Analysis of the utilization of existing test data for phase-in substance registration under the Act on the Registration and Evaluation, etc. of Chemical Substances

Article information

Environ Health Toxicol. 2015;30 Suppl.s2015004
Publication date (electronic) : 2015 June 12
doi : https://doi.org/10.5620/eht.s2015004
1Environmental Safety Center, Korea Environmental Corporation, Incheon, Korea
2Department of Environmental Engineering, Inha Univercity, Incheon, Korea
Correspondence: Chang Gyun Kim 100 Inha-ro, Nam-gu, Incheon 402-751, Korea Tel: +82-32-860-7561 Fax: +82-32-865-1425 E-mail: cgk@inha.ac.kr
Received 2015 January 9; Accepted 2015 March 19.

Abstract

Objectives

Approximately 2000 phase-in substances are subject to registration according to the Act on the Registration and Evaluation, etc. of Chemical Substances (KREACH), and the expected testing cost is 2.06 trillion Korean won assuming all the test data required for registration are acquired. The extent to which these enormous test costs can be reduced depends on the availability of existing data that can be used to meet the requirements of the K-REACH we examined the current availability of test data that can be used for chemical substance registration.

Methods

We analyzed the possibility of utilizing the existing test data obtained from 16 reference databases for 369 of 518 kinds of phase-in substances subject to registration that were reported in last October 2014.

Results

The physical and chemical properties were available for 57.1% of substances, whereas data regarding human hazards and environmental hazards were available at considerably lower rates, 8.5% and 11.8%, respectively.

Conclusions

Physical and chemical properties were available for a fairly high proportion, whereas human hazards and environmental hazards were reported for considerably fewer substances.

Introduction

The Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH) has been effective in the Republic of Korea (hereafter Korea) since January 1, 2015. According to the law, those who produce or import more than one ton of phasein substances yearly or any quantity of a new chemical substance must register at the National Institute of Environmental Research. Approximately 2000 types of phase-in substances are expected to be subject to registration, and the test data required for registration vary depending on the amount produced or imported (i.e., 15 test items for 1 to 10 tonnes, 26 items for 10 to 100 tonnes, 37 items for 100 to 1000 tonnes, and 47 items for greater than 1000 tonnes). If all test data were requested and acquired by the appropriate research institute, the predicted cost is 35 million Korean won (KRW) per substance for 1 to 10 tonnes, 96 million KRW for 10 to 100 tonnes, 410 million KRW for 100 to 1000 tonnes, and 1.03 billion KRW for greater than 1000 tonnes [1]. According to the K-REACH, multiple companies that attempt to register the same substance are required to produce a single set of test data and register jointly to minimize the registration cost for phase-in substances. In addition, when test data have previously been generated, permission from the owner of the corresponding test data should be obtained, either for a fee or at no cost. Considering that most of the phase-in substances subject to registration are produced or imported at volumes of great than 1000 tonnes, the cost of generating test data for the approximately 2000 kinds of phase-in substances subject to registration is expected to be 2.06 trillion KRW. The extent to which this enormous test cost can be reduced depends on the quantity of the existing test data and the cost of obtaining this data. In this study, we examined the current availability of test data that can be used for chemical substance registration in accordance with the K-REACH for 369 of 518 kinds of phasein substances subject to registration that were reported on October 31, 2014.

Materials and Methods

Subjects

For each of the 369 kinds of phase-in substances subject to registration out of 518 total kinds that were reported in October 2014, 47 test items (data regarding 13 physical and chemical properties, 15 human hazards, and 19 environmental hazards) that are required for chemical substance registration according to the K-REACH were examined (Table S1) [2].

Methods

Using 16 reference databases (DBs) that contain the test data for chemical substances, the availability of the existing test data for 47 test items and 369 kinds of phase-in substances subject to registration was assessed (Table S2).

Feasibility of existing test data for registration The reliability of the test data derived from the 16 reference DBs was classified according to such as the good laboratory practices (GLP) established by the Organization for Economic Cooperation and Development (OECD) (Table S3). If a test was objectively verified as meeting GLP regulations of the OECD, an international test guideline, or was published in Science Citation Index, it was assigned a reliability of 1. If a test did not meet the requirements necessary to be assigned a reliability of 1, but the methods were specified and scientifically validated, it was assigned a reliability of 2. If a test was implemented without accredited methods or could not be scientifically validated, it was assigned a reliability of 3. For the test items in the K-REACH that only accept test data generated according to GLP regulations (1 item in physical and chemical properties, 15 items in human hazards, and 14 items in environmental hazards), only test data with reliability scores of 1 are likely to be approved. However, for the test items accept test date generated without following GLP regulations (12 items in physical and chemical properties and 5 items in environmental hazards), test data with reliability scores of 1 and 2 are likely to be approved.

Results

Feasibility of Existing Test Data on Physical and Chemical Properties

The existing test data on physical and chemical properties show that 2.1% of substances had test data with a reliability of 1, 59.3% had data with a reliability of 2, 0.9% had data with a reliability of 3, and 37.7% of substances did not have test data. Assuming that only those with a reliability of 1 for the octanol-water partition coefficient are approved for phase-in substance registration based on the K-REACH, and that the existing test data with reliability scores of 1 and 2 for other test items are approved, the probability that the existing test data on physical and chemical properties can be utilized is 57.1% (Table 1).

Percentage of substances with existing test data on physical and chemical properties

Feasibility of Existing Test Data on Human Hazards

Based on the existing test data on human hazards, it can be concluded that 8.5% of substances had test data with a reliability of 1, 37.3% had data with a reliability of 2, 0.3% had data with a reliability of 3, and 53.5% did not have test data. Assuming that only the existing testing data with reliability scores of 1 are approved for phase-in substance registration according to the guidelines of the K-REACH, the probability that the existing test data on human hazards can be utilized is 8.5% (Table 2).

Percentage of substances with existing test data on human hazards

Feasibility of Existing test Data on Environmental Hazards

The existing test data on environmental hazards show that 6.5% of substances had test data with a reliability of 1, 19.6% had data with a reliability of 2, 0.1% had data with a reliability of 3, and 73.8% did not have test data. Assuming that the existing test data with reliability scores of 1 and 2 for pH-dependent hydrolysis, verification of degradation product , adsorption and desorption, additional information on environmental behavior and movement, and additional information on adsorption and desorption are approved for phase-in substance registration according to the guidelines of K-REACH, and that only those with reliability scores of 1 for other test data are approved, the probability that existing test data on environmental hazards can be utilized is 11.8% (Table 3).

Possibility of utilizing existing test data on environmental hazards

Discussion

We analyzed the possibility of utilizing the existing test data contained in 16 reference DBs for 369 of 518 kinds of phase-in substances subject to registration that were reported in October 2014. The physical and chemical properties were available for 57.1% of substances, whereas data regarding human hazards and environmental hazards were available at considerably lower rates, 8.5% and 11.8%, respectively. Our analysis of the use of the existing test data was limited to 16 reference DBs; therefore, additional data may be obtained by using the other DBs. Chemical companies that need to register phase-in substances according to the K-REACH should use the existing test data to minimize registration costs.

Acknowledgements

This study was supported by the Korea Ministry of Environment (MOE) as “MOE’s R&D Program on environmental technology development” (no. 412-111-005).

Notes

The authors have no conflicts of interest with material presented in this paper.

Supplementary Material

Table S1.

Test items required for chemical substance registration

Table S2.

Reference databases (DBs)

Table S3.

Judgment criteria for reliability

References

1. Lee J. Cost-benefit analysis (focused on direct expense) according to the enactment of the ‘Act on the Registration & Evaluation, etc. of Chemical Substances’ [dissertation] Seoul: Korea University; 2012. (Korean).
2. Ministry of Government Legislation. Act on the Registration and Evaluation, etc. of Chemical Substances [cited 2015 Mar 31]. Available from: http://www.law.go.kr/lsInfoP.do?lsiSeq=140402#0000 (Korean).

Article information Continued

Table 1.

Percentage of substances with existing test data on physical and chemical properties

Classification Substances with existing test data (%)
Total Reliability 1 Reliability 2 Reliability 3 No data
Physical state 369 (100) 0 (0.0) 334 (90.5) 0 (0.0) 35 (9.5)
Water solubility 369 (100) 16 (4.3) 312 (84.6) 1 (0.3) 40 (10.8)
Melting/freezing point 369 (100) 13 (3.5) 306 (82.9) 2 (0.6) 48 (13.0)
Boiling point 369 (100) 5 (1.3) 266 (72.1) 2 (0.6) 96 (26.0)
Vapor pressure 369 (100) 13 (3.5) 264 (71.5) 1 (0.3) 91 (24.7)
Octanol-water partition coefficient 369 (100) 27 (7.3) 209 (56.6) 0 (0.0) 133 (36.1)
Density 369 (100) 5 (1.4) 171 (46.3) 6 (1.6) 187 (50.7)
Particle size 369 (100) 0 (0.0) 0 (0.0) 0 (0.0) 369 (100.0)
Flammability 369 (100) 14 (3.8) 209 (56.6) 13 (3.5) 133 (36.0)
Explosiveness 369 (100) 5 (1.3) 285 (77.2) 8 (2.2) 71 (19.3)
Oxidation 369 (100) 3 (0.8) 264 (71.5) 7 (1.9) 95 (25.8)
Viscosity 369 (100) 0 (0.0) 142 (38.5) 1 (0.3) 226 (61.2)
Dissociation constant 369 (100) 1 (0.3) 83 (22.5) 0 (0.0) 285 (77.2)
Total 4797 (100) 102 (2.1) 2845 (59.3) 41 (0.9) 1809 (37.7)

Table 2.

Percentage of substances with existing test data on human hazards

Classification Substances with existing test data (%)
Classification Total Reliability 1 Reliability 2 Reliability 3 No data
Acute oral toxicity 369 (100) 29 (7.9) 209 (56.6) 2 (0.5) 129 (35.0)
Revers mutation 369 (100) 57 (15.4) 207 (56.1) 1 (0.3) 104 (28.2)
Skin irritation/corrosiveness 369 (100) 40 (10.8) 169 (45.8) 1 (0.3) 159 (43.1)
Skin hypersensitivity 369 (100) 30 (8.1) 100 (27.1) 3 (0.8) 236 (64.0)
Acute dermal toxicity 369 (100) 16 (4.3) 156 (42.3) 3 (0.8) 194 (52.6)
Eye irritation/corrosiveness 369 (100) 35 (9.5) 194 (52.6) 2 (0.5) 138 (37.4)
Chromosome aberration using mammalian culture cells 369 (100) 29 (7.7) 150 (40.6) 1 (0.3) 189 (51.2)
Genetic toxicity using test animals 369 (100) 31 (8.4) 130 (35.2) 1 (0.3) 207 (56.1)
Subacute toxicity (28 d) 369 (100) 19 (5.1) 97 (26.3) 0 (0.0) 253 (68.6)
Reproductive and developmental toxicity 369 (100) 21 (5.7) 139 (37.7) 1 (0.3) 208 (56.3)
Additional genetic toxicity (genetic toxicity of germ cells, etc.) 369 (100) 7 (1.9) 53 (14.4) 0 (0.0) 309 (83.7)
Subchronic toxicity (90 d) 369 (100) 57 (15.4) 207 (56.1) 1 (0.3) 104 (28.2)
Teratogenicity 369 (100) 22 (6.0) 116 (31.4) 0 (0.0) 231 (62.6)
2nd generation reproductive toxicity 369 (100) 12 (3.2) 52 (14.1) 0 (0.0) 305 (82.7)
Carcinogenicity 369 (100) 64 (17.3) 108 (29.3) 0 (0.0) 197 (53.4)
Total 5535 (100) 469 (8.5) 2087 (37.7) 16 (0.3) 2963 (53.5)

Table 3.

Possibility of utilizing existing test data on environmental hazards

Classification Substances with existing test data (%)
Total Reliability 1 Reliability 2 Reliability 3 No data
Fish acute toxicity 369 (100) 66 (17.9) 171 (46.3) 0 (0.0) 132 (35.8)
Biodegradation (ready) 369 (100) 100 (27.1) 92 (24.9) 1 (0.3) 176 (47.7)
Water flea acute toxicity 369 (100) 81 (21.9) 160 (43.4) 0 (0.0) 128 (34.7)
Fresh water algae growth inhibition 369 (100) 52 (14.1) 105 (28.4) 0 (0.0) 212 (57.5)
pH-dependent hydrolysis 369 (100) 4 (1.1) 150 (40.6) 0 (0.0) 215 (58.3)
Biodegradation (inherent) 369 (100) 39 (10.6) 16 (4.3) 3 (0.8) 311 (84.3)
Verification of degradation product 369 (100) 0 (0.0) 14 (3.8) 1 (0.3) 354 (95.9)
Fish chronic toxicity 369 (100) 6 (1.6) 66 (17.9) 0 (0.0) 297 (80.5)
Water flea chronic toxicity 369 (100) 25 (6.8) 72 (19.5) 0 (0.0) 272 (73.7)
Land plant acute toxicity 369 (100) 7 (1.9) 61 (16.5) 0 (0.0) 301 (81.6)
Land invertebrate acute toxicity 369 (100) 12 (3.3) 38 (10.3) 0 (0.0) 319 (86.4)
Activated sludge respiration inhibition 369 (100) 34 (9.2) 18 (4.9) 0 (0.0) 317 (85.9)
Adsorption and desorption 369 (100) 2 (0.5) 177 (48.0) 0 (0.0) 190 (51.5)
Additional information on environmental behavior and movement 369 (100) 0 (0.0) 0 (0.0) 0 (0.0) 369 (100.0)
Land plant chronic toxicity 369 (100) 2 (0.5) 29 (7.9) 0 (0.0) 338 (91.6)
Land invertebrate chronic toxicity 369 (100) 4 (1.1) 22 (6.0) 0 (0.0) 343 (92.9)
Additional information on adsorption and desorption 369 (100) 0 (0.0) 1 (0.3) 0 (0.0) 368 (99.7)
Benthos chronic toxicity 369 (100) 0 (0.0) 7 (1.9) 0 (0.0) 362 (98.1)
Bioaccumulation 369 (100) 24 (6.5) 178 (48.2) 0 (0.0) 167 (45.3)
Total 7011 (100) 458 (6.5) 1377 (19.6) 5 (0.1) 5171 (73.8)