◽  
Author(s):  
Gabrielle Luck de Araújo ◽  
Maria Augusta Amaral Campos ◽  
Maria Anete Santana Valente ◽  
Sarah Cristina Teixeira Silva ◽  
Flávia Dayrell França ◽  
...  

Alternative methods are being developed to reduce, refine, and replace (3Rs) animals used in experiments, aimed at protecting animal welfare. The present study reports alternative tests which are based on the principles of the 3Rs and the efforts made to validate these tests. In Europe, several methodologies have already been implemented, such as tests of irritability, cell viability, and phototoxicity as well as in vitro mathematical models together with the use of in silico tools. This is a complex process that spans from development to regulatory approval and subsequent adoption by various official entities. Within this regulatory framework is REACH, the European Community Regulation for chemicals and their safe use. In Brazil, the BraCVAM (Brazilian Center for the Validation of Alternative Methods) was recently established to validate alternative methods and stimulate incorporation of new methodologies. A new vision of toxicology is emerging for the 21st century (Tox-21), and the subsequent changes are shaping a new paradigm.


1989 ◽  
Vol 16 (4) ◽  
pp. 332-343
Author(s):  
Maxine Warren ◽  
Karen Atkinson ◽  
Sarah Steer

ERGATT and FRAME have established INVITTOX, a unique data bank on the use of in vitro techniques in toxicology and toxicity testing. The principal aim of INVITTOX is to provide state-of-the-art, in-depth technical information on the performance and application of in vitro methods, gained directly from scientists working in this field. Information will also be recorded on the history of the development of each method and on its current status with regard to interlaboratory validation, independent evaluation, and recognised acceptability for use in toxicology and toxicity testing. Enquiries should be directed to INVITTOX, 34 Stoney Street, Nottingham NG1 1NB, UK (Tel: 0602 584740; Fax: 0602 503570).


2008 ◽  
Vol 36 (1) ◽  
pp. 65-80 ◽  
Author(s):  
Christina Grindon ◽  
Robert Combes ◽  
Mark T.D. Cronin ◽  
David W. Roberts ◽  
John F. Garrod

Liverpool John Moores University and FRAME conducted a research project, sponsored by Defra, on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The project covered all the main toxicity endpoints associated with the REACH system. This paper focuses on the prospects for the use of alternative methods (both in vitro and in silico) in developmental and reproductive toxicity testing. It considers many tests based on primary cells and cell lines, and the available expert systems and QSARs for developmental and reproductive toxicity, and also covers tests for endocrine disruption. Ways in which reduction and refinement measures can be used are also discussed, particularly the use of an enhanced one-generation reproductive study, which could potentially replace the two-generation study, and therefore considerably reduce the number of animals required in reproductive toxicity. Decision-tree style integrated testing strategies are also proposed for developmental and reproductive toxicity and for endocrine disruption, followed by a number of recommendations for the future facilitation of developmental and reproductive toxicity testing, with respect to human risk assessment.


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