Gradient

Global Regulatory Compliance

Global Chemical Registration & Notifications

Overview
Example Projects
Experts

Overview

Gradient has the chemistry, exposure, and toxicology expertise to help companies navigate and fulfill registration requirements around the world. Through well-designed data compilation, management, and analysis, we can minimize the time and resources needed to bring a new chemical to market in multiple jurisdictions. Gradient's activities in this area include overseeing physiochemical and toxicological testing, conducting hazard assessments in accordance with the Globally Harmonized System (GHS) of Classification and Labeling (accounting for country-specific requirements), and characterizing potential human health and ecological risks under various chemical use scenarios.

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Example Projects

Comprehensive Review of Bisphenol A Toxicity under REACH

Full Description

Gradient reviewed relevant scientific studies and summarized non-oral in vitro and oral in vivo toxicity studies of Bisphenol A (BPA). We prepared Robust Study Summaries under OECD GLP guidelines and Short Summaries of overall conclusions of review articles. We compiled the information in IUCLID 5 for submission to the European Chemicals Agency (ECHA) for REACH registration of BPA.

Toxicology Support for a Significant New Use Notification under TSCA

Full Description

Gradient evaluated a US EPA Significant New Use Rule (SNUR) for a chemical of interest. We reviewed toxicity data for the chemical, developed criteria for the selection of chemical surrogates to inform the toxicity assessment, and used modeling-based approaches to characterize chemical bioavailability. The collective toxicity dataset and in silico models were used to evaluate the need for SNUR toxicity tests.

Chemical Registration in Asia-Pacific Countries

Full Description

Gradient coordinated the preparation and notification of technical dossiers for several chemicals under various regulatory guidelines in a number of Asia-Pacific countries. The effort involved input on physiochemical properties, chemical hazard profiles, and expected exposures to workers, the public, and the environment.

Experts

Eric M. Dube Read Bio

Ari S. Lewis Read Bio

Daniella M. Pizzurro Read Bio

Manu Sharma Read Bio

Tim Verslycke Read Bio