Toxicology & Safety Assessment Services ​

Preclinical safety starts here – with scientifically robust, regulatory-compliant toxicology studies.

At IIBAT, we offer a full suite of in vitro and in vivo toxicology studies designed to meet the diverse safety assessment needs of the pharmaceutical, agrochemical, chemical, medical device, and consumer product industries. Our data supports global regulatory submissions, ensuring that your product is both safe and market-ready.

All studies are conducted under Good Laboratory Practice (GLP) and aligned with the latest OECD, ICH, FDA, EMA, and ISO guidelines.

🔍 Why Toxicology Testing Matters ​​

Toxicology studies are a critical part of any product development cycle. They provide essential data about a substance’s potential to cause harm and inform risk assessments, labelling, dosage limits, and regulatory acceptance.

Whether you’re preparing an IND, registering a pesticide, or developing a new material, our toxicology services provide the evidence base regulators demand.

🧪 Our Toxicology Capabilities

We provide a comprehensive range of in vitro and in vivo safety studies tailored to your product type, intended use, regulatory pathway, and geographic market requirements. These studies are essential for demonstrating biological safety and securing regulatory approval for pharmaceuticals, agrochemicals, industrial chemicals, and medical devices.

1. Acute Toxicity Studies

Purpose: Identify immediate hazards after a single exposure.
 Models: Oral, dermal, inhalation routes in rodents
 Outputs: LD₅₀ values, clinical signs, gross pathology

✅ OECD 420, 423, 425, 402, 403
 ✅ Required for REACH, EPA, CDSCO, and other global registrations

2. Sub-Chronic & Chronic Toxicity Studies

Purpose: Assess effects of repeated exposure over weeks or months.
 Models: 28-day, 90-day, 6-month, and 1-year studies in rodents and non-rodents
 Parameters: Hematology, organ weights, histopathology, clinical chemistry

✅ OECD 407, 408, 409
 ✅ Supports NOAEL determination and safety margin calculations

3. Genotoxicity & Mutagenicity Testing

Purpose: Detect mutations or chromosomal damage caused by the substance.

Standard test battery includes:

  • Ames test (bacterial reverse mutation – OECD 471)

  • In vitro mammalian chromosome aberration test (OECD 473)

  • In vitro micronucleus test (OECD 487)

  • In vivo micronucleus assay (OECD 474)

✅ Required under ICH S2(R1), REACH, and EPA regulations
 ✅ Performed with or without metabolic activation

4. Carcinogenicity Studies

Purpose: Assess long-term cancer risk from chronic exposure.
 Models: 18–24 month studies in rats and mice
 Endpoints: Tumor incidence, survival analysis, histopathology

✅ Required for some pharmaceuticals, industrial chemicals, food additives
 ✅ Custom protocols developed in line with ICH S1 and OECD 451–453

5. Reproductive & Developmental Toxicity Studies

Purpose: Assess potential impacts on fertility and fetal development.

Study types include:

  • Fertility studies (Segment I)

  • Embryo-fetal development (Segment II)

  • Pre- and postnatal development (Segment III)

  • Multigenerational reproductive toxicity (OECD 416)

✅ Supports regulatory submissions for drugs, chemicals, and agrochemicals
 ✅ GLP-compliant studies tailored to species and dosage design

6. Safety Pharmacology

Purpose: Evaluate effects on critical physiological systems (non-toxic endpoints).
 Systems tested:

  • Cardiovascular (e.g., ECG, blood pressure)

  • Central nervous system (e.g., motor activity, reflexes, behavior)

  • Respiratory (e.g., tidal volume, respiratory rate)

✅ In line with ICH S7A/B
 ✅ Conducted as standalone or integrated into other studies

7. Dermal & Ocular Irritation / Corrosion Studies

Purpose: Assess localized irritation or damage on contact.
Tests include:

  • Skin irritation/corrosion (OECD 404)

  • Eye irritation/corrosion (OECD 405)

  • In vitro alternatives (e.g., Reconstructed Human Epidermis models, BCOP test)

✅ Especially relevant for cosmetics, medical devices, industrial chemicals

Why Partner with IIBAT?

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GLP-compliant studies aligned with global regulations

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Dedicated scientific team with deep regulatory experience

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Integrated safety, pharmacokinetics, and analytical services