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Est.1979

Providing Integrated Research Solutions in Preclinical Biology

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The Biocidal Products Regulation covers a wide range of products types (i.e., rodenticides and disinfectants, preservatives etc.). Biocides can be added to the material which can protect from biological growth. Examples: Quaternary ammonium compounds can be added to the pool water to act as an algicide.

DRF is Offering complete solutions to guide you through the world of biocide regulations. DRF is generating data for submission in United States and European Union. Biocide registration includes Physico-chemical, toxicological and Genotoxicology data and the effectiveness of the Active ingredient.

The toxicology expertise at DRF comprises of a broadrange of preclinical studies with rodents and non-rodents. The studies are spread across the fields of:  Acute, In Vitro and In Vivo Mutagenicity using various routes of administration. These studies are performed in compliance with global regulatory guidelines, such as EU, OECD, OPPTS, JMAFF, CIB, EMA etc. Services
  • Acute Toxicity Studies
  • Oral
  • Dermal
  • Inhalation
  • Acute Dermal irritation
  • Acute Eye Irritation,
  • Skin Sensitization
  • M & K Method
  • Buehler Method

The toxicology expertise at DRF comprises of a wide assortment of preclinical studies with rodents and non-rodents.  The studies are stretched over a scale of specialities, viz. sub-acute, sub-chronic, chronic, DART with using various routes of administration, in vitro and in vivo mutagenicity. These studies are performed in compliance with global regulatory guidelines, viz., OECDEC, JMAFF, KCR, OCSPP.                

    Repeat Dose Studies in Rodents and Non-Rodents

  • Sub-acute Toxicity 14 days DRF and 28 days (OECD 407)
  • Sub-chronic Toxicity (90 days) (OECD 408)
  • Chronic Toxicity (180 and 360 days)
  • Carcinogenicity and Combined Carci (OECD 451, 452 and 453)

Developmental and Reproductive Toxicology

  • Reproduction/Developmental Toxicity Screening Test (OECD 421)
  • Combined Repeated Dose Toxicity Study with Reproduction / Developmental Toxicity Screening (OECD 422)
  • Prenatal Developmental toxicity (rats and rabbits; OECD 414)
  • Two-Generation Reproduction Toxicity (OECD 416)
  • Extended one generation (OECD 443)

Developmental neurotoxicity (OECD 426)

The department of Genetic Toxicology is highly
equipped to help our clients address their concerns
regarding that several substances stimulate
mutations in experimental systems. Various tests
based on expanded mutagenic impacts have been
recommended by OECD, as well as OPPTS
(OCPSS), for evaluation of mutagenic potential of
the test chemicals. DRF conducts the following
tests strictly adhering to required guidelines: In
VitroBacterial Reverse Mutation Test (Ames test)
using Salmonella typhimurium and E. coli

  • WP2uvrA:– In Vitro and In Vivo Mammalian Chromosome Aberration Test using Chinese Hamster Ovary – K1 cell line
  • In Vivo:-In Vivo Mammalian Erythrocyte Micronucleus Test in Mice/Rat (With and without
    toxicokinetic)

DRF has the full competence to perform DART Studies as per OECD, OPPTS (OCPSS)EU, JAPAN and with other international guidelines to determine the safety of pesticides and other household or industrial chemicals.
Also, DRF can assess epididymal sperm reserves sperm motility, homogenization resistant sperm headcounts and sperm morphology to access abnormalities, which forms an integral part in two-generation toxicity studies.

Type of study done at DRF  

  • Embryo-fetal
  • Reproduction and development toxicity study
  • Generation study
  • vFertility study

Species: Rat, Mice

Route of administration: Oral (gavage, dietary and drinking water), Intravenous, Intramuscular, Subcutaneous.

Toxicokinetics: Plasma/Serum samples, Fetus/Pup blood.

Parameters generally performed in adult as well as pups:

  • Soft tissue examination
  • Cephalic evaluation
  • Skeletal evaluation with Single or Double staining (done by an experienced pathologist and SDs)
  • Visceral examination
  • Neurobehavioral observation and sensory observations
  • Physical developmental
  • Functional observation battery
  • Auditory startle test
  • Histopathology (with peer review done by Experienced Pathologists of more than 35 years)
  • Estrous cycle evaluation and
  • Sperm analysis

DRF has extensive experience in analytical and bioanalytical method development and validation for a variety of platforms. Our method development and validation teams utilize a wide range of analytical techniques to meet client’s specific analytical needs. Our highly skilled method development scientists work seamlessly across varied products, methods and analytical technologies ensuring that our clients receive nothing but the best expertise.

At DRF, quality and safety are not only an essential part of our delivery, but it is also an integral part of our ethos.

We ensure Total Quality Assurance expertise to help our clients not only to meet the requirement but to exceed quality, safety and regulatory standards.

With our expertise in both, analytical chemistry and bioanalytical we are geared to support product development of a variety of pharmaceuticals, agrochemical, industrial chemical and UVCB’s.

DRF method development and validation facility are well equipped with hyphenated instrumental techniques:    

  • HPLC-UV/PDA
  • Liquid Chromatography- Triple Quadrupole System (LC-MS/MS)
  • Gas Chromatography- Triple Quadrupole System (GC-MS/MS)
  • Gas Chromatography-FID
  • Inductively coupled plasma mass spectrometry (ICP/MS)
  • Ion Chromatography-Conductivity and Electrochemical Detector
  • Differential Scanning Calorimeter
  • Thermo Gravimetry Analyzer
  • Fourier-transform infrared Spectrophotometer (FTIR)
  • UV-VIS Spectrophotometer

Various regulatory directives require preliminary 5 batch analysis ahead of pesticide registration in agrochemical industries. ‘5 batch’ involves analyzing 5 or more production batches of a pesticide and other agrochemicals to evade the impurities by identifying and quantifying them above a set threshold. Through our sequential process, we here at DRF deal with many compounds and champion impurity profiling.

This consolidation of testing and providing the data is critical as it saves our clients time and money in their regulatory submissions.

All testing is required for 5 batch and dioxins analysis is done in compliance with Good Laboratory Practice (GLP) standards.

For pesticide registration in the agrochemical industry, a Preliminary (5-Batch) Analysis is a pre-requisite according to various Regulatory Directives.

  • Europe: Regulation (EC) 1107/2009, Commission Regulation (EU)
  • 283/2013, SANCO 3030/99
  • US-EPA: OPPTS 830.1700, OPPTS 830.1800
  • Brazil Requirement
  • Worldwide: FAO or IUPAC specifications on toxicological relevant impurities. Five Batch Analysis is conducted in the following steps:
  • Pre-screening of 5-batches for impurities including 3D screening
  • Characterization of 5 commercial batches along with reference standards by UV, IR, NMR, LC-MS/MS and/or GC-MS as applicable
  • Impurity identification and structure elucidation
  • Obtain the impurities via an approved third-party specialist chemical synthesis company
  • Analysis of 5-batches using validated analytical methods for active ingredient content and impurities in compliance with GLP
  • 2D and 3D techniques of chromatography along with spectrometry, per client/geography specific regulatory guidelines.

DRF has a well-equipped facility with hyphenated instrumental techniques for conducting Five-Batch Analysis:

  • HPLC-UV/PDA
  • Liquid Chromatography- Triple Quadrupole System (LC-MS/MS)
  • Gas Chromatography- Triple Quadrupole System (GC-MS/MS)
  • Gas Chromatography-FID
  • Inductively coupled plasma mass spectrometry (ICP/MS)
  • Ion Chromatography-Conductivity and Electrochemical Detector
  • Differential Scanning Calorimeter
  • Thermo Gravimetry Analyser
  • Fourier-transform infrared Spectrophotometer (FTIR)
  • UV-VIS Spectrophotometer

DRF provides all the characterization and physicochemical testing studies required for registration worldwide. Our broader experience includes both active ingredients and formulations. Our team has conducted many successful phys-chem projects for various agrochemical products including pesticides, insecticides, herbicides, fungicides and biocides.

We generate data based on the physical, chemical and technical properties of plant protection products and other chemicals as per the relevant regulations and guidelines.

Our reports and data have been successfully accepted in support of numerous registrations throughout Europe, North America and Asia. The studies are conducted with full compliance of EC, EPA (OCSPP), ASTM, ABNT, OECD, SANCO, CIPAC, WHO-FAO, CRD and others.

At DRF, we carry out Physico-chemical Studies for below-mentioned formulations:

  • Emulsifiable Concentrates (EC)
  • Aqueous Suspoemulsions (SE),
  • Water Dispersible Granules (WG),
  • Suspension Concentrates (SC),
  • Wettable Powders (WP),
  • Soluble Concentrates (SL),
  • Emulsions in oil/ Water (EW),
  • Aqueous Capsule Suspensions (CS), etc.

Studies specific to any other formulation can be conducted as required.

Our result-oriented team has a wealth of experience for following Physico-chemical studies:

  • Melting point/melting range (OECD 102)
  • Boiling point/boiling range (OECD 103)
  • Density (OECD 109)
  • Vapour pressure (OECD 104)
  • Henry constant (calculation)
  • pH (OECD 122)
  • Physical state, colour and odour
  • Characterization by IR; NMR; GC/HPLC-MS; UV/VIS, ICP-MS
  • Water solubility (OECD 105)
  • Solubility in organic solvents (OECD 105)
  • Partition coefficient
  • Flash point (liquids) (A.9)
  • Flammability (solids) (A.10)
  • Explosive properties (OCSPP)
  • Surface tension (A.5)
  • Oxidizing properties of solids (A.17 or UN-Test O.1)
  • Particle size distribution (CIPAC MT 170)
  • Thermal stability (OECD 113)
  • Acidity, alkalinity if pH is < 4 or >9 (OECD 122 / CIPAC MT 191)
  • Viscosity (OECD 114 / CIPAC MT 192)
  • Tap density/bulk density (CIPAC MT 186)
  • Wettability (CIPAC MT 53.3)
  • Persistent foaming (CIPAC MT 47.3)
  • Dispersibility of WG (CIPAC MT 174)
  • Suspensibility (CIPAC MT 184)
  • Spontaneity of dispersion (CIPAC MT 160)
  • Wet sieve test (CIPAC MT 185)
  • Dustiness (CIPAC MT 171)
  • Friability and attrition characteristics (CIPAC MT 178)
  • Emulsion stability (MT 36.3)
  • Flowability of WG after heat test under pressure (CIPAC MT 172)
  • Pourability (CIPAC MT 148)
  • Dilution stability of herbicide aqueous solution (CIPAC MT 41)
  • Degree of dissolution and solution stability (CIPAC MT 179)
  • Dispersion stability (CIPAC MT 180)
  • Effectiveness of cleaning procedures
  • Moisture content (Karl Fisher and Dean/Stark Method)
  • Loss on drying
  • Oxidation/reduction: Chemical incompatibility
  • Corrosiveness
  • Long-term storage stability with corrosion characteristics
  • Accelerated Storage Stability Study
  • Storage stability Study with Metal and Metal ion at normal and Elevated temperature.

   Our facility is well fit-out with hyphenated instruments and all the necessary equipment required for carrying out Physico-chemical Studies as per respective guidelines:   

  • HPLC-UV/PDA
  • Liquid Chromatography- Triple Quadrupole System (LC-MS/MS)
  • Gas Chromatography- Triple Quadrupole System (GC-MS/MS)
  • Gas Chromatography-FID
  • Inductively coupled plasma mass spectrometry (ICP-MS)
  • Ion Chromatography-Conductivity and Electrochemical Detector
  • Differential Scanning Calorimeter
  • Thermo Gravimetry Analyser
  • Fourier-transform infrared Spectrophotometer (FTIR)
  • UV-VIS Spectrophotometer
  • Viscometer
  • Surface Tensiometer
  • Cryo Bath
  • Incubator
  • Peristaltic Pump
  • Hot Air Oven
  • Orbital Shaker
  • Sieve Shaker
  • Stirrer
  • Bottle Roller

Pesticide residues in feed products and food commodities is deleterious the environment and people. The analysis of agrochemical residues in fruit, vegetables and crops is vital for protecting animal and human health. Though the limits have been set by legislation for “Limit of Quantification” to identify and quantify the residue, by regulatory organizations worldwide which focus on minimizing potential dangers.  Using a full range of analytical techniques and instrumentation, we conduct subsequent validation, sample analyses, and stability testing in compliance with Good Laboratory Practice (GLP) to meet the relevant international regulatory guidelines. DRF conducts residue analysis for raw agricultural products, plant tissues, processed foods, spices, water, herbs, soils, animal tissues and more.

THE DRF Advantage:

  • We also perform independent laboratory validations to meet both the EU and EPA regulations.
  • Minimum handling errors while providing high recovery yields.
  • High purity analytical standards ensuring accurate and reproducible analysis.
  • Increased yields of extraction, reduced costs and time associated with pesticide separation.

DRF Residue Analysis facility is well equipped with a wider range of instruments:

  • HPLC-UV/PDA
  • Liquid Chromatography- Triple Quadrupole System (LC-MS/MS)
  • Gas Chromatography- Triple Quadrupole System (GC-MS/MS)
  • Gas Chromatography-FID
  • Inductively coupled plasma mass spectrometry (ICP/MS)
  • Ion Chromatography-Conductivity and Electrochemical Detector

The application of tandem LC-MS/MS and GC-MS/MS remain the primary tools in the industry for these purposes and offer optimum speed, sensitivity, reproducibility and robustness.

The toxicology expertise at DRF comprises of a wide assortment of preclinical studies with rodents and non-rodents. 

DRF can perform pyrogen test which involves measurement in the rise in temperature of rabbits following the IV injection of a sterile solution into the ear vein of rabbit.

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