Guideline No. 497: Defined Approaches on Skin Sensitisation
A Defined Approach (DA) consists of a selection of information sources (e.g in silico
predictions, in chemico, in vitro data) used in a specific combination, and resulting
data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical,
rule-based model). DAs use methods in combination and are intended to overcome some
limitations of the individual, stand-alone methods. The first three DAs included in
this Guideline use combinations of OECD validated in chemico and in vitro test data,
in some cases along with in silico information, to come to a rules-based conclusion
on potential dermal sensitisation hazard. The DAs included in this Guideline have
shown to either provide the same level of information or be more informative than
the murine Local Lymph Node Assay (LLNA; OECD TG 429) for hazard identification (i.e.
sensitiser versus non-sensitiser). In addition, two of the DAs provide information
for sensitisation potency categorisation that is equivalent to the potency categorisation
information provided by the LLNA.
Published on June 22, 2021Also available in: French
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