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REACH Documents: Annex V to Directive 67/548/EEC
Methods for the Determination of Physico-Chemical Properties, Toxicity and Ecotoxicity.
Last update: 10 June 2004
Please notice that only European legislation published in the paper editions of the Official Journal of the European Communities is deemed authentic.
List of Official Journal references in which to find the methods described in this section.
INTRODUCTION
The Annex sets out test methods for the determination of physicochemical, toxicological and ecotoxicological properties listed in Annexes VII and VIII to Directive 79/831/EEC. The methods are based on those recognized and recommended by competent international bodies (in particular OECD).

When such methods were not available, national standards or scientific consensus methods have been adopted. Generally, tests should be performed with the substance as defined by the Directive. Attention should be given to the possible influence of impurities on the test results.

When the methods of this Annex are inappropriate for the investigation of a certain property, the notifier must justify the alternate method used.

Animal tests and studies shall be conducted in accordance with national regulations and shall take into account humane principles and international developments in the field of animal welfare.

Among equivalent testing methods, the method using the minimum number of animals is chosen.

Part A: Methods for the determination of the physico-chemical properties

  A.1 MELTING/FREEZING TEMPERATURE
A.2 BOILING TEMPERATURE
A.3 RELATIVE DENSITY
A.4 VAPOUR PRESSURE
A.5 SURFACE TENSION
A.6 WATER SOLUBILITY
A.8 PARTITION COEFFICIENT
A.9 FLASH-POINT
A.10 FLAMMABILITY (SOLIDS)
A.11 FLAMMABILITY (GASES)
A.12 FLAMMABILITY (CONTACT WITH WATER)
A.13 PYROPHORIC PROPERTIES OF SOLIDS AND LIQUIDS
A.14 EXPLOSIVE PROPERTIES
A.15 AUTO-IGNITION TEMPERATURE (LIQUIDS AND GASES)
A.16 RELATIVE SELF-IGNITION TEMPERATURE FOR SOLIDS
A.17 OXIDIZING PROPERTIES (SOLIDS)
A.18 NUMBER - AVERAGE MOLECULAR WEIGHT AND MOLECULAR WEIGHT DISTRIBUTION OF POLYMERS
A.19 LOW MOLECULAR WEIGHT CONTENT OF POLYMERS
A.20 SOLUTION / EXTRACTION BEHAVIOUR OF POLYMERS IN WATER
A.21 OXIDISING PROPERTIES (LIQUIDS)

Part B: Methods for the determination of toxicity

  GENERAL INTRODUCTION
B.1bis ACUTE ORAL TOXICITY - FIXED DOSE PROCEDURE
B.1tris ACUTE ORAL TOXICITY - ACUTE TOXIC CLASS METHOD
B.2 ACUTE TOXICITY (INHALATION)
B.3 ACUTE TOXICITY (DERMAL)
B.4 ACUTE TOXICITY: DERMAL IRRITATION/CORROSION
B.5 ACUTE TOXICITY: EYE IRRITATION/CORROSION
B.6 SKIN SENSITISATION
B.7 REPEATED DOSE (28 DAYS) TOXICITY (ORAL)
B.8 REPEATED DOSE (28 DAYS) TOXICITY (INHALATION)
B.9 REPEATED DOSE (28 DAYS) TOXICITY (DERMAL)
B.10 MUTAGENICITY - IN VITRO MAMMALIAN CHROMOSOME ABERRATION TEST)
B.11 MUTAGENICITY - IN VIVO MAMMALIAN BONE-MARROW CHROMOSOME ABERRATION TEST
B.12 MUTAGENICITY MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST
B.13/14 MUTAGENICITY - REVERSE MUTATION TEST USING BACTERIA
B.15 GENE MUTATION - SACCHAROMYCES CEREVISAE
B.16 MITOTIC RECOMBINATION - SACCHAROMYCES CEREVISAE
B.17 MUTAGENICITY - IN VITRO MAMMALIAN CELL GENE MUTATION TEST
B.18 DNA DAMAGE AND REPAIR - UNSCHEDULED DNA SYNTHESIS - MAMMALIAN CELLS IN VITRO
B.19 SISTER CHROMATID EXCHANGE ASSAY IN VITRO
B.20 SEX-LINKED RECESSIVE LETHAL TEST IN DROSOPHILA MELANOGASTER
B.21 IN VITRO MAMMALIAN CELL TRANSFORMATION TEST
B.22 RODENT DOMINANT LETHAL TEST
B.23 MAMMALIAN SPERMATOGONIAL CHROMOSOME ABERRATION TEST
B.24 MOUSE SPOT TEST
B.25 MOUSE HERITABLE TRANSLOCATION
B.26 SUB-CHRONIC ORAL TOXICITY TEST. REPEATED DOSE 90 - DAY TOXICITY STUDY IN RODENTS
B.27 SUB-CHRONIC ORAL TOXICITY TEST: REPEATED DOSE 90 - DAY TOXICITY STUDY IN NON-RODENTS
B.28 SUB-CHRONIC DERMAL TOXICITY TEST: 90-DAY REPEATED DERMAL DOSE STUDY USING RODENT SPECIES
B.29 SUB-CHRONIC INHALATION TOXICITY TEST: 90-DAY REPEATED INHALATION DOSE STUDY USING RODENT SPECIES
B.30 CHRONIC TOXICITY TEST
B.31 TERATOGENICITY TEST RODENT AND NON-RODENT
B.32 CARCINOGENICITY TEST
B.33 COMBINED CHRONIC TOXICITY/CARCINOGENICITY TEST
B.34 ONE-GENERATION REPRODUCTION TOXICITY TEST
B.35 TWO GENERATION REPRODUCTION TOXICITY TEST
B.36 TOXICOKINETICS
B.37 DELAYED NEUROTOXICITY OF ORGANOPHOSPHORUS SUBSTANCES FOLLOWING ACUTE EXPOSURE
B.38 DELAYED NEUROTOXICITY OF ORGANOPHOSPHORUS SUBSTANCES 28 DAY REPEATED DOSE STUDY
B.39 UNSCHEDULED DNA SYNTHESIS (UDS) TEST WITH MAMMALIAN LIVER CELLS IN VIVO
B.40 SKIN CORROSION (IN VITRO)
B.41 PHOTOTOXICITY - IN VITRO 3T3 NRU PHOTOTOXICITY TEST
B.42 SKIN SENSITISATION: LOCAL LYMPH NODE ASSAY
B.43 NEUROTOXICITY STUDY IN RODENTS

Part C: Methods for the determination of ecotoxicity

  GENERAL INTRODUCTION
C.1 ACUTE TOXICITY FOR FISH
C.2 ACUTE TOXICITY FOR DAPHNIA
C.3 ALGAL INHIBITION TEST
C.4 BIODEGRADATION: DETERMINATION OF THE "READY" BIODEGRADABILITY
  C.4-A DISSOLVED ORGANIC CARBON (DOC) DIE-AWAY TEST
C.4-B MODIFIED OECD SCREENING TEST
C.4-C CARBON DIOXIDE EVOLUTION TEST
C.4-D MANOMETRIC RESPIROMETRY TEST
C.4-E CLOSED BOTTLE TEST
C.4-F MITI TEST
C.5 DEGRADATION : BIOCHEMICAL OXYGEN DEMAND
C.6 DEGRADATION: CHEMICAL OXYGEN DEMAND
C.7 DEGRADATION: ABIOTIC DEGRADATION: HYDROLYSIS AS A FUNCTION OF PH
C.8 TOXICITY FOR EARTHWORMS : ARTIFICIAL SOIL TEST
C.9 BIODEGRADATION: ZAHN - WELLENS TEST
C.10 BIODEGRADATION: ACTIVATED SLUDGE SIMULATION TEST
C.11 BIODEGRADATION: ACTIVATED SLUDGE RESPIRATION INHIBITION TEST
C.12 BIODEGRADATION: MODIFIED SCAS TEST
C.13 BIOCONCENTRATION: FLOW-THROUGH FISH TEST
C.14 FISH JUVENILE GROWTH TEST
C.15 FISH, SHORT-TERM TOXICITY TEST ON EMBRYO AND SAC-FRY STAGES
C.16 HONEYBEES - ACUTE ORAL TOXICITY TEST
C.17 HONEYBEES - ACUTE CONTACT TOXICITY TEST
C.18 ADSORPTION/DESORPTION USING A BATCH EQUILIBRIUM METHOD
C.19 ESTIMATION OF THE ADSORPTION COEFFICIENT (KOC) ON SOIL AND ON SEWAGE SLUDGE USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)
C.20 DAPHNIA MAGNA REPRODUCTION TEST
C.21 SOIL MICROORGANISMS: NITROGEN TRANSFORMATION TEST
C.22 SOIL MICROORGANISMS: CARBON TRANSFORMATION TEST
C.23 AEROBIC AND ANAEROBIC TRANSFORMATION IN SOIL
C.24 AEROBIC AND ANAEROBIC TRANSFORMATION IN AQUATIC SEDIMENT SYSTEMS

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