Agrochemical General Toxicology

Agrochemical General Toxicology

Nowadays, general toxicology studies have been widely used in the agrochemical industry. General toxicology studies play an important role in the evaluation of new agrochemical development and help to obtain information on the safety and toxic effects of compounds prior to clinical trials. At BOC Sciences, we conduct preclinical, general toxicology studies to evaluate the safety of agrochemicals. Our extensive facilities, flexible capacity and cutting-edge laboratories mean we can conduct all general toxicology studies for your agrochemical and deliver high-quality results in a timely manner.

What is General Toxicology

General toxicology study serves as a general guide for preclinical toxicology, running the gamut from from MTD-DRF (maximum tolerated dose-dose range finding design to various durations of repeat dose studies, including 6-month or 2-year carcinogenicity studies). In general, toxicology studies are conducted in 2 species (rodents and non-rodents). Initially, studies are carried out in a stepwise manner, starting with a MTD study followed by a DRF study. The MTD and DRF studies are used to set the appropriate dose levels and, to some extent, to select species for use in repeated dose toxicity studies. Following the MTD and DRF studies, many repeat dose toxicity studies can be performed. For new agrochemicals development, there are various international regulatory guidelines, as well as specific safety information needed to support clinical research. The GLP toxicology studies required to register the activity of a new agrochemical may vary depending on the geographic market being targeted.

Application of General Toxicology

• Determine and assess the relationship between the various dose levels administered and adverse effects
• Determine any potential target organs or functions affected
• Identify the mode of toxic action
• Identify potential human and environmental risks

Features of Our Services

• Our testing process is fully compliant with Good Laboratory Practices (GLP) and relevant international regulations.
• Our extensive knowledge and years of experience in designing and conducting a full range of general toxicology studies allow us to perform acute, subacute, chronic and subchronic toxicology studies in rodent and non-rodent models.
• We can perform the overall design of the safety assessment study based on the uniqueness of the test article or class of compound.
• BOC Sciences supports a variety of facilities and capacity to meet your needs in terms of test species, routes of administration, sampling and analytics.

Figure 1. Schematic of the general toxicity mechanism. (Sabella, S.; et al. 2014)

General Toxicology Testing for Agrochemical

Acute toxicity studies

Acute and dose-range studies are used to help define and characterize the intrinsic toxicity of a new test item and to provide data for determining acute exposure to the substance. The information generated in acute studies and the assessment of dose ranges is used to guide the design and selection of dose levels for subsequent subchronic and chronic toxicity studies. We can provide recommendations for the selection of appropriate in vivo models and routes of administration to obtain optimal results in preclinical toxicology studies.

• OECD: Acute Dermal Toxicity, Acute Skin Irritation/Corrosion, Acute Inhalation Toxicity, Acute Inhalation-Fixed Concentration Procedure, Acute Eye Irritation/Corrosion, Acute Oral Toxicity-Fixed Dose Procedure, Acute Oral Toxicity: Upper and Lower Surgery
• OECD: Skin Sensitization-Local Lymph Node Assay: DA, Local Lymph Node Assay: BrdU-ELISA, In Chemical Skin Sensitization-Direct peptide reactivity assay (DPRA)

Subchronic and Chronic Studies

General toxicology programs typically include subchronic and chronic toxicity studies using rodent and non-rodent models. At BOC Sciences, the most common routes of administration for GLP toxicology studies are oral, dermal, subcutaneous, intravenous, and intramuscular.

Repeated dose toxicity studies

OECD: Repeated Dose 28-day Oral Toxicity Study in Rodents, Repeated Dose 90-Day Oral Toxicity Study in Rodents, Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents, Repeated Dose Dermal Toxicity: 21/28-day Study, Subchronic Dermal Toxicity: 90-day Study, Subacute Inhalation Toxicity: 28-Day Study, Subchronic Inhalation Toxicity: 90-day Study

Neurotoxicity and carcinogenicity studies

OECD: Neurotoxicity Study in Rodents, Carcinogenicity Studies, Chronic Toxicity Studies, Combined Chronic Toxicity/Carcinogenicity Studies

BOC Sciences Advantages

• Highly specialized technical and analytical services for the worldwide registration and regulatory compliance of agrochemicals
• Robust analytical testing programs that span from research and product development through the production process to final product
• Relies on broad industrial experience, ensuring that all of our work meets the high standards expected by our clients
• Our regulatory experts, toxicology consultants, scientists and inspectors will ensure that you receive maximum levels of guidance, testing and inspection you need.

Reference

• Sabella, S.; et al. A general mechanism for intracellular toxicity of metal-containing nanoparticles. Nanoscale. 2014. 6: 7052-7061.