Safety studies (General and Genetic Toxicology)

Safety studies (General and Genetic Toxicology)
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We offer a variety of services within both GLP and Non-GLP settings encompassing fields such as analytical chemistry, general toxicity studies, genetic toxicity assessments, toxicokinetics/pharmacokinetics analyses, developmental and reproductive toxicology (DART) investigations, and bioanalysis. These services support the development of pharmaceuticals, biosimilars, vaccines, nutraceuticals, herbal remedies, and the safety evaluation of agrochemicals. All activities adhere to global regulatory standards set forth by organizations like OECD, ICH, and EMA, ensuring compliance for regulatory submissions worldwide.

Analytical Chemistry
Incorporate investigations such as physicochemical analysis, soil characterization, residue examination, environmental fate assessment, and metabolism studies, all essential components of regulatory submissions. Additionally, include activities related to method development, characterization, and dose formulation analysis for the test materials.
  • Packaging Testing- Agrochemicals
  • Test item Characterization
  • Physico-Chemical Properties and Five Batch Analysis
  • Method development and validation
  • Soils Characterization, Residue, Environmental Fate and Metabolism Studies
  • Dose Formulation analysis (Stability, Homogeneity and nominal concentration)
Genotoxicity
Incorporate a combination of in vitro and in vivo investigations aimed at identifying potential carcinogenic or mutagenic substances capable of inducing genetic changes in somatic or germ cells. These studies also assess the potential for DNA damage, which may impact chromosomal structure or disrupt the mitotic apparatus, leading to variations in chromosome number.
  • Local Lymph Node Assay (OECD 442 B)
  • In Vitro Skin Irritation- Reconstructed Human Epidermis Test (OECD 439)
  • In Vivo Chromosomal Aberration Test (OECD 475)
  • In Vitro Micronucleus Test (OECD 487)
  • In Vivo Mouse Erythrocytes Micronucleus Test (OECD 474)
  • Bacterial Reverse Mutation- AMES Test (OECD 471)
  • In Vitro Mammalian Chromosomal Aberration Test (OECD 473)
Repeated Dose Toxicity (Subacute, Subchronic and Chronic)
Incorporate customary Subacute, Subchronic, and Chronic Toxicity Testing investigations, encompassing thorough clinical pathology, necropsy, and organ weight measurements, alongside histopathology (either comprehensive or limited tissue evaluation).
  • Carcinogenicity study in Rat and Mice (OECD 451, ICH M3 R2)
  • Chronic Toxicity (6 -12 Months) in Rat and Mice (OECD 452, ICH M3 R2)
  • 90 Day Repeated Dose Toxicity in Rat and Mice with or without Recovery and TK (OECD 408, ICH M3 R2)
  • 28 Day Repeated Dose Toxicity in Rat and Mice with or without Recovery and TK (OECD 407, ICH M3 R2)
  • 14 Day Repeated Dose Toxicity Study in Rat and Mice with or without TK
  • Combined Chronic Toxicity/Carcinogenicity Study in Rat and Mice (OECD 453)
Reproductive & Developmental Toxicity (DART)
Incorporate assessments of Developmental and Reproductive aspects in rodent species such as mice or rats, as well as in rabbits, to assess potential impacts on both male and female reproduction and developmental outcomes. Moreover, aside from these oral route evaluations, customized studies using alternative routes of administration such as IV, SC, IM, etc., tailored for different types of test substances (e.g., Pharmaceuticals, Agrochemicals, Biosimilars, Nutraceuticals, Herbal products, etc.), can also be conducted, following GLP or Non-GLP protocols as necessary.
  • Teratogenicity/Embryo-Fetal Developmental Toxicity Study in Rabbit- Segment 2 (ICH S5 R3)
  • Teratogenicity/Embryo-Fetal Developmental Toxicity Study in Rat and Mice -Segment 2 (ICH S5 R3)
  • Fertility and Early Embryonic Development Study in Rat and Mice -Segment 1 (ICH S5 R3)
  • Prenatal Developmental Toxicity Study in Rat and Rabbits (OECD 414)
  • Combined Repeated Dose Toxicity Study with the Reproduction and Developmental Toxicity Screening Test in Rat (OECD 422)
  • Reproduction and Developmental Toxicity Screening Test in Rat (OECD 421)
  • Juvenile (Neonatal) Toxicity Study in Rat and Mice
  • Male Fertility Study in Rat
  • Pre & Postnatal Developmental Toxicity Study in Rat and Mice -Segment 3 (ICH S5 R3)
Single Dose/MTD/6 Pack Studies
Incorporate a comprehensive range of animal assessments designed to assess acute systemic toxicity via three exposure routes, as well as skin and eye irritation/corrosion, and skin sensitization.
  • Skin Sensitization Study – Guinea pig (OECD 406)
  • Ocular Irritation Study in Rabbit (OECD 405)
  • Dermal Irritation/Corrosion Study in Rabbit (OECD 404)
  • Single Dose Oral Toxicity Study in Rat (OECD 423)
  • Single Dose Dermal Toxicity Study in Rabbit (OECD 402)
  • Single Dose Dermal Toxicity Study in Rat (OECD 402)
  • Single Dose and MTD Range Finding Studies – Rat and Mice (OECD 423/425)
  • Acute Inhalation Toxicity Study in Rat (OECD 403)
ACF GHS Report