Toxicology and human health risk assessment

CEA provides expert advice and regulatory support for:

• chemicals under EU and UK REACH
• industrial chemicals
• chemicals in food
• chemicals in consumer products
• plant protection products
• biocides
• co-formulants

Our services include:

Data driven approaches

• toxicological data evaluation, including Klimisch (ToxRTool) scoring
• risk characterisation
• interpreting and integrating in vitro and in vivo regulatory and mechanistic studies
• endocrine disruptor (ED) assessment
• derived no-effect level (DNEL) calculation
• benchmark dose (BMD) modelling
• NAMs (new approach methodologies) incorporating  in vitro tests, read-across and (Q)SAR
• cross-reactive protein identification with AllergenOnline software
• weight-of-evidence evaluation for individual toxicological endpoints

Regulatory

• expert support for regulatory dossiers
• interpretation of regulatory guidelines
• data gap analysis (DGA) for active substances and co-formulants
• developing (higher-tier) strategies for regulatory submissions
• discussion and liaison with competent authorities
• dossier post-submission support
• chemical safety report (CSR) and robust study summary (RSS) preparation
• hazard classification and refinement
• expert waivers for hazard declassification

Exposure (including use of regulatory-accepted models)

• scenario-specific exposure assessment
• exposure-based waiving, including use of threshold of concern (TTC)
• ECETOC TRA
• ECPA OWB
• Advanced REACH Tool
• CHESAR
• ConsExpo
• RISKOFDERM
• OPEX

Literature reviews

• systematic literature reviews (including identification of “grey” literature)
• Literature Review Reports (LRRs) for plant protection product (PPP) actives

Alternative approaches and tools:

• mechanism / mode of action (MoA)
• (Q)SAR and read-across (including Toxtree and OECD Toolbox)
• assessment of bioavailability

Other

• specialist policy advice to, and research for, government organisations
• professional peer-review
• study monitoring