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# Regulatory Science Associates: Regulatory Science Associates (RSA) is a UK-based regulatory science consultancy providing expert toxicology, human health exposure and risk assessment, ecotoxicology, environmental risk assessment, regulatory affairs, dossier preparation and study management services for the agrochemical, pharmaceutical, biocide and general chemical industries.

## Sitemaps
[XML Sitemap](https://regulatoryscience.com/sitemap_index.xml): Includes all crawlable and indexable pages.

## Posts
- [Regulatory Science Associates: Helping Clients Navigate the Complexities of Regulatory Science ](https://regulatoryscience.com/helping-clients-navigate-the-complexities-of-regulatory-science/): His leadership strengthens RSA’s regulatory science capability and supports delivery of high-level scientific and regulatory consulting services to clients across multiple sectors. 
- [Reviewing the thoroughness of human safety testing for succinate dehydrogenase inhibitors: fluopyram as a case study](https://regulatoryscience.com/reviewing-the-thoroughness-of-human-safety-testing-for-succinate-dehydrogenase-inhibitors-fluopyram-as-a-case-study/): This recent paper, coauthored by RSA consultants Kim Travis and Remi Bars and published in Archives of Toxicology, assesses the mammalian toxicology studies available for the succinate dehydrogenase inhibitor (SDHI) fungicide fluopyram.  The assessment was made as a case study, in light of suggestions that standard regulatory studies may not identify key toxicities related to the SDHI mode of action.  The regulatory toxicity studies with fluopyram identify primary effects on the liver and thyroid, with additional renal findings in male rats.  The mechanisms of toxicity for these findings are shown to be both unrelated to succinate dehydrogenase inhibition and not of human relevance.  Most toxicity studies with fluopyram are untargeted, but include a huge number of endpoints in order to detect toxic effects.  While effects consistent with succinate dehydrogenase inhibition would most likely be seen in the nervous system, heart and muscle; these effects are notably absent in the multiple studies available for fluopyram across different mammalian species.  It is therefore concluded that the human safety of fluopyram has been thoroughly investigated in the available studies.  The absence of effects related to succinate dehydrogenase inhibition is likely to be a consequence of the low affinity of fluopyram for the mammalian enzyme, and the rapid metabolism of fluopyram in mammalian species.
- [Applicability of kinetically-based maximum dose studies for hazard and risk assessments of the fungicide fluoxapiprolin](https://regulatoryscience.com/applicability-of-kinetically-based-maximum-dose-studies-for-hazard-and-risk-assessments-of-the-fungicide-fluoxapiprolin/): RSA consultant toxicologists Kim Travis and Dick Lewis have contributed to a recent paper, published in Regulatory Toxicology & Pharmacology.  This paper describes the hazard and risk assessment of the new fungicide fluoxapiprolin using a kinetically-based maximum dose (KMD) approach, focusing on three key long-term studies where dose levels were selected based on the KMD rather than a conventional fixed dose. Absorption of fluoxapiprolin was shown to become saturated at higher doses, supporting the use of the KMD approach. The findings show that the database is compatible with the needs of both hazard and risk assessment, and highlighting KMD as appropriate for evaluating the human hazard of new pesticide molecules.
- [Unveiling the indirect liver enzyme mediated thyroid effects of Valifenalate on rats and dogs which is not relevant to humans](https://regulatoryscience.com/unveiling-the-indirect-liver-enzyme-mediated-thyroid-effects-of-valifenalate-on-rats-and-dogs-which-is-not-relevant-to-humans/): RSA are delighted to share a link below to a collaborative publication in “Toxicology and Applied Pharmacology” describing the mode of action of the pesticide active substance Valifenalate inducing mild thyroid effects in rats and dogs in vivo. Comparative in vitro assays in rat, dog and human hepatocytes showed marked species differences in the induction of liver enzymes, T4-UGT activity and T4 disappearance.
- [Framework for classifying chemicals for repeat dose toxicity using NAMs](https://regulatoryscience.com/framework-for-classifying-chemicals-for-repeat-dose-toxicity-using-nams/): RSA consultant Kim Travis has contributed to a recent publication which looks to identify a NAMs-based classification system capable of categorising chemicals based on their bioactivity and bioavailability. The classification system, developed for human systemic toxicity, focused on repeated dose toxicity. The proposed framework integrated three lines of evidence - in silico predictions, in vitro bioavailability and PBK modelling, and in vitro bioactivity assays. Assessing twelve chemicals through the proposed framework, the authors demonstrate that the matrix suggested by the EPAA's 'NAM Designathon 2023', in which chemicals would be categorised into three levels of concern (low, medium and high), could be used. However, some further work is required to explore the range of assays used, the framework categorisation being defined, and how to fit such a matrix into a tiered approach.
- [ECETOC/RSA Thyroid Satellite Symposium Flash Report](https://regulatoryscience.com/ecetoc-rsa-thyroid-satellite-symposium-flash-report/): Back in September, we had the privilege of partnering with ECETOC to host a symposium leading up to Eurotox 2024 in Copenhagen. Several members of the RSA team, including Dr. David Andrew, Claire Grant, and Dr. Christine Walter, took part in this event.
- [Navigating Endocrine Disruption Assessment Under EU Legislation](https://regulatoryscience.com/navigating-endocrine-disruption-regulations/): Chemicals with the potential to cause endocrine disruption (ED) continue to be a focus of global chemical regulations, not least in the EU.  Chemicals registered under EU pesticide and biocide legislation have been assessed for ED potential for several years.  The Chemicals Strategy for Sustainability (CSS) is a key part of the EU’s Green Deal, and includes a strong focus on ED chemicals due to concerns over effects on human health and the environment.  The REACH and CLP regulations are seen as key measures of enforcing the CSS, with the recent introduction of new hazard classes under CLP and new ED information requirements proposed for the ongoing REACH revision.
- [Ecetoc Publication addresses dose level selection in DART studies](https://regulatoryscience.com/ecotec-publication-addresses-dose-level-selection-in-dart-studies/): RSA toxicologist Dick Lewis is lead author of a recent ECETOC publication addressing dose level selection in DART studies.  Dose level selection poses significant challenges, particularly with regard to the highest dose tested.  The paper highlights a significant divergence between ECHA recommendations and the OECD test guidelines.  The authors conclude that setting the high dose level with the aim of inducing clear signs of reproductive toxicity (as advised by ECHA) could lead to excessive and non-relevant secondary effects, with potential consequences for human health risk assessments.

## Pages
- [Biocides](https://regulatoryscience.com/sectors/biocides/)
- [Dossier Preparation](https://regulatoryscience.com/services/dossier-preparation/)
- [Study Management](https://regulatoryscience.com/services/study-management/)
- [Regulatory Affairs](https://regulatoryscience.com/services/regulatory-affairs/)
- [Technical Services](https://regulatoryscience.com/services/technical-services/)
- [Services](https://regulatoryscience.com/services/)
- [Cookie Policy](https://regulatoryscience.com/cookie-policy/): Cookie Policy Effective Date: 14-Feb-2024
Last Updated: 14-Feb-2024
What are cookies? This Cookie Policy explains what cookies are and how we use them, the types of cookies we use i.e, the information we collect using cookies and how that information is used, and how to manage the cookie settings.
Cookies are small text files that are used to store small pieces of information. They are stored on your device when the website is loaded on your browser. These cookies help us make the website function properly, make it more secure, provide better user experience, and understand how the website performs and to analyze what works and where it needs improvement.
  How do we use cookies? As most of the online services, our website uses first-party and third-party cookies for several purposes. First-party cookies are mostly necessary for the website to function the right way, and they do not collect any of your personally identifiable data.
The third-party cookies used on our website are mainly for understanding how the website performs, how you interact with our website, keeping our services secure, providing advertisements that are relevant to you, and all in all providing you with a better and improved user experience and help speed up your future interactions with our website.
  Types of Cookies we use   Manage cookie preferences Cookie Settings You can change your cookie preferences any time by clicking the above button. This will let you revisit the cookie consent banner and change your preferences or withdraw your consent right away.
In addition to this, different browsers provide different methods to block and delete cookies used by websites. You can change the settings of your browser to block/delete the cookies. Listed below are the links to the support documents on how to manage and delete cookies from the major web browsers.
Chrome: https://support.google.com/accounts/answer/32050
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If you are using any other web browser, please visit your browser’s official support documents.
  Cookie Policy Generated By CookieYes - Cookie Policy Generator.
- [General Chemicals](https://regulatoryscience.com/sectors/general-chemicals/)
- [Pharmaceuticals](https://regulatoryscience.com/sectors/pharmaceuticals/)
- [Agrochemicals](https://regulatoryscience.com/sectors/agrochemicals/)
- [Sectors](https://regulatoryscience.com/sectors/)
- [Home](https://regulatoryscience.com/)
- [Contact Us](https://regulatoryscience.com/contact-us/)
- [Blog](https://regulatoryscience.com/blog/)
- [About Us](https://regulatoryscience.com/about/)
- [Privacy Policy](https://regulatoryscience.com/privacy-policy/): Privacy Policy Last Updated On 14-Feb-2024 Effective Date 14-Feb-2024 This Privacy Policy describes the policies of Regulatory Science Associates, Kip Marina, Inverkip, Renfrewshire PA16 0AS, United Kingdom of Great Britain and Northern Ireland (the), email: jen.buchanan@regulatoryscience.com, phone: 01475 528825 on the collection, use and disclosure of your information that we collect when you use our website ( www.regulatoryscience.com ). (the “Service”). By accessing or using the Service, you are consenting to the collection, use and disclosure of your information in accordance with this Privacy Policy. If you do not consent to the same, please do not access or use the Service. We may modify this Privacy Policy at any time without any prior notice to you and will post the revised Privacy Policy on the Service. The revised Policy will be effective 180 days from when the revised Policy is posted in the Service and your continued access or use of the Service after such time will constitute your acceptance of the revised Privacy Policy. We therefore recommend that you periodically review this page. Your Rights: Depending on the law that applies, you may have a right to access and rectify or erase your personal data or receive a copy of your personal data, restrict or object to the active processing of your data, ask us to share (port) your personal information to another entity, withdraw any consent you provided to us to process your data, a right to lodge a complaint with a statutory authority and such other rights as may be relevant under applicable laws. To exercise these rights, you can write to us at jen.buchanan@regulatoryscience.com. We will respond to your request in accordance with applicable law. You may opt-out of direct marketing communications or the profiling we carry out for marketing purposes by writing to us at jen.buchanan@regulatoryscience.com. Do note that if you do not allow us to collect or process the required personal information or withdraw the consent to process the same for the required purposes, you may not be able to access or use the services for which your information was sought. Cookies Etc. To learn more about how we use these and your choices in relation to these tracking technologies, please refer to our Cookie Policy. Security: The security of your information is important to us and we will use reasonable security measures to prevent the loss, misuse or unauthorized alteration of your information under our control. However, given the inherent risks, we cannot guarantee absolute security and consequently, we cannot ensure or warrant the security of any information you transmit to us and you do so at your own risk. Grievance / Data Protection Officer: If you have any queries or concerns about the processing of your information that is available with us, you may email our Grievance Officer at Regulatory Science Associates, Kip Marina, Inverkip, email: jen.buchanan@regulatoryscience.com. We will address your concerns in accordance with applicable law. Privacy Policy generated with CookieYes.

## Team
- [Alison Brammer](https://regulatoryscience.com/our-team/alison-brammer/)
- [Alison McCondichie](https://regulatoryscience.com/our-team/alison-mccondichie/)
- [Dr Cheryl Scudamore](https://regulatoryscience.com/our-team/dr-cheryl-scudamore/)
- [Christine Walter](https://regulatoryscience.com/our-team/christine-walter/)
- [Claire Grant](https://regulatoryscience.com/our-team/claire-grant/)
- [David Andrew](https://regulatoryscience.com/our-team/david-andrew/)
- [David R Jones](https://regulatoryscience.com/our-team/david-r-jones/)
- [Diane Bewick](https://regulatoryscience.com/our-team/diane-bewick/)
- [Dr Dick Lewis](https://regulatoryscience.com/our-team/dr-dick-lewis/)
- [Gill Milburn](https://regulatoryscience.com/our-team/gill-milburn/)
- [Jen Buchanan](https://regulatoryscience.com/our-team/jen-buchanan/)
- [Dr Jenny Odum](https://regulatoryscience.com/our-team/dr-jenny-odum/)
- [Dr Jo Kilgour](https://regulatoryscience.com/our-team/dr-jo-kilgour/)
- [Juliete Da Silva](https://regulatoryscience.com/our-team/juliete-da-silva/)
- [Dr Karen Roberts](https://regulatoryscience.com/our-team/dr-karen-roberts/)
- [Dr Kevan Richardson](https://regulatoryscience.com/our-team/dr-kevan-richardson/)
- [Kim Travis](https://regulatoryscience.com/our-team/kim-travis/)
- [Lincoln Pritchard](https://regulatoryscience.com/our-team/lincoln-pritchard/)
- [Liz Macquarrie](https://regulatoryscience.com/our-team/liz-macquarrie/)
- [Dr Louise Marks](https://regulatoryscience.com/our-team/dr-louise-marks/)
- [Lynda Farrelly](https://regulatoryscience.com/our-team/lynda-farrelly/)
- [Dr Mac Provan](https://regulatoryscience.com/our-team/dr-mac-provan/)
- [Mike Coulson](https://regulatoryscience.com/our-team/mike-coulson/)
- [Paul Carter](https://regulatoryscience.com/our-team/paul-carter/)
- [Peter Cotton](https://regulatoryscience.com/our-team/peter-cotton/)
- [Dr Phil Botham](https://regulatoryscience.com/our-team/dr-phil-botham/)
- [Dr Remi Bars](https://regulatoryscience.com/our-team/dr-remi-bars/)
- [Richard Murray-Smith](https://regulatoryscience.com/our-team/richard-murray-smith/)
- [Zoe Karalli](https://regulatoryscience.com/our-team/zoe-karalli/)