1.4. In vitro methods

Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria. Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests. However, such confirmation may be waived if the following conditions are met: results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles; results are adequate for the purpose of classification and labelling and risk assessment; and adequate and reliable documentation of the applied method is provided. In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case-by-case basis.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.