Division Circumstances in which required

The skin sensitisation test shall be carried out unless the active substances or co-formulants are known to have sensitising properties or the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, skin sensitisation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the sensitising potential of the total mixture.

The local lymph node assay (LLNA) shall be used, including where appropriate the reduced variant of the assay. In case the LLNA cannot be conducted, a justification shall be provided and the Guinea Pig Maximisation Test shall be performed. Where a guinea pig assay (Maximisation or Buehler), meeting OECD guidelines and providing a clear result, is available, further testing shall not be carried out for animal welfare reasons.

Since a skin sensitiser can potentially induce hypersensitivity reaction, potential respiratory sensitisation shall be taken into account when appropriate tests are available or when there are indications of respiratory sensitisation effects.