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Registration
Registration of new substance is required prior to manufacturing and importation for substance with quantity larger than 1 t/y.
The data points required for new substance registration will depend on the annual tonnage.
- 1 ~ 10 t/y: 15 data points;
- 10 ~ 100 t/y: 26 data points;
- 100 ~1000 t/y: 37 data points;
- 1000+ t/y: 47 data points.
The table below shows the data requirement details for each tonnage level:
| Tonnage level | Physicochemical | Toxicological | Eco-Toxicological |
|
1 ~ 10 t/y |
- Physical status - Water solubility - Melting /Freezing point - Boiling point - Vapor pressure - Octanol/Water partition coefficient - Density - Granulometry |
- Acute oral toxicity - AMES test - Skin irritation/corrosion - Skin sensitization
|
- Acute fish toxicity - Ready biodegradability - Acute daphnia toxicity
|
| 10 ~ 100 t/y |
The above data points plus: - Flammability - Explosive property - Oxidizing property |
The above data points plus: - Acute dermal or inhalation test - Eye irritation/corrosion - In vitro mammalian chromosomal aberration test - In vitro mammalian gene mutation test - Repeated dose test (28-day) - Screening for reproductive/developmental toxicity |
The above data points plus: - Acute algae toxicity - Hydrolysis as a function of pH
|
| 100 ~ 1000 t/y |
The above data points plus: - Viscosity - Dissociation constant |
The above data points plus: - Additional mutation test (germ cell mutagenicity test, etc. ) |
The above data points plus: - Inherent biodegradablity - Identification of degradation products - Chronic fish toxicity - Chronic daphnia toxicity - Short-term toxicity to plants - Short-term toxicity to invertebrates (earthworm) - Activated sludge respiration inhibition test - Adsorption/desorption screening test |
| 1000+ t/y | Same as 100 ~ 1000 t/y |
The above data points plus: - Sub-chronic toxicity test (90-day) - Prenatal developmental toxicity test - Two-generation toxicity test - Carcinogenicity test |
The above data points plus: - Fate and behavior in the environment - Long-term toxicity testing plants - Long-term toxicity testing on invertebrates (earthworm) - Additional adsorption/desorption screening - Long-term toxicity to sediment organisms - Bioaccumulation |
