Abstract:
OBJECTIVE To explore the feasibility of evaluating primary skin irritation of High-density Polyethylene (HDPE) bottles for topical liquid preparation using reconstructed human epidermis model.
METHODS Six batches of HDPE bottles for topical liquid preparation were tested to predict primary skin irritation by Epikutis
® model and EpiSkin
TM model
in vitro, the datas were compared with the results of rabbit test.
RESULTS The test results suggested that the classification results from rabbit test and reconstructed human epidermis test method were all non-irritation, classification consistency of
in vitro and
in vivo was 100%.
CONCLUSION Reconstructed human epidermis models can be used to evaluate primary skin irritation potential of HDPE bottles for topical liquid preparation.