The bovine corneal opacity and permeability test in routine ocular irritation testing and its improvement within the limits of OECD test guideline 437.
Altern Lab Anim
; 39(1): 37-53, 2011 Mar.
Article
en En
| MEDLINE
| ID: mdl-21452913
ABSTRACT
Data on eye irritation are generally needed for the hazard identification of chemicals. As the Bovine Corneal Opacity and Permeability (BCOP) test has been accepted by many regulatory agencies for the identification of corrosive and severe ocular irritants since September 2009 (OECD Test Guideline 437, TG 437), we evaluated this alternative method for routine testing at BASF. We demonstrated our technical proficiency by testing the reference standards recommended in TG 437, and 21 additional materials with published BCOP and in vivo data. Our results matched the published in vitro data very well, but with some intentionally selected false negatives (FNs) and false positives (FPs), the concordance was 77% (24/31), with FN and FP rates of 20% (2/10) and 24% (5/21), respectively. In addition, we tested 21 in-house materials, demonstrating the utility of the BCOP assay for our own test material panel. Histopathological assessment of the corneas by light microscopy was also conducted, as this was suggested as a means of improving the identification of FNs. The histopathology corrected the classification of some FNs, but also increased the number of FPs. Parallel to the test method evaluation, we compared three new opacitometer models with the current standard device. We recommend the use of an opacitometer developed in our BASF laboratory, which has certified components and electronic data storage, resulting in what we consider to be excellent sensitivity, stability and reproducibility.
Buscar en Google
Bases de datos:
MEDLINE
Asunto principal:
Cáusticos
/
Epitelio Corneal
/
Opacidad de la Córnea
/
Irritantes
/
Alternativas a las Pruebas en Animales
Tipo de estudio:
Evaluation_studies
/
Guideline
/
Prognostic_studies
Límite:
Animals
Idioma:
En
Revista:
Altern Lab Anim
Año:
2011
Tipo del documento:
Article
País de afiliación:
Alemania