Jones P A, Budynsky E, Cooper K J, Decker D, Griffiths H A, Fentem J H
Safety & Environmental Assurance Centre (SEAC), Unilever Colworth Laboratory, Sharnbrook, Bedfordshire MK44 1LQ, UK.
Altern Lab Anim. 2001 Nov-Dec;29(6):669-92. doi: 10.1177/026119290102900606.
This study compared five methods, the isolated rabbit eye (IRE), bovine corneal opacity and permeability (BCOP), EpiOcular, fluorescein leakage (FL) and neutral red release (NRR) assays, for predicting the eye irritation potential of hair-care formulations. Ten shampoo and seven conditioner formulations of known ocular irritation potential were tested. Each group included a market-acceptable formulation as a comparative benchmark. Predictions of ocular irritation were made by using classification models (IRE, BCOP and EpiOcular assays) or by direct comparison with benchmarks (IRE, EpiOcular, FL and NRR assays). The BCOP assay was less sensitive than the IRE test in discriminating between formulations of different irritation potentials, and did not perform as well as the other assays in identifying mild formulations. All of the assays appeared to be better at discriminating correctly between the shampoos than between the conditioners. The EpiOcular assay showed the closest concordance between the in vivo results and the in vitro data from cell-based assays (particularly for shampoos). The FL assay also showed a high concordance (particularly for conditioners). There was a tendency for these in vitro assays to over-predict eye irritation potential, but there was no under-prediction and they were particularly successful at identifying mild formulations. The NRR assay was less predictive with both shampoos and conditioners. The results from this comparative evaluation fully support the continued use of the IRE test as a suitable alternative to in vivo eye irritation testing in rabbits, although it also over-predicted the irritancies of several of the formulations. The value of using concurrent benchmarks (reference standards), appropriate to the materials being tested, in interpreting the data obtained from in vitro tests, was also demonstrated. Overall, the results indicate that further comparisons of the IRE, EpiOcular and FL assays are warranted using much larger numbers of test materials.
本研究比较了五种方法，即离体兔眼（IRE）、牛角膜混浊与通透性（BCOP）、眼表上皮模型（EpiOcular）、荧光素渗漏（FL）和中性红释放（NRR）试验，用于预测护发配方产品的眼刺激性。对十种已知眼刺激性的洗发水配方和七种护发素配方进行了测试。每组都包含一种市场可接受的配方作为比较基准。通过使用分类模型（IRE、BCOP和EpiOcular试验）或与基准直接比较（IRE、EpiOcular、FL和NRR试验）来预测眼刺激性。在区分不同刺激性配方方面，BCOP试验不如IRE试验敏感，在识别温和配方方面也不如其他试验表现好。所有试验在区分洗发水方面似乎比区分护发素做得更好。EpiOcular试验显示体内结果与基于细胞试验的体外数据之间的一致性最为接近（特别是对于洗发水）。FL试验也显示出高度一致性（特别是对于护发素）。这些体外试验有过度预测眼刺激性的趋势，但没有出现预测不足的情况，并且在识别温和配方方面特别成功。NRR试验对洗发水和护发素的预测性都较低。尽管该试验也过度预测了几种配方的刺激性，但本次比较评估的结果充分支持继续使用IRE试验作为兔体内眼刺激性试验的合适替代方法。还证明了在解释从体外试验获得的数据时使用与所测试材料相适应的并行基准（参考标准）的价值。总体而言，结果表明有必要使用大量测试材料对IRE、EpiOcular和FL试验进行进一步比较。
