Possibilità concrete per applicare i metodi senza animali per la valutazione tossicologica delle sostanze.

The term "alternative methods" is now replaced by the New Approach Methodologies (NAMs). That's because in the past we usually looked for in vitro methods that could provide the same information that was gained through in vivo methods. Today, we aim to completely change the approach with a focus on the real biological mechanisms triggered by exogenous chemical substances through complex integrated systems based on human organoids and reconstructed human tissues. Even though there is consensus in considering NAMs as the future of toxicology, their use in the regulatory context is still difficult. REACH Regulation was the first legislative act to officially include the possibility of using non-conventional approach for risk assessment of chemicals. Annex XI describes how to adapt nonstandard information to comply with the requests of the other REACH annexes that need traditional in vivo tests. In addition, within REACH the definition of skin/eye irritation and skin sensitisation should be performed with in vitro methods first. Beyond this important contribution, REACH remains a regulation demanding many new tests on vertebrate animals. A recent publication demonstrates that until now REACH has requested the use of 4.2 million animals only for the definition of the repeated dose toxicity, reproductive and developmental toxicity, in spite of the acknowledgement of the limits of the in vivo tests that are often not useful to define specific problems caused to human health by chemicals. Therefore, change of the approach in toxicology is of the utmost importance to protect the human health and the environment. [ABSTRACT FROM AUTHOR]