राष्ट्रीय प्रजनन एवं बाल स्वास्थ्य अनुसंधान संस्थान
National Institute for Research in Reproductive and Child Health

About us:

National Center for Preclinical Reproductive and Genetic Toxicology was jointly established (Year) at the institute by the Department of Science and Technology (DST) and Indian Council of Medical Research (ICMR). The center is one among the few centers in the country that undertakes comprehensive research and testing of new molecules for pre-clinical reproductive and genetic toxicity. The center has been providing services in the area of reproductive and genetic toxicology to various academic institution and pharma industries by following the Organisation for Economic Co-operation and Development (OECD) guidelines and good laboratory practices (GLP). The facility undertakes safety as well as efficacy testing of various molecules.

Objectives of the center:

  • To undertake preclinical reproductive and genetic toxicological evaluations of test compounds following Good Laboratory Practice (GLP).
  • To delineate the mechanism of action of test compounds at cellular and molecular level usingin vitro assays and by introducing newer approaches like epigenomics, toxicogenomics and proteomics etc, to investigate toxic manifestations of the compound.
  • To provide services to public and private sectors at the national level and act as a national reference center on reproductive and genetic toxicology.
  • To create a cadre of the researchers with expertise in the area of reproductive and genetic toxicology by organizing periodic (twice a year for three years) hands-on workshops/training courses/orientation programs with special emphasis on the related techniques in accordance with GLP regulations.
  • To disseminate information on reproductive and genetic toxicology by organizing symposium, seminars and through publications.

Services
1. Safety/toxicity evaluation of chemicals or chemical products:

Toxicity evaluation in mice, rat, rabbit and marmoset
  • Acute Toxicity ( as per OECD guideline: 420, 423 and 425)
  • Sub-acute Toxicity (as per OECD guideline: 407)
  • Chronic Toxicity (as per OECD guideline: 452)

Teratogenicity (as per OECD guideline: 414)
  • Rat
  • Mice

Dermal Toxicity (as per OECD guideline: 410)
  • Rat
  • Rabbit

Reproductive Toxicity (as per OECD guideline: 414,421 and 443)
  • Segment I Effect on Reproductive Process, Fertility Studies
  • Segment II Teratological study
  • Segment III Perinatal and postnatal studies
  • Systemic Toxicity (oral/dermal), Acute, Sub-acute /sub chronic/ Chronic

Carcinogenicity and Genotoxicity (In vivo)
  • Chromosomal aberrations in bone marrow: Rat (as per OECD guideline 475)
  • Micronucleus test in bone marrow: Mice (as per OECD guideline 474)
  • DNA damage by Comet assay: Mice (as per OECD guideline 489)
  • Dominant lethal test: Rat (as per OECD guideline 478)
  • Ames Test: Salmonella typhimurium (as per OECD guideline 471)

Genotoxicity (In vitro)
  • Micronucleus: human lymphocyte (as per OECD guideline 487)
  • Chromosomal aberration: human lymphocytes (as per OECD guideline 473)
  • DNA damage by Comet assay: human lymphocytes

Cytotoxicity
  • MTT Assay

In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD 439)

Training: Centre imparts training to the student and staff  from various institutes in the area of Reproductive toxicity and genotoxicity

Facilities:
  • Histology work station including microtome, Automatic tissue processor, embedder, Stainer and cover slipping machine
  • In-vivo Imaging Work station: State of art live animal imaging work station- IVIS-III
  • High pressure liquid chromatography (HPLC)