Blue Frog Scientific provides comprehensive toxicological support, guiding clients through the human safety aspects of chemical, biocide, and plant protection product registrations, regulatory updates, and compliance challenges while ensuring alignment with the latest scientific developments.
Our approach integrates data gap analysis, tailored testing strategies, interpretation of study data, and regulatory advocacy, prioritising the 3Rs principles (Replacement, Reduction, and Refinement of animal testing) and leveraging New Approach Methodologies (NAMs) wherever possible.
Regulatory Toxicology Services
Our regulatory toxicology services provide clients with the necessary expertise, guidance, and assurance that their human health assessment strategies for chemicals, biocides, and plant protection products are comprehensive and compliant with the necessary legislative information requirements.
Our services include:
- Literature Search & Systematic Review – Conducting scientific literature evaluations to support information requirements and weight-of-evidence approaches
- Data Gap Analysis & Integrated Testing Strategies – Identifying missing data and designing cost-effective, scientifically robust testing plans that align with regulatory expectations
- Regulatory Movements – Aligning compliance strategies with known upcoming regulatory and scientific movements to minimise the scope of future dossier updates
- Regulatory Response & Compliance Support – Assisting clients in reacting to regulatory changes, and efficiently responding to compliance checks and substance evaluations
- Regulatory Advocacy & Stakeholder Engagement – Representing clients before regulatory authorities, advocating for proportional and scientifically justified information requirements in compliance checks and substance evaluations
- Expertise in Key Regulatory Areas – Advising on the wider regulatory implications of emerging toxicological concerns, including:
- Developmental & Reproductive Toxicity (DART)
- Developmental Neurotoxicity (DNT)
- Endocrine Disruption (ED)
Specialist Toxicology & Technical Services
Our specialist toxicology services blend toxicological assessment of compounds with strict regulatory information requirements, to ensure relevance and reliability of toxicological data for your submission. Correct interpretation and application of these data in hazard and risk assessment are also integral to our service offering.
Our Human Safety Team provides full study design, placement, and independent monitoring services, ensuring high-quality, compliant toxicological data.
We cover all relevant toxicological areas, including:
- General Toxicology:
- Systemic toxicity evaluations through conduct of in vitro and in vivo studies
- Local toxicity evaluations for skin sensitisation, serious eye damage, and skin irritation/corrosion
- Specialist Toxicology:
- Genetic Toxicology - Assessing the mutagenic potential of compounds and genotoxic mechanisms
- Developmental & Reproductive Toxicology (DART) - Comprehensive maternal/paternal, fetal, and muiltigenerational assessments
- Endocrine Disruption - Full ED assessments in support of active substance registration or chemical substance evaluation
- Dermal Studies - Absorption, irritation, and sensitisation evaluations
- Mechanistic Toxicology - Investigating non-standard endpoints and bespoke testing strategies to understand mechanisms of action and adverse outcome pathways (AOPs)
- New Approach Methodologies - Regulatory accepted non-animal testing approaches
- Weight-of-Evidence (WoE) & Read-Across Approaches – Supporting regulatory justifications to minimise unnecessary testing and animal use
- Nanomaterials Toxicology - Addressing unique toxicological concerns associated with nanomaterials and other advanced materials
Human Health Hazard and Risk Assessment
Once the necessary data are available to comply with regulatory information requirements, substances and/or products must undergo the appropriate hazard and risk assessment process to comply with the relevant regulatory requirement. Chemicals, biocides, and plant protection products have their own hazard and risk assessment processes, which have fundamental similarities, but many differences in terms of the detail in their approach.
Our team of specialist human health risk assessors provide expert services to overcome these human health assessment challenges:
- Hazard Classification & Labelling (CLP) – Determining appropriate classification & labelling for regulatory submissions
- Hazard Assessment - Derivation of appropriate threshold values to support risk assessment (e.g. DNELs, AOELs, MRLs)
- Exposure Assessment – Quantifying exposure levels for workers, operators, consumers, and the general public (e.g. bystanders) utilising a tiered approach
- Risk Characterisation – Characterisation or risk, prescription of operational conditions and risk management measures, risk mitigation
- Safety Reporting - Documentation of safety reports (e.g. Chemical Safety Report (CSR) and Draft Assessment Reports (DAR))
- Mixture Toxicity & MAFs – Investigating and mitigating against combined exposure risks under currently evolving regulatory frameworks
Our human safety team consists of regulatory toxicologists, specialist toxicologists, and experts in exposure assessment and risk characterisation. With decades of experience spanning industry, testing laboratories, and academia, we provide the scientific expertise and regulatory insight needed to overcome your human health regulatory challenges.
Contact our human safety team today to discuss how we can support your regulatory needs.
