Establishment and intra-/inter-laboratory validation of a standard protocol of reactive oxygen species assay for chemical photosafety evaluation.
J Appl Toxicol
; 33(11): 1241-50, 2013 Nov.
Article
in En
| MEDLINE
| ID: mdl-22696462
ABSTRACT
A reactive oxygen species (ROS) assay was previously developed for photosafety evaluation of pharmaceuticals, and the present multi-center study aimed to establish and validate a standard protocol for ROS assay. In three participating laboratories, two standards and 42 coded chemicals, including 23 phototoxins and 19 nonphototoxic drugs/chemicals, were assessed by the ROS assay according to the standardized protocol. Most phototoxins tended to generate singlet oxygen and/or superoxide under UV-vis exposure, but nonphototoxic chemicals were less photoreactive. In the ROS assay on quinine (200 µm), a typical phototoxic drug, the intra- and inter-day precisions (coefficient of variation; CV) were found to be 1.5-7.4% and 1.7-9.3%, respectively. The inter-laboratory CV for quinine averaged 15.4% for singlet oxygen and 17.0% for superoxide. The ROS assay on 42 coded chemicals (200 µm) provided no false negative predictions upon previously defined criteria as compared with the in vitro/in vivo phototoxicity, although several false positives appeared. Outcomes from the validation study were indicative of satisfactory transferability, intra- and inter-laboratory variability, and predictive capacity of the ROS assay.
Key words
Full text:
1
Database:
MEDLINE
Main subject:
Ultraviolet Rays
/
Pharmaceutical Preparations
/
Reactive Oxygen Species
/
Validation Studies as Topic
/
Laboratories
Type of study:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
Limits:
Humans
Language:
En
Year:
2013
Type:
Article