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Updated: May 22, 2025

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Making safety decisions for a sunscreen active ingredient using next-generation risk assessment: Benzophenone-4 case

Maria T Baltazar1, Sophie Cable1, Richard Cubberley1

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|May 21, 2025
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Summary

Next-generation risk assessment (NGRA) using non-animal methods shows benzophenone-4 (BP-4) is safe. This approach provides reliable safety data for UV filters without animal testing.

Keywords:
alternative approachesanimal-free risk-assessmentcosmetics safetyexposure scenarionew approach methodologies (NAMs)next-generation risk assessment (NGRA)

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Area of Science:

  • Toxicology
  • Risk Assessment
  • Dermatology

Background:

  • Benzophenone-4 (BP-4) is a UV filter used in body lotions.
  • Traditional safety assessments often rely on animal data.
  • Evaluating BP-4 safety using non-animal methods is crucial for regulatory compliance and ethical considerations.

Purpose of the Study:

  • To conduct a next-generation risk assessment (NGRA) for BP-4.
  • To compare a non-animal approach with traditional safety assessment methods.
  • To evaluate the safety of BP-4 in a body lotion at a 5% concentration.

Main Methods:

  • Physiologically-based kinetic (PBK) modeling to predict BP-4 absorption, metabolism, and excretion.
  • In silico and in vitro new approach methodologies (NAMs) to characterize bioactivity.
  • Calculation of bioactivity:exposure ratios (BERs) using in vitro points of departure (PoDNAM) and predicted plasma Cmax.

Main Results:

  • PBK modeling predicted low systemic exposure to BP-4 (plasma Cmax of 1.27 µM).
  • Most calculated BERs were above 11, indicating a sufficient safety margin.
  • Lowest BERs (3.3 and 4.3) were linked to adaptive gene transcription changes, not adverse effects.

Conclusions:

  • NGRA provides a robust, non-animal approach for evaluating UV filter safety.
  • BP-4 demonstrates a favorable safety profile at 5% in body lotion.
  • This study supports the regulatory acceptance of NAMs in chemical safety assessments.