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, risk assessment and identification of mitigation measures for workers, consumers and bystanders: We have expertise in EU and national models such as UKPOEM, German Model, EUROPOEM I, EUROPOEM II, Dutch Greenhouse Model, ECPA Greenhouse Model, Spanish Greenhouse Model and EFSA guidance (AOEM)
- 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 and worker risk assessments. Risk mitigation measures
- Assessment of the potential for Endocrine Disruption
- Study management: Design, placement and scientific monitoring of product development programmes 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), Directive 1999/45/EC (DPD) and Global Harmonization System (GHS)
- Expert toxicology support: Preparation of toxicological position papers and liaison with regulatory authorities