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. 2016 Dec 19;31:e2016026. doi: 10.5620/eht.e2016026

Table 1.

Requirement of data for Act on the Registration and Evaluation of Chemicals registration

Field Tonnage [no. of test]a
≥1-10< [15] ≥10-100< [26] ≥100-1000 < [37] ≥1000 [47]
Physicochemical property State of substance Flammability Viscosity
Water sdubility Explosiveness Dissociation constant
Melting/freezing point Oxidation
Boiling point
Vapor pressure
Octanol/water partitioning coefficient
Density
Particle size analysis
Hazard on human health Acute toxicity-oral (acute toxicity-inhalation) Acute toxicity-dermal route or inhalation Additional genotoxicity test (reproductive cell and genotoxicity) Repeated dose toxicity study (90 d)
Teratogenicity
Ames test (bacterial reverse mutation assay) Eye irritation/corrosion Two-generation reproductive toxicity
Chromosomal aberration test Carcinogenicity
Skin irritation/corrosion Genotoxicity test
Skin sensitization Repeated dose toxicity study (28 d)
Screening for reproductive/ developmental toxicity
Hazard on the environment Acute toxicity on fish Fresh water algae growth inhibition test Inherent biodegradability Further information on the environmental fate and behavior
Ready biodegradability Identification of degradation products
Acute daphnia immobilization test Biodegradation as a function of pH Chronic toxicity on fish Chronic toxicity on terrestrial plants
Chronic toxicity on preferred species daphnia Chronic toxicity testing on terrestrial invertebrates
Acute toxicity on terrestrial plants Further information on adsorption/ desorption depending on the results of the study
Activated sludge respiration inhibition Adsorption/desorption
Long-term toxicity to sediment organisms
Bio-concentration
a

Test items for lower tonnage are also required.