• Purpose: Assess approximate lethal doses (ALD) of test substances through a single administration in rodents (rats, mice) or non-rodents (dogs, primates).
• Evaluation: Observations of clinical symptoms, body weight changes, organ effects during necropsy, and acute toxicity effects.

• Purpose: Evaluate overall toxicity through repeated administration over a specified period in rodents and non-rodents.
• Evaluation: Clinical symptoms, body weight, feed/water intake, ophthalmology, ECG, hematology, clinical chemistry, histopathology, etc., to determine NOEL/NOAEL and assess dose-toxicity relationships.

• Determine appropriate dosage ranges by administering varying doses.

• Gradually increase doses to identify maximum tolerated doses.

• Identify the maximum tolerated dose for safe administration.

• Test species: Wistar Hannover, F344, SD rats.
• Administration methods: Oral gavage or diet incorporation over 24+ months.
• Evaluation: Histopathological assessment of carcinogenic lesions alongside standard toxicology endpoints.

• Test species: B6C3F1, ICR mice.
• Administration methods: Oral gavage or diet incorporation over 18-24 months.
• Evaluation: Histopathological assessment of carcinogenic lesions alongside standard toxicology endpoints.

• Test species: rasH2 TG mice, p53 TG mice.
• Administration methods: Oral gavage or diet incorporation over 6 months.
• Purpose: Rapid carcinogenicity assessment through histopathological evaluation, serving as an efficient alternative to standard studies.

• Purpose: Assess the irritative effects of substances like ointments applied topically to the skin.
• Evaluation: Test substances are applied to depilated rabbit skin to observe localized irritation, including erythema, crust formation, and edema.

• Purpose: Evaluate the irritative effects of substances that may come into contact with the mucosa or eyes.
• Evaluation: Test substances are applied to rabbit ocular mucosa to assess irritation in the cornea, iris, and conjunctiva.

• Evaluate the effects of test substances on reproductive functions and early embryonic development.
• Analyze fertility in males and females, reproductive success rates, and early embryonic survival rates.

• Assess the effects of test substances on embryonic and fetal development during pregnancy.
• Analyze teratogenic effects, growth delays, and survival rates.

• Evaluate the effects of test substances during late pregnancy and postnatal development.
• Evaluation: Analyze postnatal survival, growth, developmental abnormalities, and behavioral toxicity.

• Evaluates the mutagenic potential of substances using bacteria.

• Assess the effects of test substances on embryonic and fetal development during pregnancy.
• Analyze teratogenic effects, growth delays, and survival rates.

• Chromosome Aberration Test: Assesses chromosomal damage in cultured mammalian cells.
• Micronucleus Test: Detects micronucleus formation in cells to evaluate genetic damage.
• Gene Mutation Tests: Hprt and xprt gene mutation assays
• Thymidine kinase gene mutation assays (OECD TG 90)

• Chromosome Aberration Test: Assesses chromosomal damage in mammalian bone marrow cells.
• Micronucleus Test: Detects micronucleus formation in rodent hematopoietic cells.
• Comet Assay: Evaluates DNA single- and double-strand breaks to assess damage.
• Chromosome Aberration Test using Mammalian Spermatocytes (OECD TG 483)

• A rapid and efficient assay using red blood cells to evaluate mutagenicity.
• Features a simplified process and enhanced reliability compared to conventional tests.

• Predict potential antigenicity of test substances in humans by evaluating immunogenicity through repeated administration.
• Active Systemic Anaphylactic (ASA) Shock Response: Assesses systemic hypersensitivity reactions caused by test substances.
• Passive Cutaneous Anaphylaxis (PCA) Response: Measures localized hypersensitivity reactions on the skin.

Predict the risk of skin sensitization for topically applied pharmaceuticals and cosmetics.

• Maximization Test
• Adjuvant and Patch Test
• Adjuvant and Strip Test
• Buehler Test
• Open Epicutaneous Test

Utilize monoclonal antibodies to identify and quantify specific cell populations.
Applications

• Splenic Immune Cell Profiling: Evaluate the distribution of specific immune cells.
• Natural Killer (NK) Cell Function Test: Assess NK cell activity.

• Cardiovascular: Blood pressure, heart rate, and ECG assessments.
• Central Nervous System: Behavior, motor function, and reflex evaluations.
• Respiratory System: Respiratory rate, tidal volume, and oxygen saturation measurements.

• Additional research based on Core Battery results, tailored to the characteristics and mechanisms of test substances.

• In-depth analyses of potential side effects and long-term stability of test substances.

• Visual observation and documentation of macroscopic lesions.

• Fixation, dehydration, embedding, and slide preparation.

• H&E(Hematoxylin & Eosin)
• PAS(Periodic Acid-Schiff)
• Masson’s Trichrome
• Safranin-O

• Red blood cell, white blood cell, and platelet count analysis.
• Blood smear and morphological analysis.

• Liver, kidney, and other organ function assessments.
• Analysis of key metabolic markers and enzymes.

• Physical, chemical, and microscopic analysis.

• Cytokine and chemokine analysis.
• Utilizing ELISA and MSD platforms.

• Oral and intraperitoneal: From postnatal day 1
• Intramuscular and subcutaneous: From postnatal days 3-4
• Intravenous: From postnatal weeks 2-3

• From the abdominal vein (postnatal days 0-21)
• From the jugular vein (postnatal day 21 and later)

• Local Lymph Node Assay (LLNA):
  Using ELISA (BrdU-ELISA, OECD TG 442B)
  Using flow cytometry (BrdU-FCM, OECD TG 442B)
• Direct Peptide Reactivity Assay (DPRA, OECD TG 442C)
• Human Cell Line Activation Test (h-CLAT, OECD TG 442E)

• Reconstructed Human Cornea-like Epithelium (RhCE) test (OECD TG 492)
• Isolated Chicken Eye test method (OECD TG 438)

• Reconstructed Human Epidermis Test (OECD TG 439)
• Membrane Barrier Test for Skin Corrosion (OECD TG 435)

• In Vitro Skin Absorption Test (OECD TG 428)

• In Vitro 3T3 NRU Phototoxicity Test (OECD TG 432)