Environmental
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Physical Chemistry
Product chemistry studies are required to characterize the substance and to provide an indication of any direct hazards (flammability, explosivity, etc.) or potential hazards (solubility, partition coefficient, etc.) to man and the environment.
Data requirements for registration of agrochemicals within the European Union are outlined in Annex II (active substances) and Annex III (formulated products) of Directive 91/414/EEC.
Within the United States, EPA OPPTS Assessment Guidelines 830 series, include 830.158 (Product identity, composition and analysis) and Series 830.6000 and 830.7000 (Physical/Chemical Properties).
Where possible, combined protocols can be offered to ensure compliance with both regulatory systems.
Covance provides a complete product chemistry service to meet the above and other regulatory requirements e.g., Annex V of Directive 92/32/EEC (Notification of New Chemical Substances) and FDA Environmental Assessment (Federal Register April 1985, 50 FR 16636). Examples of studies available include:
- Color
- Specific gravity
- Dissociation constant
- Flammability
- Viscosity
- Auto-ignition temperature
- Physical state
- Oxidizing properties
- Octanol/water miscibility
- Solubility
- Melting point
- Vapor pressure
- Partition coefficient
- Explosive properties
- Corrosion
- 5 batch analysis
- Boiling point
- pH
- Storage stability
- Relative density
- Bulk density
- Shelf life
- GLP nitrosamine analysis.
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