Tox Focus, LLC

Contact: Barbara Vogt, Ph.D., Principal

65 Flint Rock Rd.
Stamford
CT 06903
U.S.A.

Phone: +1 203 355 2819
Fax: +1 203 355 2819
Email: barbara.vogt@N0SPAM.toxfocus.com
Web: http://www.toxfocus.com

Tox Focus, LLC, is a toxicology consulting practice providing the technical content of REACH registration documents (Chemical Safety Reports, Chemical Safety Assessments, Exposure Scenarios). Tox Focus can serve as a third party provider (TPR), representing a company's interest in SIEF technical discussions.

Strategic planning by Tox Focus will include consideration of computer modeling, category formation and “read-across”:
• Categorical SAR for mammalian toxicity endpoints, including mutagenicity, carcinogenicity, reproductive toxicity, sensitization, repeat-dose toxicity, etc
• OECD (Q)SAR Toolbox for ecotoxicity, environmental fate, limited mammalian toxicity
• EpiWIN, used by U.S. EPA for PreManufacturing Notice Risk Assessment
• Exposure-based data waivers
Technical data review capability includes:
• Literature review
• Klimisch validity ranking and costing of all toxicology studies
• Generation of robust summaries
• Generation of risk assessment data for Chemical Safety Assessments (NOAELS, DNELS, PNECS)
• Advocacy for scientific consensus-building, using weight of evidence approaches and balancing perspectives
• Generation of toxicology test plans
• Oversight of classification and labeling within SIEF for expanded Safety Data Sheets
• Placing, monitoring, interpreting, summarizing and auditing of required toxicology tests

Technical capability for Exposure Scenario generation is available via alliances with Industrial Hygienists:
• Application of European Targeted Risk Assessment (TRA) and EUSES tools
• Experience with setting & managing Occupational Exposure Limits (OELs)
• Feedback to support exposure-based data waiving
Guidance is also offered for strategic planning of Substances of Very High Concern (SVHCs): PBT, vPvB, CMRs (Category 1&2 vs 3) and Candidate Listing (Annex XIV). Tox Focus is a resource for socio-economic analysis plan development.

Special Expertise includes
• IUCLID 5 and REACH-IT
• Reproductive and developmental toxicity, estimated to be the greatest data outage among REACH chemicals
• Nanotoxicology and a working knowledge of testing and registration programs including OECD and the U.S. EPA’s Nanoscale Material Stewardship Program (NMSP)
• Other additional toxicology and product safety support as needed