EU PPP registration
In all cases of new/increased levels of impurities, need: toxicology (Q)SAR analysis, if a reliable prediction is possible and can be supported scientifically. If there is an SAR alert for the impurity, it should be considered if this alert is also present in the active substance (and hence whether the potential concern is addressed by studies on the active substance). It might be considered appropriate to having a closer look at the alert and the structure triggering the alert or to investigate further to determine the validity of the alert in this particular case, e.g., by conducting a study.
Mexico pesticide registration
When new impurities whose concentration is ≥ 1% (1g / kg), their non-relevance should be justified by:
a) Structure-activity analysis (QSAR), whereby a value of LD50 is obtained, and this is applied in the formula in Appendix J of the FAO Manual. It should be mentioned that the LD50 value of the active ingredient to be used should be that obtained experimentally.
b) Establish that the toxicity of the impurity is equal to or less than that of the active ingredient when comparing LD50, LC50 or other toxicological parameter using in vivo studies
c) Mutagenicity study
Brazil pesticide registration
Equivalence of technical:
a) In all cases of new impurities or enhanced levels of impurities are required studies of structure-activity relationship, covering all endpoints required for the evaluation of a technical product using different expert systems, and support data to explain why these impurities are non-relevant;
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