[et_pb_section fb_built=”1″ _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”|2px||||”][et_pb_row _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”4_4″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”http:\/\/toxcel.com\/wp-content\/uploads\/2025\/06\/toxicology-banner.jpg” alt=”person testing chemicals” title_text=”toxicology banner” _builder_version=”4.5.3″ _module_preset=”default”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.5.3″ _module_preset=”default” custom_margin=”||-32px||false|false”][et_pb_column type=”4_4″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default” text_font=”Arial||||||||” header_font=”Arial|600|||||||” header_text_color=”#00208a” header_font_size=”32px”]<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”4_4″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_tabs active_tab_background_color=”#e5e5e5″ inactive_tab_background_color=”#35357f” active_tab_text_color=”#000000″ _builder_version=”4.5.3″ _module_preset=”default” tab_text_color=”#ffffff” body_font=”Arial||||||||” body_text_color=”#000000″ tab_font=”Arial||||||||” background_color=”#e5e5e5″ hover_enabled=”0″][et_pb_tab title=”Toxicology Expertise” _builder_version=”4.5.3″ _module_preset=”default” hover_enabled=”0″]<\/p>\n
Understanding and communicating the health and safety risks of chemicals, pesticides, and pharmaceutical products is critical to gaining regulatory approval and protecting public health.\u00a0At <\/span>toXcel, our board-certified <\/span>toxicologists (DABTs and ERTs) provide expert guidance to support your regulatory strategy with sound, <\/span>science-based toxicological evaluations. We assist chemical manufacturers, formulators, pharmaceutical <\/span>companies, personal care\/consumer product manufacturers and suppliers, trade associations, law firms, and <\/span>the food industry.<\/span>\u200b<\/p>\n Toxicology Consulting for Regulatory Submissions: <\/span><\/b>Leverage decades of experience from former senior <\/span>government scientific and regulatory reviewers and managers and industry regulatory leaders to support your <\/span>chemical, pesticide, and nonclinical drug development programs.<\/span>\u200b<\/p>\n Hazard Identification & Risk Characterization: <\/span><\/b>Evaluate existing toxicity data, design targeted studies, conduct <\/span>literature reviews, and apply weight-of-evidence approaches to define the toxicological profile of your <\/span>substance.<\/span>\u200b<\/p>\n We deliver strategic toxicology support tailored to your product and regulatory goals.<\/span>\u200b<\/p>\n [\/et_pb_tab][et_pb_tab title=”Exposure Modeling ” _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n Accurate exposure modeling is critical for assessing human health and environmental risks\u2014and for supporting product approvals and evaluations under EPA (FIFRA and TSCA), FDA, OEHHA, and other state and global regulatory frameworks.\u00a0toXcel\u00a0provides advanced exposure modeling and risk assessment services\u00a0across a wide range of products, including pesticides, antimicrobials, personal care items, cosmetics, indoor\u00a0air care products, medical devices, and cleaning agents.\u200b<\/p>\n \u200bOur team of regulatory scientists and toxicologists develops customized, product-specific exposure\u00a0assessments to inform regulatory submissions, support tolerance petitions, and proactively mitigate risk\u00a0before or during enforcement or litigation.\u200b<\/p>\n \u200b<\/p>\n [\/et_pb_tab][et_pb_tab title=”Risk Assessments ” _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n Calculating risk is a critical role in regulatory science. toXcel a<\/span><\/i>nalyzes<\/span> data<\/span> and <\/span>prepares<\/span> reports<\/span> for<\/span> human<\/span> health<\/span> risk<\/span> assessments<\/span> using<\/span> toxicological<\/span> criteria,<\/span> regulatory <\/span>guidance<\/span> documents,<\/span> standard<\/span> exposure<\/span> assumptions<\/span> for<\/span> residential<\/span> and<\/span> occupational<\/span> receptors, <\/span>and<\/span> refinements to model<\/span> assumptions<\/span> as<\/span> appropriate.<\/span> Benchmark<\/span> dose<\/span> modeling (BDM)<\/span> is commonly used in the US and internationally to analyze risk.<\/span>\u200b<\/p>\n Example<\/span><\/b> Chemicals<\/span><\/b> toXcel<\/span><\/b> has<\/span><\/b> Assessed:<\/span><\/b> Agricultural<\/span> chemicals;<\/span> turf<\/span> chemicals;<\/span> indoor<\/span> use chemicals such as <\/span>pesticides, antimicrobial chemicals, cleaning product chemicals, and byproducts such as 1,4-dioxane; and persistent <\/span>chemicals in products and environmental releases such as PFOS, PFAS, PFOA.<\/span>\u200b<\/p>\n \u200b<\/p>\n [\/et_pb_tab][et_pb_tab title=”Proposition 65″ _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n toXcel<\/i>\u2019s goal is to protect your business by minimizing regulatory risks and exposure liabilities under California\u2019s Proposition 65 (Safe Drinking Water and Toxic Enforcement Act). This law safeguards <\/span>California residents from toxic chemical exposures via products, drinking water, and the environment, <\/span>and is administered by the Office of Environmental Health Hazard Assessment (OEHHA).<\/span>\u200b<\/p>\n With extensive experience across antimicrobials, pesticides, cosmetics, personal care, cleaning <\/span>products, and medical devices, <\/span>toXcel develops product-specific exposure assessments to proactively <\/span>manage risks and defend against enforcement actions. We have successfully suspended OEHHA actions <\/span>and achieved chemical de-listings from Prop 65 \u2014 rare accomplishments that set us apart. When <\/span>warnings are unavoidable, we craft compliant, least-impactful Proposition 65 warning statements <\/span>tailored to your products.<\/span><\/p>\n [\/et_pb_tab][et_pb_tab title=”PFAS” _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n PFAS is a very hot topic in the chemical regulatory world! So what is it exactly?\u00a0PFAS (per- and polyfluoroalkyl substances) chemicals, also called \u201cforever chemicals\u201d in the media due to their prolonged presence, <\/span>consist of a large group of persistent fluorinated chemicals that have been manufactured and used as raw materials in several <\/span>industries. <\/span>Check out our PFAS White Paper for some more background information.<\/span>\u200b<\/p>\n toXcel has staff focused on PFAS and follows the numerous federal and state regulatory updates in this developing area under US <\/span>EPA\/TSCA and other regulatory bodies. <\/span>toXcel has provided technical and scientific support for client submissions of PFAS-<\/span>impurities under TSCA Section 5. <\/span>toXcel can review available information from companies to help determine their potential <\/span>liabilities related to PFAS, develop strategies related to testing, determine reporting requirements, develop risk and exposure <\/span>assessments, and help companies navigate forward in this developing area. <\/span>\u200b<\/p>\n toXcel is also familiar with the new TSCA one-time reporting rule (rule promulgated in late 2023) under TSCA, having presented on <\/span>this subject to the Household and Commercial Products Association (HCPA) regarding due diligence efforts related to PFAS (<\/span>contact <\/span>us if <\/span>you are<\/span> interested in seeing this presentation<\/span>), and is available to assist clients in understanding their reporting requirements <\/span>and how to gather the required documentation for these persistent substances. <\/span>US EPA recently extended the initial reporting <\/span>period for this one-time rule due to the Agency\u2019s budget constraints in getting set up to receive the data. But <\/span>don\u2019t<\/span> wait \u2013 the <\/span>deadlines in 2025 are still coming up fast and there is more to do than you think!<\/span>\u200b<\/p>\n [\/et_pb_tab][et_pb_tab title=”GRAS Self-Determinations” _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n toXcel\u2018s mission is to help your company achieve smooth and scientifically sound GRAS self-determinations, enabling safemarket entry of new food additives under U.S. FDA regulations. Generally Recognized as Safe (GRAS) status requires robustscientific support and expert panel endorsement.<\/p>\n [\/et_pb_tab][\/et_pb_tabs][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”4_4″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default” header_3_font=”Arial||||||||”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_column type=”2_5″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”http:\/\/toxcel.com\/wp-content\/uploads\/2025\/06\/Non-Clinical-Pharmacology-and-toxicology-Program-mockup.jpg” alt=”mockup of a Non Clinical Pharmacology and toxicology Program white paper” title_text=”Non Clinical Pharmacology and toxicology Program mockup” _builder_version=”4.5.3″ _module_preset=”default” width=”80%” module_alignment=”center”][\/et_pb_image][et_pb_text _builder_version=”4.5.3″ _module_preset=”default” min_height=”40.8px” custom_margin=”8px|||0px|false|false” custom_padding=”0px|10px||10px|false|false”][\/et_pb_text][et_pb_blurb title=”New List of Chemicals Regulated Under California Proposition 65″ image=”http:\/\/toxcel.com\/wp-content\/uploads\/2025\/07\/Cali-prop-65-1.jpg” alt=”Blue hexagon geometric pattern background” _builder_version=”4.5.3″ _module_preset=”default” header_font=”Arial|700|||||||” header_text_color=”#000000″ body_font=”Arial||||||||” body_text_align=”left” body_text_color=”#000000″ background_color=”rgba(132,169,197,0.5)” width=”80%” custom_margin=”0px|||42px|false|false” custom_padding=”15px|15px||15px|false|false”]toXcel<\/b>\u00a0<\/i>is experienced in helping companies that may potentially be affected by the requirements under Proposition 65. Read more Here<\/a><\/span><\/strong>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default” text_font=”Arial||||||||” width=”100%” custom_margin=”8px||||false|false” custom_padding=”|10px||10px|false|false”]<\/p>\n Non Clinical Pharmacology and toxicology<\/strong><\/a><\/span><\/p>\n Understanding the regulatory requirements for non\u2010clinical studies can be a challenge for any\u00a0company seeking early drug safety data development or chemical registration within the US,\u00a0<\/span>UK or EU…<\/p>\n Neurotoxicity and\u00a0<\/b>Neuropharmacology<\/b><\/a><\/span><\/p>\n The potential for substances to cause neurotoxicity in the adult, or in the developing central nervous system of the fetus, are addressed in legislation for both pharmaceuticals and chemicals…<\/p>\n Ocular Pharmacology\u00a0<\/b>& Toxicology<\/b><\/a><\/span><\/p>\n toXcel provides scientific support for stages of development of ophthalmic drugs, devices,\u00a0and ocular safety evaluation of active substances and formulated products under the di<\/span>rection of Alan Katz…<\/p>\n<\/h5>\n
Expertise in Key Toxicology Disciplines:<\/span><\/b>\u200b<\/h5>\n
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Exposure Modeling <\/strong><\/h4>\n
\u200b<\/strong>Our expertise in exposure modeling includes the following scenarios:<\/strong>\u200b<\/h5>\n
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Risk Assessments <\/strong><\/h4>\n
Our<\/span><\/b> Clients<\/span><\/b> Include:<\/span><\/b>\u200b<\/h5>\n
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Proposition 65<\/strong><\/h4>\n
PFAS<\/strong><\/h4>\n
GRAS Self-Determinations<\/strong><\/h4>\n
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We provide end-to-end support for your GRAS determination:<\/strong>\u200b<\/h5>\n
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White Papers and Other Downloadable Resources<\/strong><\/h3>\n