Toxicology and Human Health Risk Assessment Services
Cambridge Environmental Assessments (CEA) provides expert toxicology and risk assessment advice and support for: General chemicals, Plant protection products, Biocides, Foods and food contact materials, Cosmetics.
Our toxicology and risk assessment services include:
- Reviews presenting an evaluation of toxicological data, relevant exposure and expert opinion on associated risk
- Preparation of exposure assessment and risk characterisation for REACh, Biocidal Products or Plant Protection Product registrations
- Preparation of chemical safety reports (CSRs) and robust study summaries
- Preparation of Endocrine Disruptor assessments for actives and co-formulants
- Preparation of Cosmetic Product Safety Reports (CPSR)
- Expert support in the preparation of dossiers for submission to regulators
- Assistance with the interpretation of guidelines on requirements for regulatory approvals
- Strategy development for regulatory submissions, discussion and liaison with competent authorities including post submission support
- Preparation of standalone exposure assessment reports
- Developing higher-tier testing strategies
- Design, monitoring, interpretation and integration of regulatory and mechanistic studies
- Calculation of derived no-effect levels (DNEL)
- Determination and refinement of hazard classifications
- Expert waivers for hazard declassification
- Preparation of safety data sheets
- Specialist policy advice to and research for government organisations
- Expert witness
Alternative approaches
Data gaps are a common challenge for risk assessors. Many alternative approaches are now identified and recommended within Regulatory requirements and Scientific Guidance. They enable animal use and testing costs to be kept to a minimum and ensure that test methods keep pace with latest science. CEA have expertise in and use the following alternative approaches and tools:
- Threshold of no Toxicological Concern (TTC)
- Mechanism of action (MoA)
- (Q)SAR
- Read-across
- History of safe use
- Exposure based waiving
- Use of toxicological data bases (eg CompTox, OECD Toolbox)
- Application of toxicogenomics
- Assessment of bioavailability
Exposure assessment
CEA has extensive experience in higher tier exposure scenario development and in using regulatory accepted models such as:
- ECETOC TRA
- ECPA OWB
- Advanced REACH Tool
- CHESAR
- ConsExpo
- RISKOFDERM
We can advise you on the most appropriate exposure model or we can develop alternative/novel exposure estimations specific to your needs. We can also build detailed exposure scenarios using parts of several models or general principles, standards or guidelines.