ToxStrategies consulting scientists have extensive industry and regulatory experience and can assist clients in complying with the United Nation’s Globally Harmonized System (GHS). In particular, we have wide-ranging experience with GHS as it is incorporated into the Occupational Safety and Health Administration’s 2012 revised Hazard Communication Standard (OSHA HazCom, or HCS) and the EU’s Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) and Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulations. This background includes toxicological study evaluation, hazard and risk assessment, data documentation and entry, and generation of toxicological summaries and Chemical Safety Reports. ToxStrategies’ consulting services can be tailored to provide a level of support that fits your company’s needs, from managing the entire scientific program to required data entry. Selected examples of our consulting staff’s experience include the following:
Strategic planning and project set-up
- Substance identification and tonnage
- Use determination
- Determination of data requirements
- Overall project plan and timelines
Data collection and evaluation
- Physico-chemical, toxicological, ecotoxicological, environmental data types
- Literature inventory and evaluation
- Klimisch scoring and rationale documentation
- Alternative scoring criteria for specific study types
- Data gap analyses
Study design and monitoring
- In vitro and in vivo study design and management
- Study design to fill data gaps
- Identification of representative sample(s)
- Test material certification
- Assessment of laboratory qualifications
- Protocol development
- Study monitoring
- Review/write study reports
Data waving and read-across
- Read-across and QSAR
- Waiving according to Rules for Adaptation
- Exposure-based waiving
- Drafting testing proposals for higher-level vertebrate testing
Hazard assessment and classification
- Physico-chemical properties
- Toxicological
- Ecotoxicological
- PBT/vPvB
- Fate and transport
Exposure assessment
- Confidential exposure data collection
- Complex, multi-site, and multi-entity
- Exposure modeling
- On-site sampling and monitoring
Risk characterization and exposure scenarios
- Derivation of risk values (e.g., DNELs, PNECs)
- Selection and justification of assessment factors
- Preliminary exposure scenario development
- Operational conditions and risk management measures
- Site-specific risk assessments
Dossier development
- Study entries and robust summaries (e.g., in IUCLID)
- Endpoint summaries
- Chemical Safety Reports
- Technical Dossiers
- Support development of Safety Data Sheets (SDSs)
Registration, consortia, and regulatory support
- Downstream user and supply-chain communication
- Evaluation of data-sharing requests
- Scientific Information Exchange Forum (SIEF) participation
- Consortia representation
- Scientific, stakeholder, and legal working groups
- Support through evaluation, quality observation letters, and draft decisions
- Meetings with regulatory authorities
Workplace communication
- Evaluation of change in classification and/or labeling of products
- Interpretation of SDS language in context of GHS
- Interaction with multi-disciplinary teams to evaluate workplace changes under GHS
- Facilitate GHS-based lab safety plans
For more information about ToxStrategies’ consulting services, please contact us.