Successful prevalidation of the slug mucosal irritation test to assess the eye irritation potency of chemicals.
A previous 'in house' validation study showed that the SMI assay can be used as an alternative to the in vivo Draize eye irritation test. The aim of this multi-centre study with four participating laboratories was to assess the transferability and inter-laboratory variability of the assay using 20 reference chemicals covering the whole irritancy range. The eye irritation potency of the chemicals was assessed by measuring the amount of mucus produced during a 60-min contact period with a 1% dilution, and a second 60-min treatment with a 3.5% dilution. After each contact period the protein release from the mucosal surface was measured. Linear discriminant equations were used to convert the results into the corresponding EU eye irritation categories (NI, R36 and R41). All the non-irritants were predicted correctly by the four laboratories resulting in a 100% specificity. For the R36 compounds a correct classification rate of 89% (VITO) and 100% (SPL, JNJ and UGent) was obtained. The R41 compounds were classified correctly in 78% of the cases for VITO, 89% for SPL and JNJ and 100% for UGent. We can conclude that the SMI assay is a relevant, easily transferable and reproducible alternative to predict the eye irritation potency of chemicals.
Adriaens
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E
Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, B-9000 Gent, Belgium. els.adriaens@UGent.be
Bytheway
H
H
De Wever
B
B
Eschrich
D
D
Guest
R
R
Hansen
E
E
Vanparys
P
P
Schoeters
G
G
Warren
N
N
Weltens
R
R
Whittingham
A
A
Remon
J P
JP
D023401:Animal Use Alternatives; D000818:Animals; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D005123:Eye / Q000187:drug effects* / Q000473:pathology; D007509:Irritants / Q000145:classification / Q000633:toxicity*; D007770:L-Lactate Dehydrogenase / Q000032:analysis; D008974:Mollusca / Q000502:physiology*; D009093:Mucus / Q000201:enzymology / Q000378:metabolism*; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects* / Q000378:metabolism; D018675:Toxicity Tests
D007509:Irritants; D007770:L-Lactate Dehydrogenase