Cormier E M, Parker R D, Henson C, Cruse L W, Merritt A K, Bruce R D, Osborne R
Procter & Gamble Far East, Inc., Kobe Technical Center, Kobe, 658, Japan.
Regul Toxicol Pharmacol. 1996 Apr;23(2):156-61. doi: 10.1006/rtph.1996.0037.
The reproducibility of toxicologic test methods, including alternative tests, is a key scientific and regulatory concern. In the present work, historic rabbit eye irritation data were used to determine the intra- and interlaboratory reproducibility of the low volume eye test (LVET). The standard Draize eye irritation test was used as the basis for comparison. The LVET and Draize tests had similar degrees of intra- and interlaboratory reproducibility as determined by examination of their coefficients of variation, although the variability in LVET results was directionally lower. Results from 70 parallel Draize and LVET tests indicated a strong positive association between results from the two tests, for corneal, iridial, conjunctival, and maximum average scores (MAS). Correlation coefficients were 0.60, 0.73, 0.69, and 0.73, respectively (P </= 0.0001). The linear relationship between LVET and Draize MAS values was examined by regression analysis and found to follow the relationship LVET MAS = 0.522 (Draize MAS). Thus, the LVET is at least as reproducible as the Draize test and gives responses that are (linearly) correlated to the Draize. The previous findings that the LVET is more predictive of human eye responses than the Draize test lends additional support for its use as a refined alternative to the Draize test.
毒理学测试方法（包括替代测试）的可重复性是一个关键的科学和监管问题。在本研究中，利用历史兔眼刺激数据来确定低容量眼测试（LVET）在实验室内和实验室间的可重复性。标准的Draize眼刺激试验用作比较的基础。通过检查变异系数发现，LVET和Draize试验在实验室内和实验室间具有相似程度的可重复性，尽管LVET结果的变异性在方向上较低。70次平行的Draize试验和LVET试验结果表明，两种试验在角膜、虹膜、结膜和最大平均得分（MAS）方面的结果呈强正相关。相关系数分别为0.60、0.73、0.69和0.73（P≤0.0001）。通过回归分析研究了LVET和Draize MAS值之间的线性关系，发现符合LVET MAS = 0.522（Draize MAS）的关系。因此，LVET至少与Draize试验一样具有可重复性，并且给出的反应与Draize试验（呈线性）相关。先前的研究发现，LVET比Draize试验更能预测人眼反应，这为其作为Draize试验的一种改进替代方法提供了额外支持。
