It’s an industry-known fact that the European Chemical Agency (ECHA) has continuously been on researching about the alternative methods that have been used to generate information on the intrinsic properties of chemical substances and for risk assessment. Following the previous three reports, the Agency has now published its fourth report based on registration datasets obtained in 2016 and 2019 with a comprehensive understanding of the scope of alternative methods and testing strategies for all registered chemicals in the EU.

The main objective of these reports is said to be promoting non-animal testing methods and other alternatives. The latest report shows a few changes in the use of alternatives to animal testing. The most common adaptation pattern is listed out as:

  • Read across (25%)
  • Data waiving
  • Weight of Evidence
  • predicting properties from structurally similar substances using computer models (QSAR)

ECHA mentioned in its findings that weight of evidence, QSAR and data waiving methods had specifically increased for acute toxicity testing on substances that are registered between 10-100 tonnes per year. There were 3% fewer experimental studies used for this endpoint. The low volume substances that produced 1-10 tonnes per year, also saw fewer experimental studies conducted in favor of adaptations.

All said and done, considering the new report, we can conclude that the alternatives to animal testing are being widely used. This probably results in good result for the amendment of the REACH annexes in 2016, which had clearly mentioned companies are required to use non-animal testing (in vitroin chemico) for certain endpoints. For continuous updates on the Regulatory best practices, consult a proven Regulatory partner.

 

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