TOXICITY STUDIES

At GLP Biogem Test Center our experienced and qualified staff carries out pre-clinical toxicological studies on rodents and rabbits according to the protocols required by the main international guidelines and regulations.

Toxicity Studies:

• Acute Toxicity

Acute toxicity studies provide information on the properties of the study compound for classification and risk assessment purposes.

OECD Guideline 402: Acute Dermal Toxicity - Fixed Dose Procedure

OECD Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure

OECD Guideline 423: Acute Oral Toxicity - Acute Toxic Class Method

OECD Guideline 425: Acute Oral Toxicity - Up and Down Procedure

• Sub-Chronic Toxicity

Duration: 7, 14, 28 and 90 days

Sub-chronic studies are necessary to determine the level of safety and toxicity of the compound studied by repeated administration for a relatively short period of time, in order to perform a broad series of assessments including the identification of potential target organs, toxic dose, optimal dosage levels, as well as the evaluation of other parameters, such as the palatability of a new food.

The identification of the best route of administration is very important; it means reproducing realistic human exposure condition to optimize results and increase usability and reliability.

OECD Guideline 407: Repeated Dose 28-Day Oral Toxicity Study in Rodents

OECD Guideline 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents

OECD Guideline 410: Repeated Dose Dermal Toxicity: 21/28-day Study

OECD Guideline 411: Sub-chronic Dermal Toxicity: 90-day Study

• Chronic Toxicity and Carcinogenesis

Duration: 24, 30 months

Chronic studies are needed to determine the safety and toxicity level of the substance studied by repeated administration for a period of time long enough to cover most of the life of the animals. This type of study allows you to acquire a very broad range of information on physiological, pathological and behavioral processes, to determine their possible carcinogenic effect, as well as to identify any metabolites and biological markers of the test substance.

The identification of the best route of administration is very important; it means reproducing realistic human exposure condition to optimize results and increase usability and reliability.

OECD Guideline 451: Carcinogenicity Studies

OECD Guideline 452: Chronic Toxicity Studies

OECD Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies