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

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

2: Auswirkungen auf biologische Systeme

Nummer Titel (engl.)
201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test
202 Daphnia sp. Acute Immobilisation Test
203 Fish, Acute Toxicity Test
204 Fish, Prolonged Toxicity Test: 14-Day Study
205 Avian Dietary Toxicity Test
206 Avian Reproduction Test
207 Earthworm, Acute Toxicity Tests
208 Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test
209 Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)
210 Fish, Early-life Stage Toxicity Test
211 Daphnia magna Reproduction Test
212 Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages
213 Honeybees, Acute Oral Toxicity Test
214 Honeybees, Acute Contact Toxicity Test
215 Fish, Juvenile Growth Test
216 Soil Microorganisms: Nitrogen Transformation Test
217 Soil Microorganisms: Carbon Transformation Test
218 Sediment-Water Chironomid Toxicity Using Spiked Sediment
219 Sediment-Water Chironomid Toxicity Using Spiked Water
220 Enchytraeid Reproduction Test
221 Lemna sp. Growth Inhibition Test
222 Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
223 Avian Acute Oral Toxicity Test
224 Determination of the Inhibition of the Activity of Anaerobic Bacteria
225 Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment
226 Predatory mite (Hypoaspis aculeifer) reproduction test in soil
227 Terrestrial Plant Test: Vegetative Vigour Test
228 Determination of Developmental Toxicity of a Test Chemical to Dipteran Dung Flies (Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae))
229 Fish Short Term Reproduction Assay
230 21-day Fish Assay
231 Amphibian Metamorphosis Assay
232 Collembolan Reproduction Test in Soil
233 Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment
234 Fish Sexual Development Test
235 Chironomus sp., Acute Immobilisation Test
236 Fish Embryo Acute Toxicity (FET) Test
237 Honey Bee (Apis mellifera) Larval Toxicity Test, Single Exposure
238 Sediment-Free Myriophyllum spicatum Toxicity Test
239 Water-Sediment Myriophyllum spicatum Toxicity Test
240 Medaka Extended One Generation Reproduction Test (MEOGRT)
241 The Larval Amphibian Growth and Development Assay (LAGDA)
242 Potamopyrgus antipodarum Reproduction Test
243 Lymnaea stagnalis Reproduction Test
244 Protozoan Activated Sludge Inhibition Test
245 Honey Bee (Apis mellifera L.), Chronic Oral Toxicity Test (10-Day Feeding)
246 Bumblebee, Acute Contact Toxicity Test
247 Bumblebee, Acute Oral Toxicity Test
248 Xenopus Eleutheroembryonic Thyroid Assay (XETA)
249 Fish Cell Line Acute Toxicity – The RTgill-W1 cell line assay
250 EASZY assay – Detection of Endocrine Active Substances, acting through estrogen receptors, using transgenic tg(cyp19a1b:GFP) Zebrafish embrYos

3: Abbau und Anreicherung

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

4: Auswirkungen auf die Gesundheit

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

5: Übrige Richtlinien

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

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