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Welche Tests bieten wir Ihnen?

Sehr geehrte Kundin, sehr geehrter Kunde,

INVITRO-CONNECT GmbH bietet Ihnen eine grosse Datenbank von diversen Tests für Registrierung und Forschung & Entwicklung für Chemikalien, Pharmazeutische Wirkstoffe, Kosmetika, Biozide, Pflanzenschutzmittel, Medizinprodukte und Tierarzneimittel an, welche meistens unter GLP (Gute Laborpraxis) in einem akkreditierten Prüflabor durchgeführt werden.

Weiterhin bieten wir Ihnen eine grosse Palette an diversen in vitro-Tests an unter anderem alle in vitro-Prüfungen und Tests der ECVAM anerkannten Tierversuchsalternativen.

Von der Entwicklung einer idealen Teststrategie über Labor- und Projektkoordination, Study Monitoring, Toxikologische Expertise und GLP-Inspektionen in den Kooperationslaboren. Wir liefern die finalisierten Testberichte inklusive Registrierungs-Dossier – digital und auf Papier und das weltweit.

Profitieren Sie von unserem vielseitigen Know-how, unseren erfahrenen Kooperationspartnern und einem internationalen, sehr gut organisierten Netzwerk: sorgfältig ausgewählte Experten, Toxikologen und mehr als 80 akkreditierte Prüflabore und Dienstleister mit über 20 Jahren Erfahrung in der Branche.

INVITRO-CONNECT GmbH stellt gemäss Ihren Anforderungen und Bedürfnissen für jedes Projekt das passende Kompetenz-Team zusammen. Wir kennen die Labore sowie die Fachleute und beauftragen für jede Einzelleistung diejenigen, die dafür am besten geeignet sind. Dadurch können wir die hohe Qualität der Ergebnisse gewährleisten.

In unseren Dienstleistungen mit eingeschlossen sind die Projektbetreuung, Labormanagement, Koordination und je nach Bedarf auch das Study Monitoring.

Alle Tests und Dienstleistungen bieten wir Ihnen zum besten Preis- / Leistungsverhältnis an.

Gerne sind wir auch Ihr Labortest-Dienstleister, der Ihre Projekte zuverlässig betreut, so wie wir es für viele andere zufriedene Kunden bereits tun.

Tests und Prüfungen für regulatorische Zwecke

Cytotoxicity                                                                                                                  
Test / PrüfungRichtlinie
 
Growth Inhibition Test
Direct Cell Contact
Agar Overlay Test
Colony Forming Assay
ISO 10993-5
HemocompatibilityISO 10993-4
Cytotoxicity (USP)USP <87> acc. to ISO 10993-5
Cytotoxicity Elution Test (USP)USP <87>
Plastic Class Test I - VI (USP)USP <88>
 

Bioassays                                                                                                                    
Test / PrüfungRichtlinie
  
Biological Activity Assays / Neutralisation AssaysICH Q2(R1) or appropriate guideline and recommended protocols
Normocythaemic Mouse Bioassay / ErythropoietinEuropean Pharmacopoeia monograph 1316
Urofollitropin (Follicle Stimulating Hormone, FSH)European Pharmacopoeia monograph 0958
Insulin AssaysU.S. Pharmacopoeia <121>
Cell-Based G-CSF BioassayEuropean Pharmacopoeia monograph 2206
In Vitro Receptor Binding Assays for Biosimilar Medicinal ProductsCHMP/437/04 and respective annex guideline


Biological Assays and Immunotoxicology                                                              
Test / PrüfungRichtlinie
  
ELISA Method Development
ADCC Assay
Ligand - Binding Assays
ICH 2A/2B (Q2(R1)) or appropriate guideline and recommended protocols
 NK Cell Assay
CTL Assay
Immunophenotyping
 NK Cell Assay FDA (CDER) Guidance for Industry: S8 immunotoxicity studies for human pharmaceuticals


Bioanalytics, DMPK, ADME, PK/PD                                                                          
Test / PrüfungRichtlinie
  
BioanalyticsFDA Guidance for Industry: Bioanalytical Method Validation, May 2001
DMPK (in vitro Drug metabolism and Pharmakokinetik)FDA guidance for industry: “ Drug Interaction Studies – Study Design, Data Analysis and Implications for Dosing and Labeling” (Draft Guidance, 2006) and “Bioanalytical Method Development” (2001)
Pharmacokinetic – in vivoICH S 3 A or appropriate guideline and recommended protocols


Irritation Potential in vitro                                                                                          
Test / PrüfungRichtlinie
  
Eye Irritation (HET CAM)published protocol
Eye Corrosion (BCOP)published protocol
RBC - Testpublished protocol


Physical Chemical Properties                                                                                    
Test / PrüfungRichtlinie
  
UV-VIS Absorption SpectraOECD 101; OCSPP 830.7050
Melting Point/ Melting RangeOECD 102; OCSPP 830.7200
Boiling PointOECD 103; OCSPP 830.7220
Vapour PressureOECD 104; OCSPP 830.1620, 830.1650, 830.1670, 830.1700, 830.1750, 830.1800, 830.1900, 830.7950
Water SolubilityOECD 105; OCSPP 830.7840
Adsorption -- Desorption Using a Batch Equilibrium MethodOECD 106; OCSPP 835.1220, 835.1230
Partition Coefficient (n-octanol/water): Shake Flask MethodOECD 107; OCSPP 830.7550
Complex Formation Ability in WaterOECD 108
Density of Liquids and SolidsOECD 109; OCSPP 830.7300
Particle Size Distribution/ Fibre Length and Diameter DistributionsOECD 110; OCSPP 830.7520
Hydrolysis as a Function of pHOECD 111; OCSPP 835.2110, 835.2120
Dissociation Constants in WaterOECD 112; OCSPP 830.7370
Screening Test for Thermal Stability and Stability in AirOECD 113; OCSPP 830.6317
Viscosity of LiquidsOECD 114; OCSPP 830.7100
Surface Tension of Aqueous SolutionsOECD 115
Fat Solubility of Solid and Liquid SubstancesOECD 116
Partition Coefficient (n-octanol/water), HPLC MethodOECD 117; OCSPP 830.7570
Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation ChromatographyOECD 118
Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation ChromatographyOECD 119
Solution/Extraction Behaviour of Polymers in WaterOECD 120
Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)OECD 121
Determination of pH, Acidity and AlkalinityOECD 122
Partition Coefficient (1-Octanol/Water): Slow-Stirring MethodOECD 123


Effects on Biotic Systems                                                                                           
Test / PrüfungRichtlinie
  
Freshwater Alga and Cyanobacteria, Growth Inhibition TestOECD 201
Daphnia sp. Acute Immobilisation TestOECD 202; OCSPP 850.1300
Fish, Acute Toxicity TestOECD 203; OCSPP 850.1075 (Draft)
Fish, Prolonged Toxicity Test: 14-Day StudyOECD 204
Avian Dietary Toxicity TestOECD 205
Avian Reproduction TestOECD 206
Earthworm, Acute Toxicity TestsOECD 207
Terrestrial Plant Test: Seedling Emergence and Seedling Growth TestOECD 208
Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)OECD 209
Fish, Early-life Stage Toxicity TestOECD 210; OCSPP 850.1400
Daphnia magna Reproduction TestOECD 211
Fish, Short-term Toxicity Test on Embryo and Sac-Fry StagesOECD 212
Honeybees, Acute Oral Toxicity TestOECD 213
Honeybees, Acute Contact Toxicity TestOECD 214
Fish, Juvenile Growth TestOECD 215
Soil Microorganisms: Nitrogen Transformation TestOECD 216
Soil Microorganisms: Carbon Transformation TestOECD 217
Sediment-Water Chironomid Toxicity Using Spiked SedimentOECD 218
Sediment-Water Chironomid Toxicity Using Spiked WaterOECD 219
Enchytraeid Reproduction TestOECD 220
Lemna sp. Growth Inhabition TestOECD 221
Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)OECD 222
Avian Acute Oral Toxicity TestOECD 223
Determination of the Inhibition of the Activity of Anaerobic BacteriaOECD 224
Sediment-Water Lumbriculus Toxicity Test Using Spiked SedimentOECD 225
Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soilOECD 226
Terrestrial Plant Test: Vegetative Vigour TestOECD 227
Determination of Developmental Toxicity of a Test Chemical to Dipteran Dung Flies(Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae))OECD 228
Fish Short Term Reproduction AssayOECD 229; OCSPP 890.1350
21-day Fish AssayOECD 230
Amphibian Metamorphosis AssayOECD 231; OCSPP 890.1100
Collembolan Reproduction Test in SoilOECD 232
Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked SedimentOECD 233
Fish Sexual Development TestOECD 234
Chironomus sp., Acute Immobilisation TestOECD 235
Fish Embryo Acute Toxicity (FET) TestOECD 236
Honey Bee (Apis Mellifera) Larval Toxicity Test, Single ExposureOECD 237


Degradation and Accumulation                                                                                  
Test / PrüfungRichtlinie
  
Ready BiodegradabilityOECD 301; OCSPP 835.3110
Inherent Biodegradability: Modified SCAS TestOECD 302A; OCSPP 835.3210
Inherent Biodegradability: Zahn-Wellens/ EVPA TestOECD 302B; OCSPP 835.3200
Inherent Biodegradability: Modified MITI Test (II)OECD 302C
Simulation Test - Aerobic Sewage Treatment -- A: Activated Sludge Units; B: BiofilmsOECD 303; OCSPP 835.3240, 835.3260
Inherent Biodegradability in SoilOECD 304; OCSPP 835.3300
Bioaccumulation in Fish: Aqueous and Dietary ExposureOECD 305; OCSPP 850.1730
Biodegradability in SeawaterOECD 306; OCSPP 835.3160
Aerobic and Anaerobic Transformation in SoilOECD 307; OCSPP 835.4100, 835.4200
Aerobic and Anaerobic Transformation in Aquatic Sediment SystemsOECD 308; OCSPP 835.4300, 835.4400
Aerobic Mineralisation in Surface Water – Simulation Biodegradation TestOECD 309; OCSPP 835.3190
Ready Biodegradability - CO2 in sealed vessels (Headspace Test)OECD 310; OCSPP 835.3140
Anaerobic Biodegradability of Organic Compounds in Digested Sludge: by Measurement of Gas ProductionOECD 311; OCSPP 835.3420
Leaching in Soil ColumnsOECD 312; OCSPP 835.1240
Estimation of Emissions from Preservative - Treated Wood to the EnvironmentOECD 313
Simulation Tests to Assess the Biodegradability of Chemicals Discharged in WastewaterOECD 314; OCSPP 835.3280
Bioaccumulation in Sediment-dwelling Benthic OligochaetesOECD 315
Phototransformation of Chemicals in Water – Direct PhotolysisOECD 316
Bioaccumulation in Terrestrial OligochaetesOECD 317


Health Effects                                                                                                              
Test / PrüfungRichtlinie
  
Acute Oral ToxicityOECD 401; OCSPP 870.1100
Acute Dermal ToxicityOECD 402; OCSPP 870.1200
Acute Inhalation ToxicityOECD 403; OCSPP 870.1300
Acute Dermal Irritation/CorrosionOECD 404; OCSPP 870.2500
Acute Eye Irritation/CorrosionOECD 405; OCSPP 870.2400
Skin SensitisationOECD 406; OCSPP 870.2600
Repeated Dose 28-day Oral Toxicity Study in RodentsOECD 407; OCSPP 870.3050
Repeated Dose 90-Day Oral Toxicity Study in RodentsOECD 408; OCSPP 870.3100
Repeated Dose 90-Day Oral Toxicity Study in Non-RodentsOECD 409; OCSPP 870.3150
Repeated Dose Dermal Toxicity: 21/28-day StudyOECD 410; OCSPP 870.3200
Subchronic Dermal Toxicity: 90-day StudyOECD 411; OCSPP 870.3250
Subacute Inhalation Toxicity: 28-Day StudyOECD 412
Subchronic Inhalation Toxicity: 90-day StudyOECD 413; OCSPP 870.3465
Prenatal Development Toxicity StudyOECD 414; OCSPP 870.3700
One-Generation Reproduction Toxicity StudyOECD 415
Two-Generation Reproduction ToxicityOECD 416; OCSPP 870.3800
ToxicokineticsOECD 417; OCSPP 870.7485
Delayed Neurotoxicity of Organophosphorus Substances Following Acute ExposureOECD 418; OCSPP 870.6100
Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose StudyOECD 419; OCSPP 870.6100
Acute Oral Toxicity - Fixed Dose ProcedureOECD 420; OCSPP 870.1100
Reproduction/Developmental Toxicity Screening TestOECD 421; OCSPP 870.3550
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening TestOECD 422; OCSPP 870.3650
Acute Oral toxicity - Acute Toxic Class MethodOECD 423; OCSPP 870.1100
Neurotoxicity Study in RodentsOECD 424; OCSPP 870.6200
Acute Oral Toxicity: Up-and-Down ProcedureOECD 425; OCSPP 870.1100
Developmental Neurotoxicity StudyOECD 426
Skin Absorption: In Vivo MethodOECD 427
Skin Absorption: In Vitro MethodOECD 428
Skin SensitisationOECD 429
In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)OECD 430
In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test MethodOECD 431
In Vitro 3T3 NRU Phototoxicity TestOECD 432
In Vitro Membrane Barrier Test Method for Skin CorrosionOECD 435
Acute Inhalation Toxicity – Acute Toxic Class MethodOECD 436
Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye DamageOECD 437
Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye DamageOECD 438
In Vitro Skin Irritation - Reconstructed Human Epidermis Test MethodOECD 439
Uterotrophic Bioassay in RodentsOECD 440; OCSPP 890.1600
Hershberger Bioassay in RatsOECD 441; OCSPP 890.1400
Skin SensitizationOECD 442A
Skin SensitizationOECD 442B
Extended One-Generation Reproductive Toxicity StudyOECD 443
Carcinogenicity StudiesOECD 451; OCSPP 870.4200
Chronic Toxicity StudiesOECD 452; OCSPP 870.4100
Combined Chronic Toxicity/Carcinogenicity StudiesOECD 453; OCSPP 870.4300
Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor AgonistsOECD 455; OCSPP 890.1300, 890.1550
H295R Steroidogenesis AssayOECD 456
BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and AntagonistsOECD 457
Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe IrritantsOECD 460
Bacterial Reverse Mutation TestOECD 471; OCSPP 870.5100; ISO 10993-3, 10993-12
In vitro Mammalian Chromosome Aberration TestOECD 473; OCSPP 870.5375; ISO 10993-3, 10993-12
Mammalian Erythrocyte Micronucleus TestOECD 474; OCSPP 870.5395; ISO 10993-3, 10993-12
Mammalian Bone Marrow Chromosome Aberration TestOECD 475; OCSPP 870.5385
In vitro Mammalian Cell Gene Mutation TestOECD 476; OCSPP 870.5300; ISO 10993-3, 10993-12
Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogasterOECD 477; OCSPP 870.5275
Genetic Toxicology: Rodent Dominant Lethal TestOECD 478; OCSPP 870.5450
Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian CellsOECD 479; OCSPP 870.5900
Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation AssayOECD 480
Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination AssayOECD 481; OCSPP 870.5575
Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitroOECD 482; OCSPP 870.5550
Mammalian Spermatogonial Chromosome Aberration TestOECD 483; OCSPP 870.5380
Genetic Toxicology: Mouse Spot TestOECD 484
Genetic toxicology, Mouse Heritable Translocation AssayOECD 485; OCSPP 870.5460
Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivoOECD 486; ISO 10993-3, 10993-12
In Vitro Mammalian Cell Micronucleus TestOECD 487; ISO 10993-3, 10993-12
Transgenic Rodent Somatic and Germ Cell Gene Mutation AssaysOECD 488


Other Test Guidelines                                                                                                
Test / PrüfungRichtlinie
  
Metabolism in CropsOECD 501
Metabolism in Rotational CropsOECD 502
Metabolism in LivestockOECD 503
Residues in Rotational Crops (Limited Field Studies)OECD 504
Residues in LivestockOECD 505
Stability of Pesticide Residues in Stored CommoditiesOECD 506
Nature of the Pesticide Residues in Processed Commodities - High Temperature HydrolysisOECD 507
Magnitude of the Pesticide Residues in Processed CommoditiesOECD 508
Crop Field TrialOECD 509

 


Testung auf endokrine Eigenschaften nach OECD

Die endokrinen Disruptoren (endokrin aktive Substanzen EAS) sind in den letzten Jahren immer mehr in den Fokus der Öffentlichkeit geraten, da sie durch ihre hormonähnliche Wirkung schon in den niedrigsten Konzentrationen Auswirkungen auf die Organismen in der Umwelt zeigen.

2002 wurde von der EDTA (OECD Endocrine Disrupter Testing and Assessment Task Force) das ,,OECD Conceptual Framework for the Testing and Assessment of Endocrine Disrupting Chemicals“ eingeführt, welches fünf verschiedene Untersuchungsstufen für die Risikobewertung für diese  Substanzen vorgibt:

Level 1
Analyse der existierenden Daten

Level 2
Untersuchung eines einzelnen endokrinen Mechanismus durch in vitro Studien

Level 3
Untersuchung eines einzelnen endokrinen Mechanismus durch in vivo Studien

Level 4
Untersuchung von multiplen endokrinen Mechanismen durch in vivo Studien

Level 5
In vivo Langzeitstudien

Wir unterstützen Sie bei der Testung von endokrin wirksamen Substanzen mit folgenden Studien:

Level 2

  • Östrogen- und Androgen Rezeptorbindungsaffinität (YES/YAS Assay)

Level 4

  • Fish Sexual Development Test (OECD 234)

  • Fish Reproduction Partial Lifecycle Test

  • Sediment-Water Chironomid Toxicity Using Spiked Sediment (OECD 218)

  • Sediment-Water Chironomid Toxicity Using Spiked Water (OECD 219)

  • Daphnia Reproduction Test (OECD 211)

  • Earthworm Reproduction Test (OECD 222)

  • Sediment Water Lumbriculus Toxicity Test (OECD 225)

Level 5

  • Fish Life Cycle Test (Danio rerio) (OECD DRP 2008)


UN-Methoden

Wir bieten Ihnen die UN-Methoden, welche im Rahmen der CLP-Verordnung (EG) Nr. 1272/2008 und des Global Harmonisierten Systems (GHS) für die Kennzeichnung und Einstufung sowie für den Transport von Gefahrstoffen gefordert werden.

NormBeschreibung
H.4Heat accumulation storage test (Chapter 28.4.4)*
N.1Test method for readily combustible solids (Chapter 33.2)*
N.2Test method for pyrophoric solids (Chapter 33.3)*
N.3Test method for pyrophoric liquids (Chapter 33.3)*
N.4Test method for self-heating substances (Chapter 33.3)*
N.5Test method for substances which in contact with water emit flammable gases (Chapter 33.4)*
O.1Test for oxidizing solids (Chapter 34.4)*
O.2Test for oxidizing liquids (Chapter 34.4)*
C.1Metal Corrosivity (Chapter 37.4)*

*UN Recommendations on the Transport of Dangerous Goods. Manual of Tests and Criteria (Fifth revised ed.), New York and Geneva: United Nations, 2009, ISBN 978-92-1-139135-0, ST/SG/AC.10/11/Rev.5


CIPAC-Methoden

Die CIPAC-Methoden (Collaborative International Pesticides Analytical Council) spielen besonders für die Registrierung und Zulassung von Pflanzenschutzmitteln eine wichtige Rolle und sind international anerkannt. Je nach Formulierung Ihres Produktes können wir die entsprechend geforderten Prüfmethoden für Sie durchführen.

NormBeschreibung
CIPAC MT 3Specific gravity, density and weight per millilitre
CIPAC MT 15Suspensibility of wettable powders in water
CIPAC MT 20Stability of dilute emulsion
CIPAC MT 22Viscosity
CIPAC MT 32Determination of conductivity
CIPAC MT 33Tap density
CIPAC MT 34Dustability tests after tropical storage
CIPAC MT 36Emulsion characteristics of emulsifiable concentrates
CIPAC MT 39Stability of liquid formulations at 0°C
CIPAC MT 41Dilution stability of herbicide aqueous solutions
CIPAC MT 44Flow number
CIPAC MT 46Accelerated storage procedure
CIPAC MT 47Persistent foaming
CIPAC MT 53Wettability
CIPAC MT 58Dust content and apparent density of granular pesticide formulations
CIPAC MT 59Sieve analysis
CIPAC MT 75Determination of pH values
CIPAC MT 148Pourability of suspension concentrates
CIPAC MT 159Pour and tap bulk density of granular materials
CIPAC MT 160Spontaneity of dispersion of suspension concentrates
CIPAC MT 161Suspensibility of aqueous suspension concentrates
CIPAC MT 167Wet sieving after dispersion of water dispersible granules
CIPAC MT 169Tap density of water dispersible granules
CIPAC MT 171Dustiness of granular products
CIPAC MT 172Flowability of water dispersible granules after heat test under pressure
CIPAC MT 174Dispersibility of water dispersible granules
CIPAC MT 176Dissolution rate of water soluble bags
CIPAC MT 179Dissolution degree and solution stability
CIPAC MT 180Dispersion stability of suspo-emulsions
CIPAC MT 184Suspensibility of formulations forming suspensions on dilution with water
CIPAC MT 185Wet sieve test
CIPAC MT 186Bulk density
CIPAC MT 191Acidity or alkalinity of formulations

OECD-Testmethoden für regulatorische Zwecke

Section 1: Physical Chemical Properties
Section 2: Effects on Biotic Systems
Section 3: Degradation and Accumulation
Section 4: Health Effects
Section 5: Other Test Guidelines


In-vitro- Testmethoden für regulatorische Zwecke 

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