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South Korea to permit alternatives to test reports for registration

Qualifying scientific literature, toxicity databases and assessment reports can be acceptable


The National Institute of Environmental Research (Nier) has produced guidelines for acceptable alternative data that can be submitted in place of test reports produced by a qualified testing laboratory (GLP) or robust study summaries (RSSs).

Nier is to allow data from qualifying scientific literature, toxicity databases and assessment reports from recognised industry organisations. This includes:

  • academic journal papers, such as a widely recognised research paper that contains chemical test results;
  • science handbooks, for example, the Merck Index (an encyclopaedia of chemicals, drugs and biologicals); and
  • toxicity databases, including the US National Library of Medicine’s Hazardous Substances Data Bank, Iuclid or the US EPA’s Integrated Risk Information System (IRIS).

In addition, data can be used from assessment reports, produced by overseas organisations, such as:

  •  OECD’s screening information data set (SIDS);
  •  International Agency for Research on Cancer (Iarc) monographs;
  •  EU risk assessment reports (RARs);
  •  US EPA Registration Eligibility Decisions for pesticides; and
  •  WHO chemical substances assessments.

For literature to qualify, the following must apply:

  • the test result (including test methods, result value and conclusion) of the hazardousness of the tested item, the endpoint, is presented in detail;
  • it is judged by Nier to have followed internationally approved test methods;
  • it was used for essential reference for hazard or risk assessment and for classification, according to the UN Globally Harmonized System (GHS); and
  • if a widely approved science handbook, such as the Merck Index, the British Crop Production Council’s pesticides manual or the US National Library of Medicine’s Hazardous Substances Data Bank, contains the test result of a physical and chemical property.