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Toxicology Studies

AJES toxicology Studies are designed for the evaluation of toxicity of test articles. These studies may be preliminary investigations/ early toxicology for internal review or for regulatory submissions and direct extrapolation to human safety.

Regulatory Guidelines:

AJES toxicology studies are designed as per major international guidelines applicable. Some of these include OECD, US FDA, EPA, EMEA, ICH, EC, ISO or USP.

Test Systems:

AJES offers testing services in rodents and non human primates.

Routes of Administration:

  • Oral
  • Subcutaneous
  • Intravenous injection
  • Interperitoneal
  • Percutaneous
  • Dermal
  • Vaginal
  • Rectal
  • Urinary Bladder
  • Irritation and Sensitization

To determine the potential of a test material to provoke ocular, dermal irritation, or sensitization

The duration of study for Irritation - one hour to two weeks after a single topical or corneal administration, Sensitization – intra dermal or topical induction doses followed by topical challenges with a non-irritating dose

Endpoints include degree of erythema, edema, pruritis, papules, vesicles, corneal irritation, swelling, microscopic integrity of corneal endothelium, other features of the eye (conjuctive, cornea, iris, lens, opthalmascopy)

  • AMES:

Biological assay to assess the mutagenic potential of chemical compounds.

Test system includes Salmonella typhimurium TA98 and/or TA100 using 6 concentrations of the test substance in the absence of metabolic activation

Potential solvents include: USP Water for Injection (WFI), USP 0.9% Sodium Chloride for Injection (NaCl), Dimethylsulfoxide (DMSO), Acetone, 95% Ethanol (EtOH), and Cottonseed Oil.

  • Micronucleus Test:

To assess the potential of a test material to induce genetic damage in vivo and determine toxicity

An Initial range finding study is performed using a maximum dose of 2,000-mg/kg body weight followed by four lower concentrations of the test substance using rodents

End points observed are signs of toxicity, loss of weight, clinical symptoms of toxicity, alteration of ratio of immature to mature red blood cells in the bone marrow and clastogenicity is measured as the proportion of micronucleated erythrocytes

Bone marrow smears are prepared after 24 and 48 hours of treatment. The treatment groups consist of negative, test, and positive control groups. The bone marrow smears are examined to count approximately 2,000 immature and a corresponding number of mature erythrocytes per animal in each group.

Potential solvents include: USP 0.9% Sodium Chloride for Injection (NaCl) and Cottonseed Oil.

  • Chromosomal Aberration Assay:

To assess the potential of a test material to induce genetic damage in vivo and determine toxicity

The cells are exposed to the test substance at three concentrations in the presence and absence of metabolic activation

The duration of study is TK+/- mouse lymphoma or CHO HGPRT mutation assay: 14 - 18 days

Test system includes rodents, mammalian-cells

Potential solvents include: Ham’s F12, Dimethylsulfoxide (DMSO), and 95% Ethanol (EtOH)

Acute Toxicity Study

To determine LD50, MTD or NOEL of test compounds and to determine the doses for repeated dose studies

Sub-acute Toxicity Study

To determine the repeated dose toxicity of test compounds and also the doses for chronic studies

Sub-chronic Toxicity Study

To establish NOEL, to identify and characterize the specific organs affected after repeated dosing and predict the appropriate dose for chronic toxicity studies

Chronic Toxicity Study

To establish to identify the cumulative toxicity, carcinogenic potential of the test compound and characterize the specific organs affected after repeated dosing

At AJES We offer a wide range of Toxicology studies tailored to customer requirements. To learn more about these studies please contact our team.