At K2 Tox, we provide scientifically rigorous, evidence-based toxicological consulting to help clients navigate the most challenging questions in chemical safety, product development, and regulatory compliance. Our team brings decades of experience and leadership in toxicology, human health risk assessment, regulatory science, and emerging contaminants to every project.

Our Services

Predictive Toxicology

  • Application of in silico tools (e.g., QSAR, read-across, ToxTree, DEREK, OECD Toolbox)

  • Early-phase screening of novel compounds

  • Toxicological prioritization in data-poor environments

  • Integration of computational predictions with mechanistic data

Systematic Literature Review & Weight-of-Evidence Analysis

  • Structured review of toxicological, clinical, and epidemiological data

  • Quantitative and qualitative weight-of-evidence (WoE) frameworks

  • Regulatory-grade summaries and dossiers for litigation or submission

  • Data curation and interpretation across complex or conflicting studies

Regulatory Science & Product Stewardship

  • Support for FDA submissions including Premarket Tobacco Applications (PMTAs) and GRAS determinations

  • Preparation of safety dossiers and toxicology summaries

  • EU Classification, Labelling and Packaging (CLP), and Medical Device Regulation (MDR) compliance support

  • Strategic guidance on safety, sustainability, and regulatory positioning

Exposure Assessment & Modeling

  • Exposure modeling using tools such as IHSkinPerm and EPA algorithms

  • Biomonitoring and passive dosimetry study design and interpretation

  • Evaluation of internal dose, dermal/inhalation pathways, and various exposure scenarios

  • Consumer and occupational exposure assessment

Nanotoxicology & Emerging Materials

  • Safety assessments of engineered nanomaterials (e.g., nanoparticles, carbon nanotubes)

  • Exposure modeling and risk analysis for microplastics, tire wear particles, and metal debris

  • Laboratory method development for particle detection in biological and environmental matrices

  • Assessment of materials at the nano-bio interface

Product Safety & Biocompatibility

  • Genotoxicity, carcinogenicity, and reproductive/developmental toxicity evaluations

  • Toxicological profiles for compounds in personal care and over-the-counter products

  • Biocompatibility assessments under ISO 10993

  • Safety evaluations of pharmaceuticals and medical device constituents

Toxicological Risk Assessment

  • Human health risk assessment for consumer products, pharmaceuticals, dietary supplements, and medical devices

  • Regulatory toxicology support for domestic and international frameworks (e.g., FDA, EPA, EU CLP/MDR)

  • Proposition 65 evaluations

  • Dose-response modeling and margin of safety (MoS) analysis

At K2 Tox, with more than 30 years of combined experience across academia, industry, and consulting, we have experience with a wide breadth of materials and technical areas.

Experience & Technical Areas

Compounds & Materials

  • Analytical chemistry support

  • Behavioral toxicology

  • Biocompatibility assessment (ISO 10993)

  • Biomonitoring

  • California Proposition 65 compliance & evaluations

  • Carcinogenicity evaluation

  • Chemical mapping (e.g., of environmental dust particles)

  • Clinical toxicology

  • Computational toxicology

  • Consulting support for litigation or regulatory submission

  • Consumer product safety

  • Critical review methodology

  • Contract Research Organization (CRO) coordination & oversight

  • Developmental and reproductive toxicology (DART)

  • Developmental neurotoxicity

  • Dose-response modeling

  • Endocrine disruption

  • Environmental toxicology

  • Epidemiological data evaluation & study review

  • Exposure assessment & modeling (e.g., IHSkinPerm, EPA models)

  • Genotoxicity

  • GRAS evaluations

  • Hazard classification and regulatory labeling

  • Hazard identification

  • Human health risk assessment

  • Immunotoxicology

  • In silico modeling (QSAR, read-across, etc.)

  • In vitro and in vivo mammalian toxicology

  • Internal dose estimation

  • ISO 10993 compliance

  • Literature evaluation

  • Margin of Safety (MoS) analysis

  • Medical device biocompatibility

  • Molecular toxicology

  • Nanomaterial characterization & nanotoxicology

  • Neurotoxicology

  • PBPK modeling

  • PMTA (Premarket Tobacco Application) support

  • Predictive toxicology

  • Product safety & stewardship

  • QSAR modeling (e.g., Derek Nexus, OECD Toolbox)

  • Regulatory science & support

  • REACH & EU CLP/MDR compliance

  • Risk assessment (quantitative, screening-level, & weight-of-evidence)

  • Risk prioritization & communication

  • Single-particle analysis

  • Strategic regulatory guidance

  • Structured data review

  • Sustainability & safety assessments

  • Systematic literature review

  • Systematic reviews & meta-analysis

  • Technical dossier & toxicological profile preparation

  • Toxicological risk assessment

  • Toxicology (general, molecular, & applied)

  • Weight-of-evidence analysis & frameworks

  • Acetaminophen (Paracetamol / APAP)

  • Active & inert pesticide ingredients

  • Asbestos (including friction product exposure)

  • Avobenzone

  • Bemotrizinol

  • Beta-hydroxy-beta-methylbutyrate (HMB)

  • Bisoctrizole

  • Bisdisulizole disodium

  • Carbon nanotubes

  • Cationic polystyrene nanoparticles

  • Cerium oxide nanoparticles

  • Cobalt-containing alloys

  • Cobalt dust

  • Contaminants in feminine hygiene products

  • Diacetyl

  • Diethylamino hydroxybenzoyl hexyl benzoate

  • Diesel exhaust/fumes

  • Dietary supplement compounds (e.g., HMB)

  • Ensulizole

  • Ethylhexyl triazone

  • Flavoring agents in e-cigarettes

  • Formaldehyde

  • Fullerene nanoparticles (C60)

  • Glyphosate

  • Glycol ethers

  • Homosalate

  • Hormonal compounds affecting neurodevelopment

  • Lead (Pb)

  • Metal nanoparticles

  • Metal-on-metal (MoM) hip implant wear particles

  • Microplastics

  • N-nitrosamines

  • N-nitrosodimethylamine (NDMA)

  • Nanoparticles (engineered, incidental, or environmental)

  • Nickel nanoparticles

  • Octinoxate

  • Octisalate

  • Octocrylene

  • Organic UV filters

  • Oxybenzone

  • Paraquat

  • Per- and polyfluoroalkyl substances (PFAS)

  • Perfluorooctane sulfonate (PFOS)

  • Perfluorooctanoic acid (PFOA)

  • Personal care product ingredients

  • Phthalates (e.g., DEHP, DBP)

  • Silica nanoparticles

  • Siloxanes

  • Silicone elastomers and plastics (from medical devices)

  • Sunscreen ingredients

  • Tire and road wear particles (TRWP)

  • Titanium dioxide

  • Tris-biphenyl triazine

  • Ultrafine air pollution particles

  • Zinc oxide nanoparticles

Scientific & Technical Areas