Chemical Toxicological Risk Assessment - Overview
Chemical Risk Assessment and Toxicological evaluation of the raw materials/chemical components is a key step in delivering safe products to customers and users. Today’s market is dynamic, and innovation is a trend in the industry. Many a times, innovation is driven by the addition of novel chemical ingredients or the inclusion of existing ingredients across different product types. In such diverse scenarios, conducting the chemical risk assessment to evaluate the toxicity potential of chemical ingredients and foreseeable risk to consumers/users is of prime importance.
At Freyr, we have a team of qualified Regulatory toxicologists, certified by the American Board of Toxicology as a Diplomate of the American Board of Toxicology (DABT) and EUROTOX as a European Registered Toxicologist (ERT). The team embraces a diverse pool of experts with extensive experience in working with leading chemical and consumer companies for different product portfolios. The team also has expertise in conducting hazard identification and risk assessment, exposure assessment, and toxicological profile development for chemical ingredients, botanicals, polymers, and animal/mineral origin raw materials.
Freyr provides chemical safety consulting for hazard identification and risk assessment based on New Approach Methodologies (NAM) such as in vitro toxicity studies/assays (e.g., Adverse Outcome Pathways), in silico predictions (such as QSAR, Toxtree, etc.), novel risk assessment tools (such as read-across strategies), Threshold of Toxicological Concern (TTC) and BenchMark Dose (BMD). The team tracks information on the advancements in the novel risk assessment approaches and validates it before application, thus, helping clients align their toxicological risk assessment with the changing Regulatory framework.
Chemical Toxicological Risk Assessment - Freyr Expertise
- Toxicological Profiling of Chemicals/Botanicals, Animal-derived or Mineral-origin Components as per Current Scientific Standards, including Alternate Assessment Approach.
- Human and Environmental Risk and Exposure Assessment.
- Data Gap Closure using New Approach Methodologies (NAMs) Such as Read-across, In Silico Predictions, QSAR, High-Throughput Study/Assessment, Benchmark Dose, OECD Toolbox, Toxtree, etc.
- Toxicology Literature Search and Assessment using a Broad Range of Databases, including Both Regulatory and Non-Regulatory References.
- Customized Toxicology Report as per Regulatory Requirements.
- Derivation of Permitted Daily Exposure (PDE) and Occupational Exposure Limits (OELs).
- Exposure Assessment (Human Health and Environment).
- Establishing Occupational Exposure Bands (OEBs).
- Extractable and Leachable Assessment.
- Environmental Assessment of Human Drug.
- Regulatory Writing to Ensure Delivery of Documents with High Scientific Standards.