Estado de las directrices de la OCDE sobre el cumplimiento normativo de los materiales bidimensionales: un estudio de caso del grafeno
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La evaluación regulatoria del grafeno y otros materiales bidimensionales (2D) presenta desafíos significativos debido a las propiedades fisicoquímicas únicas de estos materiales. Dado que el grafeno es el nanomaterial 2D más utilizado y uno de los más variables estructuralmente, constituye un caso de estudio crucial para evaluar la aplicabilidad de los protocolos de ensayo de la OCDE, utilizados de manera generalizada en ensayos toxicológicos. Reforzar esta conexión es particularmente importante, pues los métodos aceptados por la OCDE respaldan el cumplimiento regulatorio en marcos como el reglamento REACH de la UE y la Ley de Control de Sustancias Tóxicas de EUA, lo cual significa que las deficiencias en la idoneidad de las directrices afectan directamente la autorización de comercialización y la gestión de riesgos. Las Directrices de Ensayo (Test Guidelines (TG), por sus siglas en inglés) y los Documentos de Orientación (Guidance (GD), por sus siglas en inglés) de la OCDE existentes se desarrollaron principalmente para productos químicos convencionales y, a menudo, no abordan adecuadamente las especificidades de los materiales 2D. Estas se deben a sus estructuras atómicamente delgadas y estratificadas, y a su confinamiento cuántico en una sola dimensión. Este artículo ofrece una visión general crítica del estado actual de la aplicabilidad de las directrices de la OCDE para el grafeno y propone futuras direcciones para armonizar los enfoques de las pruebas regulatorias con el fin de garantizar la seguridad y el cumplimiento.
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Mundo Nano. Revista Interdisciplinaria en Nanociencias y Nanotecnología, editada por la Universidad Nacional Autónoma de México, se distribuye bajo una Licencia Creative Commons Atribución-NoComercial 4.0 Internacional.
Basada en una obra en http://www.mundonano.unam.mx.
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