Is there a free OEL/ADE database out on the internet?
Isn’t there a database or computer program available on the Internet that will provide both the OEL and ADE for free?
Sorry there isn’t, so you can stop wasting your time searching for one right now. There’s several reason why this “free database” doesn’t exist. These reasons are as follows:
- Two groups of professionals establish OELs and ADEs, either toxicology professionals internal to a pharmaceutical company or expert consultants. Expert consultants will typically have advanced degrees, professional certifications, and decades of industry experience. Neither have the time or desire to work for free and most get paid extremely well.
- Researching and preparing the necessary documentation to support an OEL/ADE takes time and effort. Don’t be naive and discount the value of an informational product or service just because it’s not a hard tangible item (like a tablet press). Just like a pharmaceutical manufacturing company having to prepare its cGMP standard operating procedures, those require a lot of time and effort. There is no way a pharmaceutical company would just freely hand those SOPs out to the competition.
- The number of potential employees exposed to APIs, or manufacturing facilities that need to prevent cross-contamination, is relatively small when compared to the number of employees exposed to general industrial chemicals (methanol, xylene, etc.). Governmental agencies, such as OSHA and UK’s HSE, tend to focus their efforts on programs that will have the largest impact. Occupational exposures to APIs won’t get much attention from governmental agencies unless it impacts the health of a large number of employees. In addition, governmental agencies don’t even have the resources or political clout to even update their existing exposure limits. Now, with the advent of the ADE/PDE requirements for multi-product pharmaceutical manufacturing facilities, these values have the potential to impact patient populations (which will be a much larger population than a worker population), so ADE and PDEs will get attention from the applicable regulatory agencies, but there are just too many API compounds for governmental agencies to devote resources to deriving the ADE and PDE for you. Even if they did, you wouldn’t agree with their numbers anyway.
- Finally, you should also remember that the PDE, ADE, or OEL has the potential to impact multi-million dollar (or rupee) decisions. Do you really want to base that decision on some unsupported, “free” number that you found on the Internet? Get your numbers from credible sources that are well documented.
For a large catalog of OEL/ADE monographs go to OEL Fastrac.