Regulatory Toxicology

Preamble/Overview

Regulatory toxicology group is involved in the generation of analytical data in different matrices and safety data for products. This endeavour helps the regulatory agencies to take decisions for the production, marketing, and usage of a vast variety of industrial chemicals, agro-chemicals, pharmaceuticals, cosmetic products and food/feed additives, etc. A state of the art GLP Test facility for regulatory toxicology studies has been involved in this endeavour since 2014 and the existing facilities are being upgraded following the National/International guidelines to provide scientific knowledge to society, forge linkages with industry and sustainable development around the world.
Organic pollutants are ubiquitous contaminants in ecosystems. Most of the contaminants are lipophilic and thus can be accumulated in higher trophic level organisms, get transferred through the food chain to humans and finally induce harmful effects. It is therefore critical from human health prospective to continue monitoring of residues in culinary samples collected from various parts of ecosystem. Also, it is important to develop and validate methods for rapid estimation of large number of pollutants so that timely intervention strategies can be planned.
Compliance to Good Laboratory Practices (GLPs) is the key to international acceptance of safety data/reports on industrial and consumable products. It eliminates the ground for expensive repetitions and expedites regulatory decisions which in-turn benefits both the society and the industry. CSIR-IITR is the first CSIR laboratory and second in the Government Sector to get GLP certificate for toxicity testing. Our constant efforts to expand the scope of GLP Test Facility resulted into getting certification for “Environmental studies on aquatic and terrestrial organisms” in April 2016 which makes it the only GLP certified laboratory in the government sector to carry out ecotoxicology studies.

Objectives

  • Development of newer analytical methods for characterization and quantification of chemicals
  • Toxicological/safety evaluation of chemicals and products as per GLP guidelines
  • Maintenance and supply of healthy laboratory animals for R&D programmes
  • Glimpses of Research:
    1. Anbumani S, Mohankumar MN, (2015). Nucleoplasmic bridges and Tailed nuclei are signatures of radiation exposure in Oreochromis mossambicus. Environ Sci Pollut Res Int, 22: 18425-36.
    2. Arora S, Taneja I, Challagundla M, Raju KS, Singh SP, Wahajuddin M, (2015). In vivo prediction of CYP-mediated metabolic interaction potential of formononetin and biochanin A using in vitro human and rat CYP450 inhibition data. Toxicol Lett, 239: 1-8.
    3. Bhatia T, Gupta MK, Singh P, Chauhan A, Saxena PN, Mudiam MK (2016). Sol-gel based synthetic approach for extracting highly profound and versatile drug aspirin and its metabolites in urine followed by GC-MS/MS. Bioanalysis, 8: 795-805.
    4. Chauhan AK, Mittra N, Kumar V, Patel DK, Singh C, (2015). Inflammation and B-cell lymphoma-2 associated X protein regulate zinc-induced apoptotic degeneration of rat nigrostriatal dopaminergic neurons. Mol Neurobiol, (Epub; Oct 26), PMID: 26497033.
    5. Das M, Asthana S, Singh SP, Dixit S, Tripathi A, John TJ, (2015). Litchi fruit contains methylene cyclopropyl-glycine. Curr Sci, 109: 2195-97.
    6. Jain R, Gupta MK, Chauhan A, Pandey V, Mudiam MKR, (2015). Ultrasound assisted DLLME followed by GC-MS/MS analysis for the determination of valproic acid in urine samples. Bioanalysis, 7: 2451-59.
    7. Khan S, Bhatia T, Trivedi P, Satyanarayana GNV, Mandrah K, Saxena PN, Mudiam MKR, Roy SK, (2016). Selective solid-phase extraction using molecularly imprinted polymer as a sorbent for the analysis of fenarimol in food samples. Food Chem, 199: 870-75.
    8. Kumar V, Singh BK, Chauhan AK, Singh D, Patel DK and Singh C, (2015). Minocycline rescues from zinc-induced nigrostriatal dopaminergic neurodegeneration: biochemical and molecular interventions. Mol Neurobiol, 53: 2761-77.
    9. Kumari R, Jha RR, Singh MP, Patel DK, (2016). Whirling agitated single drop microextraction technique for the simultaneous analysis of paraquat and maneb in tissue samples of treated mice. J Sep Sci, 39: 1725-33.
    10. Pahuja R, Seth K, Shukla A, Shukla RK, Bhatnagar P, Chauhan LKS, Saxena PN, Arun J, Chaudhari BP, Patel DK and Singh SP, Shukla R, Khanna VK, Kumar P, Chaturvedi RK, Gupta KC, (2015). Trans-blood brain barrier delivery of dopamine-loaded nanoparticles reverses functional deficits in parkinsonian rats. ACS Nano, 9: 4850-71.
    11. Pal A, Alam S, Chauhan LKS , Saxena PN, Kumar M, Ansari NG, Singh D and Ansari KM, (2016). UVB exposure enhanced the dermal penetration of zinc oxide nanoparticles and induced inflammatory responses through oxidative stress mediated by MAPKs and NF-κB signaling in SKH-1 hairless mouse skin. Toxicol Res, doi:10.1039/C6TX00026F.
    12. Rai S, Singh AK, Srivastava A, Yadav S, Siddiqui MH, Mudiam MKR (2016). Comparative evaluation of QuEChERS method coupled to DLLME extraction for the analysis of multiresidue pesticides in vegetables and fruits by gas chromatography-mass spectrometry. Food Anal Methods, doi: 10.1007/s12161-016-0445-2.
    13. Raju KS, Taneja I, Valicherla GR, Challagundla MK, Rashid M, Syed AA, Gayen JR, Singh SP, Wahajuddin M (2015). No effect on pharmacokinetics of tamoxifen and 4-hydroxytamoxifen by multiple doses of red clover capsule in rats. Sci Rep, 5: 16126.
    14. Ratnasekhar Ch, Singh AK, Pandey P, Saxena PN, Mudiam MKR, (2015). Identifying the metabolic perturbations in earthworm induced by cypermethrin using gas chromatography-mass spectrometry based metabolomics. Sci Rep, 5: 15674.
    15. Shukla AK, Ratnasekhar Ch, Pragya P, Chaouhan HS, Patel DK, Chowdhuri DK, Mudiam MKR, (2016). Metabolomic analysis provides insights on paraquat induced Parkinson-like symptoms in Drosophila Melanogaster. Mol Neurobiol, 53: 254-69.
    16. Shukla V, Kumari R, Patel DK, Upreti DK, (2016). Characterization of the diversity of mycosporine like amino acids in lichens from high altitude region of Himalaya. Amino Acids, 48: 129–36.
    17. Shukla V, Patel DK, Bajpai R, Semwal M, Upreti DK, (2016). Ecological implication of variation in the secondary metabolites in Parmelioid lichens with respect to altitude. Environ Sci Pollut Res Int, 23: 1391–97.
    18. Singh SP, Dwivedi N, Raju KS, Taneja I, Wahajuddin M, (2016). Validation of a rapid and sensitive UPLC–MS-MS method coupled with protein precipitation for the simultaneous determination of seven pyrethroids in 100 μL of rat plasma by using ammonium adduct as precursor Ion. J Anal Toxicol, 40: 213-21.
    19. Singh UV, Abhishek A, Bhaskar M, Tandan N, Ansari NG and Singh NP, (2015). Phyto-extraction of heavy metals and biochemical changes with Brassica nigra L. grown in rayon grade paper mill effluent irrigated soil. Bioinformation, 11: 138–44.
    20. Singhal NK, Agarwal S, Bhatnagar P, Tiwari MN, Tiwari SK, Srivastava G, Kumar P, Seth B, Patel DK, Chaturvedi RK and Singh MP, Gupta KC, (2015). Mechanism of nanotization-mediated improvement in the efficacy of caffeine against 1-methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine-induced Parkinsonism. J Biomed Nanotechnol, 11: 2211-22.
    21. Srivastav AK, Kumar M , Ansari NG, Jain AK, Shankar J, Arjaria N, Jagdale P and Singh D, (2016). A comprehensive toxicity study of zinc oxide nanoparticles versus their bulk in Wistar rats: Toxicity study of zinc oxide nanoparticles. Hum Exp Toxicol, (Epub; Feb 9), PMID: 26860690.
    22. Taneja I, Raju KS, Singh SP, Wahajuddin M, (2015). Assessment of pharmacokinetic compatibility of short acting CDRI candidate trioxane derivative, 99-411, with long acting prescription antimalarials, lumefantrine and piperaquine. Sci Rep, 5: 17264.
    23. Wahajuddin M, Singh SP, Taneja I, Raju KS, Gayen JR, Siddiqui HH, Singh SK, (2016). Development and validation of an LC-MS/MS method for simultaneous determination of piperaquine and 97-63, the active metabolite of CDRI 97-78, in rat plasma and its application in interaction study. Drug Test Anal, 8: 221-27.
    Instrumentation and Facilities
    Atomic absorption spectrometer with vapour generation and graphite tube atomiser Atomic Fluorescence Spectrometer Beta liquid scintillation counter Gas Chromatograph with tandem mass spectrometer
    Gas liquid chrmoatograph with ECD, NPD and FID High pressure liquid chromatogaph with UV and PDA detectors Muffle furnace Reduced pressure rotary evaporator
    Refrigerated centrifuge Spectrofluorimeter UV-Vis spectrophotometer Ultrapressure liquid chromatograph with electrospray ionisation tandem mass spectrometer
    Ultrapressure liquid chromatograph with UV, PDA, Fluorescence and electrochemical detectors

    Contact person:

    Dr. Poonam Kakkar

    Chief Scientist & Professor, AcSIR
    Area Coordinator, Regulatory Toxicology Group
    CSIR-Indian Institute of Toxicology Research
    Vishvigyan Bhavan
    31, Mahatma Gandhi Marg
    Lucknow - 226 001, Uttar Pradesh, India
    Phone: +91-522-2217497
    Email: pkakkar[at]iitr[dot]res[dot]in

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