Chemicals

Required Test Items According to the Annual Manufacturing or Import Tonnage of Chemicals

Category Test Item 0.1 - 1 ton 1 - 10 tons 10 - 100 tons 100 - 1,000 tons ≥1,000 tons Study Plan Submission Allowed
General Polymer Transported Isolated Intermediate General Polymer Transported Isolated Intermediate General Polymer Transported Isolated Intermediate General Polymer Transported Isolated Intermediate General Polymer Transported Isolated Intermediate
Physicochemical Properties (Non-GLP) Physical State ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Water Solubility ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Melting Point/Freezing Point ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Boiling Point ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Vapor Pressure ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Octanol/Water Partition Coefficient (GLP) ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Density ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Particle Size Analysis ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Flammability ○ ○ ○ ○ ○ ○ ○
Explosiveness ○ ○ ○ ○ ○ ○ ○
Oxidizing Properties ○ ○ ○ ○ ○ ○ ○
Viscosity ○ ○ ○ ○ ○
Dissociation Constant ○ ○ ○ ○ ○
Human Hazard Assessment (GLP) Acute Oral Toxicity ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Reverse Mutation * ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Skin Irritation/Corrosion ○ ○ ○ ○ ○ ○ ○
Skin Sensitization ○ ○ ○ ○ ○ ○ ○
Acute Dermal Toxicity ** ○ ○ ○ ○
Acute Inhalation Toxicity ** ○ ○ ○ ○ ○
Eye Irritation/Corrosion ○ ○ ○ ○
In Vitro Mammalian Cell Chromosomal Aberration Test ○ ○ ○ ○
In Vivo Genotoxicity Test ○ ○ ○ ○
Repeated-Dose Toxicity (28-Day) ○ ○ ○ ○
Reproductive and Developmental Toxicity Screening ○ ○ ○ ○ ○
Additional Genotoxicity (e.g., Germ Cell Genotoxicity) ○ ○ ○
Repeated-Dose Toxicity (90-Day) ○ ○
Teratogenicity ○ ○
Two-Generation Reproductive Toxicity ○ ○
Carcinogenicity ○ ○
Environmental Hazard Assessment
(GLP)
Fish Acute Toxicity ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Ready Biodegradability ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
Daphnia Acute Toxicity ○ ○ ○ ○ ○ ○ ○
Freshwater Algal Growth Inhibition ○ ○ ○ ○
Hydrolysis as a Function of pH (Non-GLP) ○ ○ ○ ○
Inherent Biodegradability ○ ○ ○
Identification of Degradation Products ○ ○ ○
Fish Chronic Toxicity ○ ○ ○
Daphnia Chronic Toxicity ○ ○ ○
Terrestrial Plant Acute Toxicity ○ ○ ○
Terrestrial Invertebrate Acute Toxicity ○ ○ ○
Activated Sludge Respiration Inhibition ○ ○ ○
Adsorption and Desorption ○ ○ ○
Additional Information on Environmental Fate and Behavior ○ ○
Terrestrial Plant Chronic Toxicity ○ ○
Terrestrial Invertebrate Chronic Toxicity ○ ○
Additional Information on Adsorption and Desorption ○ ○
Sediment-Dwelling Organism Chronic Toxicity ○ ○
Bioaccumulation Potential ○ ○
* : If the result of the reverse mutation test is positive, an in vitro mammalian chromosomal aberration test and an in vivo genotoxicity test are required.
If the results of both the reverse mutation test and the in vitro mammalian chromosomal aberration test are negative, data from an in vitro mammalian cell gene mutation test may be submitted instead.
** : For chemicals to which humans are exposed through only one exposure route, test data for either acute dermal toxicity or acute inhalation toxicity may be submitted for that single exposure route only.