Case study for the integrated approaches for testing and assessment of propylparaben (PrP) from multiple sources using ASPA (NV/CBC/MONO(2026)29, 69 pages, 6. October 2026; Eleventh Review Cycle, 2025) OECD Environment, Health and Safety Publications SERIES ON TESTING AND ASSESSMENT NO. 448, OECD, Paris

Zenodo (CERN European Organization for Nuclear Research)

Abstract

OECD 2026 (core authors: Ouedraogo G, Affourtit F, Delmaar C, Luijten M, Islam B, Gardner I, Kunnen S, de Boer T, Ottenbros I, Braakhuis H, Telleria J, Furlong L, Wedebye E, Bunmahotama W, Nikolov N, Nissen A, Kamp H, White A, Leist M, Sahlin U, van de Water B (2026) Case study for the integrated approaches for testing and assessment of propylparaben (PrP) from multiple sources using ASPA (NV/CBC/MONO(2026)29, 69 pages, 6. October 2026; Eleventh Review Cycle, 2025)OECD Environment, Health and Safety Publications SERIES ON TESTING AND ASSESSMENT NO. 448, OECD, Paris Propylparaben is an ester of para hydroxybenzoic acid that is used in consumer goods like aqueous toys and personal care products as well as in pharmaceuticals as preservatives.In Europe, propylparaben can be used as a preservative in cosmetics up to 0.18% as ester or 0.14% as acid. It can be found in body paints as well as in toys. Its use as food additive is not authorized, although it can be used as a food contact material. In the current work, the use in drugs was not addressed.An IATA on the use of propylparaben in cosmetics exists and addressed exposure from cosmetics products based on read-across enhanced by NAMs.Here, the exposure is expanded to encompass use of propylparaben in personal care products and aqueous toys (putty, slime and finger paint) and the assessment is made using the ASPIS Safety Assessment Algorithm (ASPA) as a framework for next-generation risk assessment (NGRA) with a focus on systemic effects.The problem formulated is the following: is the combined use of propylparaben at maximum concentration from personal care products, consumer goods (putty, slime and finger paint) and toys safe for consumers? The working hypothesis is that propylparaben lacks systemic toxicity data and that no suitable analogue exists. The assumption is that all other effects (local, sensitization and genotoxicity…) were evaluated and there is no concern.There are regulatory opinions on the safe use of propyl paraben (e.g., SCCS https://health.ec.europa.eu/system/files/2022-08/sccs_o_243.pdf%20 and CIR https://www.cir-safety.org/sites/default/files/Parabens_0.pdf). In the SCCS opinion (243), it is stated that “Propylparaben can maximally be used in any cosmetic product up to 0.14% (alone, as acid) or up to a maximum of 0.14% (as acid), as the sum of the individual concentrations of butyl paraben and propylparaben, when used together as a binary mixture in the same product. This would be equivalent to a maximum concentration of propylparaben of 0.183% in cosmetic products.”Data from the literature and newly generated from RISK-HUNT3R were used through the exposure, the ADME/tk and toxicodynamics parts of ASPA were integrated to come to a safety decision. The origional repository may be found here (October 2026): https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/publications-on-testing-and-assessment-of-chemicals.html

Authors 3

1. Marcel Leist

   University of Konstanz

   Affiliation as printed

   University of Konstanz

2. Gladys Ouedraogo

   L'Oréal (France)

   Affiliation as printed

   L'Oréal (France)

3. Bob van de Water Aachen

   Leiden University

   Affiliation as printed

   Leiden University