Services

Toxicology & Human Health Risk Assessment

We provide expert toxicology and human health risk assessment support for US, EU and global clients across the crop protection, biocides and antimicrobials, industrial chemicals, and cosmetics sectors. Our staff in North America and Europe have considerable experience in regulatory toxicology, including Endocrine Disruptor (ED) evaluations, as well as regulatory human health risk assessment under both US and European legislation.

Experienced Support For:

Global Regulatory Strategy
Study Design & Monitoring
Dossier Preparation & Submission
Regulatory Agency Liaison

Human Health Risk Assessment
Dietary & Non-Dietary Exposure
Endocrine Disruptor Data Review

Toxicology & Human Health Risk Assessment Support in North America

Regulatory Strategy

Preparation of toxicological position papers
Data gap analysis, quality checks of toxicology packages and advice on regulatory acceptance
Product defense and stewardship
Agency liaison to define regulatory and technical approach
Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony

Study Design, Placement & Monitoring

Design, placement, and monitoring of toxicology studies at Contract Research Organizations (CRO)
Review and interpretation of study results
Advice on compliance with Good Laboratory Practice (GLP) and Organisation for Economic Co-operation and Development (OECD) Test Guidelines

Chemical Candidate Selection

Co-ordination of toxicology screening for candidate selection
Preliminary risk assessments
Regulatory acceptability of inerts

Human Health Risk Assessment

Consumer, worker, operator and bystander risk assessments
Hazard identification, dose-response assessment, human exposure modeling, risk characterization and risk mitigation

Dossier Preparation

Preparation of high quality active ingredient and end-use/formulated product dossiers to meet international requirements
OECD, US EPA, EU, WHO/JMPR, IUCLID format dossiers
Preparation of Safety Data Sheets (SDS) per the UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
Evaluation of public domain scientific data in support of toxicological dossiers

Toxicology & Human Health Risk Assessment Support in Europe (EEA / UK)

Our toxicology support services in Europe include the European Economic Area (EEA), i.e. EU27 Member States plus Iceland, Liechtenstein and Norway, and the United Kingdom (UK).

Regulatory Strategy

Preparation of strategies to address the data and registration requirements in respect of mammalian toxicology and human health risk assessment, including Endocrine Disruptor (ED) assessments, to support EEA/UK legislation including Plant Protection Products (PPP), Biocidal Products and REACH
Data gap analysis
Agency/Member State liaison to define regulatory and technical approaches
Litigation support including data compensation evaluations, intellectual property assessment, scientific case preparation, and expert witness testimony

Study Design, Placement & Monitoring

Design, placement, and monitoring of mammalian toxicology and hazard assessment studies at Contract Research Organizations (CRO)
Review and interpretation of study results
Advice on compliance with Good Laboratory Practice (GLP) and Organisation for Economic Co-operation and Development (OECD) Test Guidelines
Advice on bespoke testing and non-validated methods

Human Health Risk Assessment (Non-Dietary)

Human health risk assessments conducted for plant protection product, biocidal active/product and REACH dossiers
Hazard assessment – evaluation of mammalian toxicology and hazard data to determine critical effects
Hazard characterisation – derivation of human health endpoint values for human risk assessment (e.g. DNELs, DMELs, AOEL, ARfD, ADI, TCC, BMD etc.)
Exposure modeling and assessment – covering key primary and secondary scenarios for consumers, operators, workers, by-standers and the general population using relevant regulatory models (e.g. Chesar, ConsExpo, RiskofDerm, ART, UK POEM, EUROPOEM, German (BBA) model)
Use and interpretation of toxicological databases (e.g. OECD Toolbox, CompTox)
Higher tier and bespoke exposure models including probabilistic methods

Dietary Risk Assessment

Derivation of human health endpoint values, e.g. Maximum residue levels (MRLs), Theoretical maximum daily intakes (TMDIs), National estimates of daily intake (NEDI) and National estimates of short-term intake (NESTI)
Determination of residues in foods and drinking water
Dietary intake and risk assessment calculations using the PRIMO model and bespoke approaches