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


*Some of the data points can be replaced by testing plans.