Our experienced toxicology team can support our clients with:
Toxicology and non-consumer risk assessment
- Preparation of high quality active substance and product dossiers to meet international requirements (Formats: EU/dRR, OECD, WHO/JMPR, IUCLID)
- Data mining and literature reviews according to EFSA guidance
- Data gap analysis and quality checks of toxicology packages and advice on regulatory acceptance. Data bridging, read-across and data waivers.
- Exposure modelling according to various regulatory requirements, risk assessment and identification of mitigation measures for operators, workers, consumers, bystanders/residents and general public (adults and children): We have expertise in EU and national models such as EFSA guidance (AOEM), UKPOEM, German Model, EUROPOEM I, EUROPOEM II, Dutch Greenhouse Model, ECPA Greenhouse Model, Spanish Greenhouse Model, ConsExpo, ART, Risk of derm, TNsG, reverse risk assessment…
- Human health risk assessment: Selection of toxicological endpoints/points of departure for risk assessment: NOAELs, AOELs, ARfD, MOS, ADI, dermal absorption values
- Operator, bystander/resident, worker risk assessments. Risk mitigation measures.
- Assessment of the potential for Endocrine Disruption
- Study management: Design, placement and scientific monitoring to meet international testing requirements
- Study monitoring of high tier exposure studies: passive dosimetry, DFR, re-entry worker etc.
- Classification and labelling: Expert support on classification and labelling defence issues: EC 1272/2008 (CLP), and Global Harmonization System (GHS)
- Expert toxicology support: Preparation of toxicological position papers and liaison with regulatory authorities