Defects in Toxicological Data that Lead to Pesticide Registration Application Rejection

Defects in Toxicological Data that Lead to Pesticide Registration Application Rejection in ChinaSubmission of a registration dossier is a prerequisite of any pesticide registration application in China. The dossier includes all the supporting data for the registration application. The dossier must often include data gathered from costly animal testing which is needed to generate reliable toxicological data, provide a scientific basis for safety evaluation, develop acceptable exposure level and classify, stratify and manage a pesticide based on its inherent risk to human health and the ecosystem. Due to the costs associated with generating toxicological data, failure to perform these tests correctly is a major source of concern for stakeholders.

In this article REACH24H’s Agrochemical department will offer a distillate of years of experience helping our clients register pesticides in China and share and troubleshoot the most frequently asked questions and problems encountered complying with China’s new pesticide regulatory system.

Formal Check

The pesticide registration application review process begins with a review of the formality of any application. Reviewers will take an initial check to assess the dossier in terms of data integrity, validity, and format. Dossiers with characteristics listed below are likely to be rejected:

  1. Tests conducted on TC/TK and formulated pesticides (including agricultural pesticides, household pesticides and rodenticides) are incomplete or fail to comply with the “Data requirements on pesticide registration (MoA announcement 2569)
  2. Issues with the report or a test report devoid of information for experimentation evaluation
  3. Lacking in written justification for experiment exemption or waive of health risk assessment report
  4. Data generated in unqualified laboratory. Toxicological test report should be issued by a MoARA-accredited lab or an overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China.
  5. Lacking of sample number, signatures of SD (Study Director) and TFM (Testing Facility Management) in test report and inconsistency between sponsor and applicant
  6. Inconsistency between test summaries/description and raw data
  7. Inconclusive LD50 and NOAEL data
  8. The course of experiment does not comply with GLP requirements;

Technical Flaws

After the formality check, reviewers will scrutinize the approach, content, course and outcome of the experiment. Major technical flaws are summarized as follows:

  1. The content of test report, experimental design, approach, observation, index and result processing do not conform to officially recognized testing guidelines
  2. Pesticides rated as hyper or highly toxic pesticide or highly toxic formulation using slightly or low toxic TC/TK will not be approved
  3. Formulations that are corrosive to eye and skin will not be approved. Eye and skin corrosive TC/TKs will be considered “case by case” and discussed at pesticide registration committee
  4. Skin-use formulation that is rated as moderate or highly irritating/corrosive to eye and skin irritant or rated as posing a risk of skin sensitization will not be approved. Other formulation rated as high or hyper skin sensitizers will also be rejected;
  5. Pesticides that are associated with delayed neurotoxicity will not be approved;
  6. Pesticide that obtains 2 positive results in 4 mutagenicity combination tests will not be approved;
  7. Microbial pesticide that are pathogenic to humans will not be approved
  8. If the RQ (Risk Quotient) that concluded from health risk assessment was greater than 1, the application will not be approved;
  9. If an indoor-use formulation is rated as moderately toxic it will not be approved;
  10. Lambda-cyhalothrin or Chlorpyrifos formulation intended for indoor spray will not be approved
  11. If a pesticide is severely toxic to humans and the applicant failed to submit information on safety precaution measures or medical treatment, the application will be rejected
  12. If the toxicity test is performed incorrectly the application will also be rejected. For example, in oral or inhalational toxicity test of a sand-formed granules (GR) using water-insoluble active ingredient, the GR should be administered in an organic solvent instead of water.



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