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A Comparison of Dose-Response Assessments for CMR Materials in the Workplace

작업장에서 취급하는 CMR물질의 용량반응평가 방법 비교

  • Received : 2018.02.07
  • Accepted : 2018.03.27
  • Published : 2018.03.30

Abstract

Objectives: Currently, there is only limited knowledge regarding the hazard of low-level exposure to CMR materials in workplaces. To overcome this limitation, a reference concentration for workers($RfC_w$) from among the risk assessment tools proposed by the US EPA is widely used to set a provisional workplace exposure level(PWEL) for CMR materials for which there are no established Korea Occupational Exposure Limits(KOELs) or subjective chemicals for work environment measurements as regulated by Korea Ministry of Employment and Labor(KMOEL). A simple European calculator of derived no effect level(SECO-DNEL) as proposed by REACH can also be used in place of $RfC_w$ to set the PWEL for chemicals. This study was performed to test the acceptability of using SECO-DNEL as an alternative to $RfC_w$ when setting a PWEL for low-level exposures. Methods: The $RfC_w$ and DNEL for the five CMR materials of dinitrogen oxide, catechol, 2-phenoxy ethanol, carbitol, and carbon black were calculated using the dose-response assessments of the US EPA for $RfC_w$ and REACH guidance for SECO-DNEL, respectively. They were compared using paired t-tests to determine the statistical differences between them. Results: For the five chemicals, the $RfC_w$ were 2.53 ppm, 0.10 ppm, 1.73 ppm, 1.66 ppm, and $0.05mg/m^3$, respectively, while the SECO-DNEL were 2.01 ppm, 0.11 ppm, 1.83 ppm, 1.77 ppm, $0.14mg/m^3$, respectively. There was no statistically significant difference between $RfC_w$ and SECO-DNEL. Conclusions: This study suggests that the SECO-DNEL could be applied in place of $RfC_w$ to set a PWEL for low-level exposure to chemicals, especially CMR materials. To further ensure the reliability of SECO-DNEL as an alternative tool, more chemicals should be applied for calculation and comparison with $RfC_w$.

Keywords

References

  1. Boojaard PJ, Banton MI, Dalbey W, Hedelin AS, Riley AJ et al. A consistent and transparent approach for calculation of Derived No-Effect Levels (DNELs) for petroleum substances. Regulatory Toxicology and Pharmacology 2012;62:85-98 https://doi.org/10.1016/j.yrtph.2011.11.016
  2. European Commission (EC). Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation (EC) No. 1907/2006 of the European Parliament and of the Council. Off. J. Eur. Commun 2006;L396/17:1.849
  3. European Commission (EC). Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EC, 93/67/EEC, 93/105/ EC and 2001/21/EC. Vol. 1907/2006, 2006
  4. European Chemicals Agency(ECHA). Guidance on Information Requirements and Chemical Safety Assessment, Part A: Introduction to the Guidance Document. 2008
  5. European Chemicals Agency(ECHA). Guidance on Information Requirements and Chemical Safety Assessment Part B: Hazard Assessment. 2008
  6. European Chemicals Agency(ECHA). List of pre-registered substances. [cited 2009 Jul 1] Available from:URL: http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx/
  7. European Chemicals Agency(ECHA). Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8: Characterisation of dose[concentration]-response for human health. 2011
  8. European Chemicals Agency(ECHA). Guidance on Information Requirements and Chemical Safety Assessment, Part B: Hazard Assessment. 2012
  9. European Chemicals Agency(ECHA). Chapter R.8: Characterisation of dose [concentration]-response for human health. [cited 2014 Nov 19] Available from:URL: http://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf
  10. Gift JS, McGaughy R, Singh DV, Sonawane B. Health assessment of phosgene: Approaches for derivation of reference concentration. Regulatory Toxicology and Pharmacology 51 2008;98-107 https://doi.org/10.1016/j.yrtph.2008.03.004
  11. Kim YM, Kim HW. The assessment of health risk and subjective symptoms of printing workers exposed to mixed organic solvents. J Korean Soc Occp Envirn Hyg 2009;19(3):270-279
  12. Kreider ML, Williams ES. Interpreting REACH guidance in the determination of the derived no effect level (DNEL). Regulatory Toxicology and Pharmacology 2010;58:323-329 https://doi.org/10.1016/j.yrtph.2010.07.005
  13. Kim HJ, Shin DC, Lim YW, Yang JY, Lee YJ. Dose-Response Assessment of Isoprene for Occupational Health Protection Target Level. J Health Info Stat 2011;36(1):63-75
  14. Kim CN, Roh JH, Won JU, KIM TH, Yang JY et al. Hazard assessment of hazardous chemical substances ( II ). Occupational Safety and Health Research Institute Korea Occupational Safety & Health Agency, 2012
  15. Korea Occupational Safety & Health Agency. Guidelines for evaluating the hazard of chemical substances. 2016
  16. Lim CH, Yang JS, Park SY. A Harmonized Method for Dose-response Risk Assessment Based on the Hazard & Risk Evaluation of Chemicals (HREC) According to the Industrial Safety and Health Act (ISHA). J Korean Soc Occup Environ Hyg 2012:22(3):175-183
  17. Lim YW, Roh YM, Shin YC, Yang JY, Lee YJ et al. Detailed review of management standard for high risk chemicals. Korea Occupational Safety & Health Agency(KOSHA) 2012
  18. Ministry of Employment and Labor. Enforcement rule of the Occupational Safety and Health act. (MoL Public Notice No. 2016-197) 2016
  19. Ministry of Employment and Labor. Exposure limits for Chemical Substances and Physical Agents. (MoL Public Notice No. 2016-41) 2016
  20. Ministry of Employment and Labor, Regulation on hazard assessment of chemical substances. (MoL Public Notice No. 2017-125) 2017
  21. Moon HI, Choi HI, Sin SM, Byeon SH. Human Health Risk Assessment of n-Butyl Glycidyl Ether from Occupational Workplaces. J Korean Soc Occup Environ Hyg 2013:23(1):20-26
  22. Boogaard PJ, Banton Mi, Dalbey W, Hedelin AS, Riley AJ et al. A consistent and transparent approach for calculation of Derived No-Effect Levels (DNELs) for petroleum substances. Regulatory Toxicology and Pharmacology 2012;62:85-98 https://doi.org/10.1016/j.yrtph.2011.11.016
  23. Schenk L, Deng U, Johanson G. Derived No-effect Levels (DNELs) under the European Chemicals Regulation REACH- An Analysis of Long-term Inhalation Worker-DNELs Presented by Industry. Ann. Occup. Hyg 2015;59(4):416-438 https://doi.org/10.1093/annhyg/meu103
  24. US Environmental Protection Agency(U.S. EPA). Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. EPA/600/8-90/ 066F [cited 2014] Available from:URL:National Technical Information Service, Springfield, VA
  25. Williams, ES, Panko, JM, Paustenbach, DJ. The European Union's REACH regulation: a review of its history and requirements. Crit. Rev. Toxicol 2009;39;553-575 https://doi.org/10.1080/10408440903036056
  26. Yoon YH, Lee SW, Jung HH, Kim KS. Evaluation of the Application of worker-DNELs under REACH Guidance as Provisional Occupational Exposure Limits in the Workplace. J Korean Soc Occup Environ Hyg 2013:23(1):27-34