Information requirements of a chemical substance for registration

 

Just as the registration of a chemical substance under EU REACH, information requirements in Korea are also different depending on the annual manufacture/import tons of a chemical substance. Details are prescribed in Table 1 attached to the ENFORCEMENT RULE OF THE ACT ON REGISTRATION AND EVALUATION OF CHEMICAL SUBSTANCES (화학물질의 등록 및 평가 등에 관한 법률 시행규칙). As the tonnage band increases, additional test reports are required. Standard information requirements are as follows:

0.1 – less than 1 ton a year
Test report relating to physical-chemical properties	1)    State of matter 2)    Water solubility 3)    Melting point/Freezing point 4)    Boiling point 5)    Vapor pressure
Test report relating to health hazards	1)    Acute oral toxicity (if it is a gas at room temperature or if its main route of exposure in use is inhalation, acute inhalation toxicity) 2)    Reverse mutation
Test report relating to environmental hazards	1)    Fish or daphnia acute toxicity 2)    Biodegradability

 

1 – less than 10 tons a year
Test report relating to physical-chemical properties	1)    State of matter 2)    Water solubility 3)    Melting point/Freezing point 4)    Boiling point 5)    Vapor pressure 6)    Octanol/Water partition coefficient 7)    Density 8)    Particle size analysis
Test report relating to health hazards	1)    Acute oral toxicity (if it is a gas at room temperature or if its main route of exposure in use is inhalation, acute inhalation toxicity) 2)    Reverse mutation 3)    Skin irritation/corrosion 4)    Skin sensitization
Test report relating to environmental hazards	1)    Fish acute toxicity 2)    Biodegradability 3)    Daphnia acute toxicity

 

10 – less than 100 tons a year
Test report relating to physical-chemical properties	1)    State of matter 2)    Water solubility 3)    Melting point/Freezing point 4)    Boiling point 5)    Vapor pressure 6)    Octanol/Water partition coefficient 7)    Density 8)    Particle size analysis 9)    Flammability 10) Explosiveness 11) Oxidation
Test report relating to health hazards	1)    Acute oral toxicity (if it is a gas at room temperature or if its main route of exposure in use is inhalation, acute inhalation toxicity) 2)    Reverse mutation 3)    Skin irritation/corrosion 4)    Skin sensitization 5)    Acute dermal toxicity or acute inhalation toxicity 6)    Eye irritation/corrosion 7)    Chromosomal aberration using mammalian cultured cells 8)    Somatic cell genotoxicity using lab animals 9)    Repeated dose toxicity (28 days) 10) Reproduction and developmental toxicity screening
Test report relating to environmental hazards	1)    Fish acute toxicity 2)    Biodegradability 3)    Daphnia acute toxicity 4)    Freshwater algae growth inhibition 5)    Hydrolysis according to pH

 

100 – less than 1,000 tons a year
Test report relating to physical-chemical properties	1)    State of matter 2)    Water solubility 3)    Melting point/Freezing point 4)    Boiling point 5)    Vapor pressure 6)    Octanol/Water partition coefficient 7)    Density 8)    Particle size analysis 9)    Flammability 10) Explosiveness 11) Oxidation 12) Viscosity 13) Dissociation constants
Test report relating to health hazards	1)    Acute oral toxicity (if it is a gas at room temperature or if its main route of exposure in use is inhalation, acute inhalation toxicity) 2)    Reverse mutation 3)    Skin irritation/corrosion 4)    Skin sensitization 5)    Acute dermal toxicity or acute inhalation toxicity 6)    Eye irritation/corrosion 7)    Chromosomal aberration using mammalian cultured cells 8)    Somatic cell genotoxicity using lab animals 9)    Repeated dose toxicity (28 days) 10) Reproduction and developmental toxicity screening 11) Additional genotoxicity (e.g. germ cell genotoxicity)
Test report relating to environmental hazards	1)    Fish acute toxicity 2)    Biodegradability 3)    Daphnia acute toxicity 4)    Freshwater alga growth inhibition 5)    Hydrolysis according to pH 6)    Intrinsic biodegradability 7)    Identification of degradation products 8)    Fish chronic toxicity 9)    Daphnia chronic toxicity 10) Terrestrial plant acute toxicity 11) Terrestrial invertebrate acute toxicity 12) Activated sludge respiration inhibition 13) Adsorption and desorption

 

1,000 tons or more a year
Test report relating to physical-chemical properties	1)    State of matter 2)    Water solubility 3)    Melting point/Freezing point 4)    Boiling point 5)    Vapor pressure 6)    Octanol/Water partition coefficient 7)    Density 8)    Particle size analysis 9)    Flammability 10) Explosiveness 11) Oxidation 12) Viscosity 13) Dissociation constants
Test report relating to health hazards	1)    Acute oral toxicity (if it is a gas at room temperature or if its main route of exposure in use is inhalation, acute inhalation toxicity) 2)    Reverse mutation 3)    Skin irritation/corrosion 4)    Skin sensitization 5)    Acute dermal toxicity or acute inhalation toxicity 6)    Eye irritation/corrosion 7)    Chromosomal aberration using mammalian cultured cells 8)    Somatic cell genotoxicity using lab animals 9)    Repeated dose toxicity (28 days) 10) Reproduction and developmental toxicity screening 11) Additional genotoxicity (e.g. germ cell genotoxicity) 12) Repeated dose toxicity (90 days) 13) Teratogenicity 14) Two-generation reproduction toxicity 15) Carcinogenicity
Test report relating to environmental hazards	1)    Fish acute toxicity 2)    Biodegradability 3)    Daphnia acute toxicity 4)    Freshwater alga growth inhibition 5)    Hydrolysis according to pH 6)    Intrinsic biodegradability 7)    Identification of degradation products 8)    Fish chronic toxicity 9)    Daphnia chronic toxicity 10) Terrestrial plant acute toxicity 11) Terrestrial invertebrate acute toxicity 12) Activated sludge respiration inhibition 13) Adsorption and desorption 14) Additional information on environmental behavior and dynamics 15) Terrestrial plant chronic toxicity 16) Terrestrial invertebrate chronic toxicity 17) Additional information on adsorption and desorption 18) Benthic organism chronic toxicity 19) Bioaccumulation

As it is required to register a phase-in substance when its manufacture/import volume is at least 1 ton, information requirements of tonnage band 0.1 – 1 is applicable only to non-phase-in substances.

Submitted test reports shall show that relevant test methods, as prescribed in the REGULATION ON TEST METHODS OF CHEMICAL SUBSTANCES (화학물질의 시험방법에 관한 규정) notified by the National Institute of Environmental Research (NIER), were adopted for the test. As the regulation refers to the OECD Test Guidelines for Chemicals, there are many cases where test reports prepared by testing agencies outside Korea are also valid in registering a chemical substance in Korea accompanied by a report summary written in Korean.

 

However, it shall be noted that the REGULATION ON TEST METHODS OF CHEMICAL SUBSTANCES is not exactly the same as the OECD Test Guidelines for Chemicals and NIER may request additional test reports when the test methods described in the submitted test report are not enough to comply with the regulation.

 

Below are the titles of test methods prescribed in the regulation.

A.       Tests of physical-chemical properties

1.       Partition coefficient test

2.       Melting point/Melting range test

3.       Boiling point test

4.       Water solubility test

5.       Vapor pressure test

6.       Solid and liquid density test

7.       Particle size distribution/Fiber length and diameter distribution test

8.       Hydrolysis test according to pH

9.       Water dissociation constant test

10.    Viscosity test of liquid

11.    Surface tension test of aqueous solution

12.    n-Octanol/Water partition coefficient test: High performance liquid chromatography method

13.    n-Octanol/Water partition coefficient test: Slow stirring method

14.    Flash point test

15.    Flammability Test

16.    Explosiveness test

17.    Autoignition and autoignition point Test

18.    Oxidation test

19.    Adsorption and desorption test using a batch equilibrium method

20.    Test for estimation of adsorption coefficient on soil and on sewage sludge by liquid chromatography

21.    Particle size and size distribution test of nanomaterials

22.    Dispersion stability test of nanomaterials in simulated environmental media

B.       Tests of ecological impact

1.       Freshwater algae growth inhibition test

2.       Daphnia acute toxicity test

3.       Fish acute toxicity test

4.       Avian reproduction toxicity test

5.       Earthworm acute toxicity test

6.       Terrestrial plant growth test

7.       Chronic toxicity test on plants

8.       Activated sludge respiration inhibition test

9.       Fish early-life stage toxicity test

10.    Daphnia fertility test

11.    Fish embryo and yolk-stage fry toxicity test

12.    Fish larvae growth test

13.    Earthworm reproduction toxicity test

14.    Chironomus sp. toxicity test (test to add test substances to sediment)

15.    Chironomus sp. toxicity test (test to add test substances to water)

16.    Fish embryo acute toxicity test

C.       Tests of degradability and concentration

1.       Microbial decomposition test (easy degradation): Dissolved organic carbon reduction test (I)

2.       Microbial decomposition test (easy degradation): Carbon dioxide emission measurement test

3.       Microbial decomposition test (easy degradation): Modified MITI Test I

4.       Microbial decomposition test (easy degradation): Dissolved oxygen consumption measurement test using a sealed test bottle

5.       Microbial decomposition test (easy degradation): Dissolved organic carbon reduction test (II)

6.       Microbial decomposition test (easy degradation): Oxygen consumption measurement test using a pressure gauge

7.       Microbial decomposition test (intrinsic degradation): Modified MITI Test II

8.       Soil Microorganism impact test

9.       Bioaccumulation test

10.    Aerobic and anaerobic transformation test in soil

11.    Aerobic and anaerobic transformation test in aquatic sediment

12.    Aerobic degradation of surface water: Simulated biodegradability test

13.    Microbial decomposition test (intrinsic degradation): Modified SCAS Test

14.    Microbial decomposition test (intrinsic degradation): Zahn-Wellens/EVPA Test

D.      Tests of health impact

1.       Acute dermal toxicity test

2.       Acute inhalation toxicity test

3.       Skin irritation and corrosion test

4.       Eye irritation and corrosion test

5.       Skin sensitization test

6.       28-day repeated oral administration toxicity test

7.       90-day repeated oral administration toxicity test

8.       21/28-day repeated transdermal administration toxicity test

9.       90-day repeated transdermal administration toxicity test

10.    28-day repeated inhalation toxicity test

11.    90-day repeated inhalation toxicity test

12.    Teratogenicity test

13.    Two-generation reproduction toxicity test

14.    Toxicokinetics test

15.    Acute oral toxicity test (fixed-dose method)

16.    Reproduction and developmental toxicity screening test

17.    Acute oral toxicity test (toxicity rating method)

18.    Rodent neurotoxicity test

19.    In vitro skin corrosion test (skin electrical resistance test)

20.    In vitro skin corrosion test (human skin model test)

21.    Carcinogenicity test

22.    Genotoxicity test (reverse mutation test using bacteria)

23.    Genotoxicity test (chromosomal aberration test using mammalian cultured cells)

24.    Genotoxicity test (micronucleus test using mammalian bone marrow cells)

25.    Genotoxicity test (chromosomal aberration test using mammalian spermatogonial cells)

26.    Acute oral toxicity test (dose up-and-down method)

27.    In vitro skin irritation test (human skin model test)

28.    Genotoxicity test (in vitro mammalian cell gene mutation test)

29.    Genotoxicity test (Rodent dominant lethal test)

30.    Genotoxicity test (chromosomal aberration test using mammalian bone marrow cells)

31.    Genotoxicity test (mouse heritable translocation test)

32.    Genotoxicity test (unscheduled DNA synthesis test using mammalian liver cells)

33.    Skin sensitization test (local lymph node assay, LLNA)

34.    Skin sensitization test (local lymph node assay, LLNA: DA)

35.    Skin sensitization test (local lymph node assay, LLNA: BrdU-ELISA)

36.    Chemical skin sensitization test (direct peptide reactivity assay, amino acid derivative reactivity assay)

37.    In vitro skin sensitization test (ARE-Nrf2 luciferase test)

38.    Acute inhalation toxicity test (toxicity rating method)

39.    Genotoxicity test (in vivo alkaline comet assay using mammals)

40.    90-day repeated oral administration toxicity test in non-rodents

41.    Combined reproduction/developmental toxicity screening test and repeated dose toxicity test

42.    Developmental neurotoxicity test

43.    Skin absorption test: In vivo test

44.    Skin absorption test: In vitro test

45.    In vitro 3T3 NRU phototoxicity test

46.    In vitro barrier test for skin corrosion assessment

47.    Bovine corneal opacity and permeability (BCOP) test

48.    Eye irritation test using isolated chicken eye (ICE)

49.    Rodent uterotrophic assay

50.    Male rat gonadotrophin response test

51.    Extended one-generation reproductive toxicity test

52.    Chronic toxicity test

53.    Combined chronic toxicity/carcinogenicity test

54.    Estrogen receptor transcriptional activation assay

55.    H295R Steroidogenesis Assay

56.    Eye corrosion and irritation fluorescein leakage test

57.    In vitro mammalian cell micronucleus test

58.    Transgenic rodent somatic and germ cell gene mutation assays

59.    Acute inhalation toxicity test (fixed concentration method)

60.    In vitro skin sensitization test

61.    Androgen receptor transcriptional activation assay

62.    Genotoxicity test (thymidine kinase gene mutation assay)

63.    In vitro eye irritation and damage test (statens seruminstitut rabbit cornea test)

64.    In vitro eye irritation and damage test (reconstructed human cornea-like epithelium test)

65.    Estrogen receptor binding assay

66.    Delayed neurotoxicity test of organophosphorus compounds: Acute oral toxicity test

67.    Delayed neurotoxicity test of organophosphorus compounds: 28-day repeated dose toxicity test

68.    Vitrigel-eye irritancy test

69.    Photoreactivity test using reactive oxygen species measurement (ROS test)

70.    In vitro eye irritation and damage test (macromolecule test method)