Division 1.4 In vitro methodsX1

Results obtained from suitable in vitro methods may indicate the presence of a certain 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 F1 ... for the entry of a test into the prevalidation F2process . Depending on the potential risk, immediate confirmation requiring testing beyond the information foreseen in Annexes VII or VIII or proposed confirmation requiring testing beyond the information foreseen in Annexes IX or X for the respective tonnage level may be necessary.

If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result, unless testing is not required in accordance with Annexes VII to X or the other rules in this Annex.

F3Such confirmation may be waived if the following conditions are met:

1. (1)

   results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

2. (2)

   results are adequate for the purpose of classification and labelling and/or risk assessment; and

3. (3)

   adequate and reliable documentation of the applied method is provided.

When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.