Toxicology and human health risk assessment

Toxicology and human health risk assessment

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.

Please contact us to discuss your toxicology and human health risk assessment needs.

 

Meet the Team

Lincoln Pritchard

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Theresa Neely

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Małgorzata Nepelska

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Claire McMillan

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Fabienne Ericher

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Sarah Henly

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