Source: EURLEX
Language: en
Format: md

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# 92001E3471

**WRITTEN QUESTION E-3471/01 by Cristiana Muscardini (UEN) to the Commission. Alternative methods of evaluating acute toxicity.** 
  
*Official Journal 160 E , 04/07/2002 P. 0120 - 0121*

  

WRITTEN QUESTION E-3471/01

by Cristiana Muscardini (UEN) to the Commission

(4 January 2002)

Subject: Alternative methods of evaluating acute toxicity

The MEIC (Multicenter Evaluation of In Vitro Cytotoxicity) research programme has examined over sixty of the most promising alternative methods of evaluating the acute toxicity of chemical substances and has compared the data obtained from human exposure, by animal testing and by means of alternative methods.

The results appear to demonstrate that a series of three human cell tests can provide a more accurate assessment of the acute toxicity of chemical substances and, consequently, a safer and faster means of protecting public health, than the corresponding animal tests currently practised.

This being so:

1. Is the European Centre for the Validation of Alternative Methods aware of this series of studies?

2. Has the study and validation procedure required for official recognition of the relevant alternative methods begun, or is it due to begin?

3. If not, what does the Commission intend to do to ensure that awareness of these new methods does not continue to be restricted to a few groups of specialists?

Answer given by Mr Busquin on behalf of the Commission

(14 February 2002)

The European Centre for the validation of alternative methods (ECVAM) is fully aware of the Multi-center evaluation of in vitro cytotoxicity (MEIC) research programme. The Head of ECVAM laboratory Unit participated in the programme.

ECVAM was also involved in the international workshop on in vitro methods for assessing acute systemic toxicity, organised by the United States Interagency Co-ordinating Committee on the validation of alternative methods (ICCVAM), and held in Arlington, Virginia, United States, on 16-20 October 2000. The MEIC programme was one of the main focuses of attention at this workshop.

One of the main recommendations of the ICCVAM workshop was that there should be a validation study on the use of in vitro cytotoxicity assays for predicting rodent oral lethal doses and human lethal concentrations, since the MEIC programme was not designed to represent a formal validation study conducted according to currently-accepted international criteria.

This study is now being planned as an ICCVAM/ECVAM collaborative project, which will involve the testing of 60 coded chemicals in two assays, in three or four laboratories in the United States and in Europe. It is expected that the results will be available by the end of 2002.

In vitro methods for predicting basal cytotoxicity have been widely used in many parts of the world for several years, and have already contributed to a reduction in the need for animal experimentation. However, the purpose of the ICCVAM/ECVAM study is to provide independent advice on their formal use for regulatory purposes, initially to predict starting doses for mandatory in vivo testing, in order to reduce animal suffering and to reduce the number of animals required. The longer term aim is to do away with the use of animals.

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