RCC Laboratories India Pvt Ltd

Good Laboratory Practice (GLP) Accreditations
• OECD GLP Accredited since January 2007 – Federal Office of Public Health, Switzerland (Swiss Medic)
• OECD GLP Accredited since March 2011 – National GLP Compliance Monitoring

Authority (NGCMA), Government of India
o India is a Full Adherent to Mutual Acceptance of Data (MAD) since 2011.
o GLP compliance monitoring is conducted by NGCMA, Government of India.

Animal Research & Welfare Accreditations
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA)
o Approval for research for commercial purposes
o Approval for breeding & trading of small laboratory animals
• Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International
o AAALAC Accredited since June 2016
o Accreditation covers Animal House and Ecotoxicology

Regulatory Approvals
• Central Insecticide Board & Registration Committee (CIB-RC)
o Approved for conducting studies related to pesticides and insecticides.

• Drug Regulatory Approvals (DCA)
o Approved by the Drug Control Administration (DCA), Government of Telangana
o Approved for drugs other than those specified in Schedules C and C1.
o Approved for drugs specified in Schedules C and (C1).

Toxicology
1. General Toxicology Studies (Regulatory & Exploratory)
2. Dermal Toxicity Testing (in vitro & in vivo)
3. Ocular Toxicology Services (in vitro & in vivo)
4. Inhalation Toxicology Services (Nose-Only Exposure)
5. Infusion Services
6. Neurotoxicity Studies

Genetic Toxicology Studies
1. Regulatory Assays (Mutagenicity, Clastogenicity, Genotoxicity)

Nonclinical Pathology Assessment Services
1. Clinical Pathology:
o Hematology
o Clinical Chemistry
o Coagulation
o Urinalysis
o Microscopy
o Bacterial/Viral Screening

2. Necropsy & Histology:
o Routine & Specialized Tissue Collection
3. Toxicologic Pathology:
o GLP/Non-GLP
o Morphometry
o Ocular Pathology
o Sperm Morphology
o Follicular Counting
o Immune Cell Analysis

4. Developmental and Reproductive Toxicology (DART) & Pathology
5. Integrated Interpretation/Risk Assessment
6. Pathology Peer Review

Developmental and Reproductive Toxicology (DART)
1. Developmental Screening Studies
2. Prenatal Developmental Study (Embryo-Fetal Development - Teratology)
3. Pre-and Post-natal Development Study
4. Extended One Generation Reproductive Toxicity Study
5. Two Generation Studies
6. Reproduction/Developmental Toxicity Screening Test
7. Combined Repeat Dose-Reproduction/Developmental Toxicity Screening

Analytical Chemistry
1. Physical-Chemical Testing
2. Analytical Method Development and Validation
3. Analysis of Dose Formulation for Toxicity Studies
4. Bioanalysis in Plasma Samples
5. Extraction Studies
6. Stability Testing
7. Identification of Unknown Compounds, Metabolites, and Degradation Products
8. Analysis of 5 Typical Production Batches
9. Determination of A.I Content and Impurities
10. Identification of Organic Impurities (GC-MS, LC-MS, NMR)
11. Characterization of Inorganic Impurities
12. Quantification of Impurities

Product Chemistry Services
1. Physical and Chemical Properties:
a. Color, Odor, Appearance, and Physical State
b. pH, Oxidation/Reduction, Chemical Incompatibility
c. Water Solubility, Wettability, Molar Absorption Coefficient
d. Solubility in Organic Solvents, Seive Analysis (Dry & Wet)
e. Hydrolysis (Tier 1 & Tier 2), Acidity/Alkalinity
f. Dissociation Constant(s), Volatility, Dust Content
g. Moisture Content, Ignition Test, Cold Test
h. Melting/Freezing Point, Partition Coefficient (n-octanol/water)
i. Boiling Point, Spectra (UV, UV/VB, IR), Tap Density
j. Density/Specific Gravity, Particle Size Distribution, Decomposition Temperatures
k. Viscosity, Corrosivity, Friability, Solvent Content, Solution Stability
l. Flammability, Photolysis, Dissolution, Flash Point
m. Vapor Pressure, Stability to Metal and Metal Ions
n. Ready Biodegradability, Self-Ignition Temperature, Absorption/Desorption
o. Flowability, Volatility, Degree of Dispersion
p. Nominal Size Range, Miscibility (Water/Organic Solvent), Iodine Index
q. Emulsion Properties, Persistent Foam, Spontaneity of Dispersion
r. Loss on Drying, Conductivity, Low-Temperature Thermal Stability
s. Weight Variation, Packaging Stability, Granulometry

Storage Stability Testing
1. Accelerated Storage Stability for Different Periods
2. Long-Term Storage Stability with Corrosion Characteristics
3. Freeze/Thaw Stability
4. Shelf Life (6, 12, 24, 30 months)

Environmental Safety Testing
1. E-Fate Services
2. Ecotoxicology Services
3. Endocrine Disruptor Screening Services
4. Residue Studies (Lab Analysis Only)

REACH Support
1. 1-10 Tons
o Physico-Chemical Properties
o Skin & Eye Irritation (in vitro)
o Skin Sensitization
o Acute Oral Toxicity
o Reverse Mutation Test (Ames-Test)
o Short-Term Aquatic Toxicity
o Growth Inhibition Aquatic Plants (Algae)
o Ready Biodegradability
2. 10-100 Tons
o Acute Skin/Eye Irritation (in vivo)
o Micronucleus Test (in vitro & in vivo)
o Chromosome Aberration Test
o Mouse Lymphoma Assay
o Acute Toxicity (Oral, Dermal, Inhalation)
o Repeated Dose Toxicity Studies (28 Days)
o Reproductive/Developmental Toxicity Screening
o Toxicokinetics
3. 100-1000 Tons
o Stability in Organic Solvents
o Micronucleus Test (Mouse Peripheral Blood)
o Long-Term Aquatic Toxicity
o Chromosome Aberration Test (in vivo)
o Comet Assay (in vivo)
o Repeated Dose Oral Toxicity (90 Days)
o Sub-Chronic Inhalation Toxicity (90 Days)
o Pre-Natal Development Toxicity Study (Rat & Rabbit)
o Bioaccumulation in Aquatic Species
4. >1000 Tons
o 52-Week Oral Toxicity Study
o Extended One & Two Generation Reproductive Toxicity Studies
o 2-Year Carcinogenicity Study in Rats
o Chronic Toxicity/Carcinogenicity Studies
o Long-Term Terrestrial & Aquatic Toxicity
o Avian Reproduction Study

Breeding Services
1. Inbred Strain:
o BALB/c Mouse
2. Outbred Strain:
o Swiss Albino Mouse
o Sprague Dawley (SD) Rat
o Wistar Rat
o Golden Syrian Hamster

Cell Line Services
1. Cell Lines
2. Working Cell Banks (WCB)
3. Master Cell Banks (MCB)
4. End-of-Production Cells (EOPC)

Oncogenicity & Tumorigenicity Testing
1. Tumorigenicity Testing (Subcutaneous inoculation in immunosuppressed nude mice)
2. Oncogenicity Testing (Lysate or extracted DNA testing in nude mice system)
3. In vivo Tumorigenicity Model (Nude mice)
4. In vivo Oncogenicity Model (Nude mice <3 days old, newborn hamsters, newborn rats)

Adventitious Agent Testing
1. Adult Swiss Albino Mice (Intracerebral/Intraperitoneal route)
2. Suckling Swiss Albino Mice (Intracerebral/Intraperitoneal route)
3. Guinea Pigs (Intracerebral/Intraperitoneal route)
4. Rabbits (Intradermal/Subcutaneous route)

Partnered Services
1. GLP Accredited Testing via European Partner (OECD GLP-compliant lab)
2. Beagle Dog Studies

Skin Sensitization Assays
1. Direct Peptide Reactivity Assay (DPRA) – OECD 442C
2. Human Cell Line Activation Test (h-CLAT) – OECD 442E

Endocrine Disruption Testing
1. Estrogen & Androgen Receptor Binding (YES/YAS Assay) – OECD/EPA

Environmental Fate (E-Fate) Studies
1. Biodegradation/Ready Biodegradability – OECD 301 A/D/F, OECD 310
2. Inherent Biodegradability – OECD 302 B
3. Special Biodegradation Tests – OECD 311 / ISO 11734, EN ISO 14851:2019, EN ISO 14852:2018
4. Hydrolysis Stability in Water – OECD 111