Literature Searching
What we do
Our scientists know that a robust risk assessment relies upon quality data. We are experienced searchers of the major toxicity databases, databanks and internet. In addition, our in-house database, TRACE, gives us valuable access to Expert Group and primary reports that are not reliably identified via searches the usual range of data sources. All of the documents on TRACE have been selected and indexed by our expert toxicologists, ensuring chemical-specific, reliable and highly efficient retrieval of relevant information. This unique combination is a key part of nearly every project we work on, and the details of our search methods are described in resulting reports with a high degree of transparency.
Search terms
We have years of experience in selecting and using search terms likely to be relevant to a client’s areas of interest, potentially saving a great deal of time that would otherwise be spent trawling through irrelevant hits. Searches of TRACE, in particular, can be focused with just a few clicks, providing a much more relevant output than comparable external databases.
Read-across
Data-poor target compounds may have data-rich structural analogues or metabolites/ precursors. With a robust read-across approach based on surrogate data, the use of Threshold of Toxicological Concern (TTC)-based risk assessments or laboratory testing on the target compound can be avoided. Our extensive expertise in this area allows us to assess and justify the relevance of read-across compounds in providing toxicological insights. We routinely run parallel literature searches on target and read-across compounds and provide a comprehensive data matrix containing the resultant bibliographic details.
Sources/strategies
When it comes to searching for toxicity data, we are ideally placed to help. For decades, we have performed searches of a tried-and-tested series of external databases (including some subscription-only packages) using searching strategies tailored to a sector. Our literature-searching skills (along with our extensive evaluation expertise) are invaluable in conducting full reviews for any chemical substance.
SDIs
In addition to performing literature searches for use in health risk assessments, we offer a “current awareness”, Selective Dissemination of Information (SDI) service. We carry out regular searches, of an agreed range of data sources, for new toxicity data on substances of commercial or research importance to specific clients, at requested intervals. This ensures that companies are always up to date on their key substances.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
