OECD-Richtlinien zur Prüfung von Chemikalien

Die OECD-Richtlinien zur Prüfung von Chemikalien sind von der OECD entwickelte Prüfmethoden, die der Ermittlung und Charakterisierung potentieller Gefahrenquellen dienen, die von Chemikalien ausgehen. Sie werden von Regulierungsbehörden und Prüflaboren zur Registrierung, Bewertung, Zulassung und Beschränkung von bekannten und neu entwickelten Chemikalien eingesetzt. OECD-Mitgliedstaaten setzen die Richtlinien in nationales Recht um. In der Europäischen Union basiert die REACH-Verordnung auf den OECD-Richtlinien. Die OECD-Richtlinien werden bei Bedarf an den Stand der Technik angepasst.

Bereiche

Die OECD-Richtlinien sind in fünf Bereiche unterteilt:

  • 1: Physikochemische Eigenschaften
  • 2: Auswirkungen auf biologische Systeme
  • 3: Abbau und Anreicherung
  • 4: Auswirkungen auf die Gesundheit
  • 5: Übrige Richtlinien

Die Richtlinien haben dreistellige Nummern, wovon sich die erste Stelle auf den Bereich bezieht. Bei einigen ist am Ende zusätzlich ein Buchstabe angegeben.

1: Physikochemische Eigenschaften

NummerTitel (engl.)
101UV-VIS Absorption Spectra
102Melting Point/Melting Range
103Boiling Point
104Vapour Pressure
105Water Solubility
106Adsorption – Desorption Using a Batch Equilibrium Method
107Partition Coefficient (n-octanol/water): Shake Flask Method
108Complex Formation Ability in Water
109Density of Liquids and Solids
110Particle Size Distribution/ Fibre Length and Diameter Distributions
111Hydrolysis as a Function of pH
112Dissociation Constants in Water
113Screening Test for Thermal Stability and Stability in Air
114Viscosity of Liquids
115Surface Tension of Aqueous Solutions
116Fat Solubility of Solid and Liquid Substances
117Partition Coefficient (n-octanol/water), HPLC Method
118Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography
119Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography
120Solution/Extraction Behaviour of Polymers in Water
121Estimation of the Adsorption Coefficient (KOC) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)
122Determination of pH, Acidity and Alkalinity
123Partition Coefficient (1-Octanol/Water): Slow-Stirring Method

2: Auswirkungen auf biologische Systeme

NummerTitel (engl.)
201Freshwater Alga and Cyanobacteria, Growth Inhibition Test
202Daphnia sp. Acute Immobilisation Test
203Fish, Acute Toxicity Test
204Fish, Prolonged Toxicity Test: 14-Day Study
205Avian Dietary Toxicity Test
206Avian Reproduction Test
207Earthworm, Acute Toxicity Tests
208Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test
209Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)
210Fish, Early-life Stage Toxicity Test
211Daphnia magna Reproduction Test
212Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages
213Honeybees, Acute Oral Toxicity Test
214Honeybees, Acute Contact Toxicity Test
215Fish, Juvenile Growth Test
216Soil Microorganisms: Nitrogen Transformation Test
217Soil Microorganisms: Carbon Transformation Test
218Sediment-Water Chironomid Toxicity Using Spiked Sediment
219Sediment-Water Chironomid Toxicity Using Spiked Water
220Enchytraeid Reproduction Test
221Lemna sp. Growth Inhibition Test
222Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
223Avian Acute Oral Toxicity Test
224Determination of the Inhibition of the Activity of Anaerobic Bacteria
225Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment
226Predatory mite (Hypoaspis aculeifer) reproduction test in soil
227Terrestrial Plant Test: Vegetative Vigour Test
228Determination of Developmental Toxicity of a Test Chemical to Dipteran Dung Flies (Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae))
229Fish Short Term Reproduction Assay
23021-day Fish Assay
231Amphibian Metamorphosis Assay
232Collembolan Reproduction Test in Soil
233Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment
234Fish Sexual Development Test
235Chironomus sp., Acute Immobilisation Test
236Fish Embryo Acute Toxicity (FET) Test
237Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure
238Sediment-Free Myriophyllum spicatum Toxicity Test
239Water-Sediment Myriophyllum spicatum Toxicity Test
240Medaka Extended One Generation Reproduction Test (MEOGRT)
241The Larval Amphibian Growth and Development Assay (LAGDA)
242Potamopyrgus antipodarum Reproduction Test
243Lymnaea stagnalis Reproduction Test
244Protozoan Activated Sludge Inhibition Test
245Honey Bee (Apis mellifera L.), Chronic Oral Toxicity Test (10-Day Feeding)
246Bumblebee, Acute Contact Toxicity Test
247Bumblebee, Acute Oral Toxicity Test
248Xenopus Eleutheroembryonic Thyroid Assay (XETA)
249Fish Cell Line Acute Toxicity – The RTgill-W1 cell line assay
250EASZY assay – Detection of Endocrine Active Substances, acting through estrogen receptors, using transgenic tg(cyp19a1b:GFP) Zebrafish embrYos

3: Abbau und Anreicherung

NummerTitel (engl.)
301Ready Biodegradability
302AInherent Biodegradability: Modified SCAS Test
302BInherent Biodegradability: Zahn-Wellens / EVPA Test
302CInherent Biodegradability: Modified MITI Test (II)
303Simulation Test – Aerobic Sewage Treatment – A: Activated Sludge Units; B: Biofilms
304AInherent Biodegradability in Soil
305Bioaccumulation in Fish: Aqueous and Dietary Exposure
306Biodegradability in Seawater
307Aerobic and Anaerobic Transformation in Soil
308Aerobic and Anaerobic Transformation in Aquatic Sediment Systems
309Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test
310Ready Biodegradability – CO2 in sealed vessels (Headspace Test)
311Anaerobic Biodegradability of Organic Compounds in Digested Sludge: by Measurement of Gas Production
312Leaching in Soil Columns
313Estimation of Emissions from Preservative – Treated Wood to the Environment
314Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater
315Bioaccumulation in Sediment-dwelling Benthic Oligochaetes
316Phototransformation of Chemicals in Water – Direct Photolysis
317Bioaccumulation in Terrestrial Oligochaetes
318Dispersion Stability of Nanomaterials in Simulated Environmental Media
319ADetermination of in vitro intrinsic clearance using cryopreserved rainbow trout hepatocytes (RT-HEP)
319BDetermination of in vitro intrinsic clearance using rainbow trout liver S9 sub-cellular fraction (RT-S9)

4: Auswirkungen auf die Gesundheit

NummerTitel (engl.)
401Acute Oral Toxicity
402Acute Dermal Toxicity
403Acute Inhalation Toxicity
404Acute Dermal Irritation/Corrosion
405Acute Eye Irritation/Corrosion
406Skin Sensitisation
407Repeated Dose 28-day Oral Toxicity Study in Rodents
408Repeated Dose 90-Day Oral Toxicity Study in Rodents
409Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents
410Repeated Dose Dermal Toxicity: 21/28-day Study
411Subchronic Dermal Toxicity: 90-day Study
412Subacute Inhalation Toxicity: 28-Day Study
413Subchronic Inhalation Toxicity: 90-day Study
414Prenatal Development Toxicity Study
415One-Generation Reproduction Toxicity Study
416Two-Generation Reproduction Toxicity
417Toxicokinetics
418Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure
419Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study
420Acute Oral Toxicity – Fixed Dose Procedure
421Reproduction/Developmental Toxicity Screening Test
422Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
423Acute Oral toxicity – Acute Toxic Class Method
424Neurotoxicity Study in Rodents
425Acute Oral Toxicity: Up-and-Down Procedure
426Developmental Neurotoxicity Study
427Skin Absorption: In Vivo Method
428Skin Absorption: In Vitro Method
429Skin Sensitisation
430In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)
431In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method
432In Vitro 3T3 NRU Phototoxicity Test
435In Vitro Membrane Barrier Test Method for Skin Corrosion
436Acute Inhalation Toxicity – Acute Toxic Class Method
437Bovine 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 Damage
438Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
439In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
440Uterotrophic Bioassay in Rodents
441Hershberger Bioassay in Rats
442ASkin Sensitization
442BSkin Sensitization
442CIn Chemico Skin Sensitisation
442DIn Vitro Skin Sensitisation
443Extended One-Generation Reproductive Toxicity Study
451Carcinogenicity Studies
452Chronic Toxicity Studies
453Combined Chronic Toxicity/Carcinogenicity Studies
455Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
456H295R Steroidogenesis Assay
457BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists
460Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants
471Bacterial Reverse Mutation Test
473In Vitro Mammalian Chromosomal Aberration Test
474Mammalian Erythrocyte Micronucleus Test
475Mammalian Bone Marrow Chromosomal Aberration Test
476In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes
477Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster
478Rodent Dominant Lethal Test
479Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells
480Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay
481Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay
482Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro
483Mammalian Spermatogonial Chromosomal Aberration Test
484Genetic Toxicology: Mouse Spot Test
485Genetic toxicology, Mouse Heritable Translocation Assay
486Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo
487In Vitro Mammalian Cell Micronucleus Test
488Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays
489In Vivo Mammalian Alkaline Comet Assay
490In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene
491Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
492Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage
493Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity
494Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
495Ros (Reactive Oxygen Species) Assay for Photoreactivity
496In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
497Defined Approaches on Skin Sensitisation
498In vitro Phototoxicity – Reconstructed Human Epidermis Phototoxicity test method

5: Übrige Richtlinien

NummerTitel (engl.)
501Metabolism in Crops
502Metabolism in Rotational Crops
503Metabolism in Livestock
504Residues in Rotational Crops (Limited Field Studies)
505Residues in Livestock
506Stability of Pesticide Residues in Stored Commodities
507Nature of the Pesticide Residues in Processed Commodities – High Temperature Hydrolysis
508Magnitude of the Pesticide Residues in Processed Commodities
509Crop Field Trial

Quellen