Métodos in vitro

A test performed in vitro ("in the glass") means that it is done outside of a living organism and it usually involves isolated tissues, organs or cells.

You can use in vitro data to fully or partly fulfil information requirements that would otherwise need data to be generated with tests on living organisms (in vivo tests).

In vitro methods are divided to those that meet internationally agreed validation criteria and to those that do not. For your REACH registration, preferably use methods that are sufficiently well-developed according to internationally agreed test development criteria (e.g. the European Centre for the Validation of Alternative Methods (ECVAM) pre-validation criteria).

The changes to the REACH Annexes VII and VIII in 2016 make in vitro test methods the default for certain toxicological properties.

Even if you have used an in vitro method that has not been internationally validated, you still need to submit your study results in your registration dossier as part of gathering all available information. You may also use them in a weight of evidence approach or to support the grouping of your substances.

Consejos

  • Presente una descripción clara y detallada de los resultados, de las condiciones del ensayo y de la interpretación de los resultados. Es importante si el estudio se utiliza como estudio clave o como parte de un enfoque de ponderación de pruebas.
  • Comunique claramente las limitaciones del método.
  • Utilice (preferiblemente) un método validado. Asegúrese de que los resultados sean adecuados para la clasificación y etiquetado y para la evaluación de riesgos, y de que proporciona una documentación adecuada y fiable.
  • Su método in vitro debe proporcionar información fiable comparable a la del ensayo estándar. Si no, es posible que deba realizar ensayos in vivo.

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