Plant Protection Products (PPP)

GLP Studies for Plant Protection Products (PPP)

Tests and analyzes are carried out in accordance with the principles laid down in Directive 2004/10/EC of the European Parliament and of the Council, where they are carried out to obtain data on properties or safety for human or animal health.

Physicochemical Tests

Physicochemical tests to assess the quality and formulation stability of plant protection products are carried out in accordance with the methods established by CIPAC and OECD. These tests are important for product identification, purity analysis, safety of use and shelf life.

Physicochemical Tests According to CIPAC Methods:

• CIPAC MT 3.3 - Density: Determines the mass of the product per unit volume, providing an important parameter for dosing accuracy.
• CIPAC MT 75 - pH Determination: Determines the acidic or basic character of the product. It is a critical measurement for product stability and user safety.
• CIPAC MT 53.3 - Wettability: Determines how easily products in powder or granular form wet when in contact with water.
• CIPAC MT 184 - Suspension Ability: Evaluates the extent to which suspension concentrates can remain dispersed in water.
• CIPAC MT 36 - Emulsion Stability: Tests the stability and resistance to separation of emulsion concentrates after mixing with water.
• CIPAC MT 185.1 – Wet Sieve Analysis: Evaluates formulation homogeneity by measuring the amount of large particles in wettable powders or water dispersible granules.
• CIPAC MT 171.1 - Dustiness: Determines the amount of fine dust that solid formulations can emit during application.
• CIPAC MT 172.2 - Flowability: The ability of granular formulations to flow freely is evaluated; this property affects application efficiency.
• CIPAC MT 46.3 - Accelerated Storage Test: Predicts the shelf life of products by testing their physical and chemical stability under different temperature and humidity conditions.

Physicochemical Tests According to OECD Guidelines:

• OECD TG 101 - UV/Visible Spectrum: Used for identification of active substances and impurity analysis.
• OECD TG 104 - Vapor Pressure: Environmental exposure risk is assessed by measuring the tendency of the substance to vaporize.
• OECD TG 105 - Water Solubility: Provides information on transportability and bioavailability by showing how soluble the substance is in water.
• OECD TG 107 - Partition Coefficient (n-octanol/water): Indicates whether the substance is more likely to dissolve in oil or water; environmental behavior and bioaccumulation are predicted.

In Vivo Tests: "Six-Pack"

The toxicological profile of plant protection products is determined by in vivo tests as defined by the OECD. In particular, these tests cover basic toxicity analyses known as "six-pack" and assess short-term effects on living organisms.

• OECD TG 420 / 423 - Acute Oral Toxicity: Assesses the acute toxic effects on the organism following oral administration of a single dose of the substance.
• OECD TG 402 - Acute Dermal Toxicity: Examines the adverse effects that may occur by dermal ingestion of the test substance.
• OECD TG 403 - Acute Inhalation Toxicity: Analyzes the toxic effects that may be caused by the substance ingested by inhalation.
• OECD TG 404 - Skin Irritation/Corrosion: Assess the damage (reversible or permanent) that the substance may cause to the skin with a single application.
• OECD TG 405 - Eye Irritation/Corrosion: Measures the potential risk of irritation or damage in contact with the eyes.
• OECD TG 406 - Skin Sensitization: The potential of the substance to cause allergic reactions (contact dermatitis) by repeated skin contact is analyzed.

These "six-pack" tests are essential studies required by regulatory authorities to make a preliminary assessment of the risks to human health posed by plant protection products.