Recent Concerns Regarding Lilial® in Popular Hair Care Products

Posted on Behalf of  Alex Schulte, Kathleen Chen

Recent media attention highlighting the use of Lilial® in a popular shampoo brand has sparked consumer concern given the recent ban of the ingredient in Europe and the continued use of the compound in hundreds of well-known products in the United States (Refinery29, 2022; EWG’s Skin Deep, 2022). Lilial®, also known as butylphenyl methylpropional (CAS # 80-54-6), is widely used in personal care and household products (PubChem, 2022). As a result of the scented nature of the compound, Lilial® has been added to a vast array of consumer products, including shampoos, conditioners, lotions, soaps, and detergents, as a fragrance ingredient (PubChem, 2022, EWG’s Skin Deep, 2022). Due to reported associations between Lilial® and damage to fertility in oral non-clinical studies, the European Union (EU) and United Kingdom (UK) began regulating the use of the ingredient in cosmetic products in 2009 and officially banned the use of the compound in cosmetic products in March of 2022 (Refinery29, 2022; Regulation (EC) No 1223/2009, 2009; PubChem, 2022).

Lilial® is classified as a 1B reproductive toxicant according to the EU Regulation on the classification, labelling, and packaging of substances and mixtures, a Category 2 reproductive toxicant according to Global Harmonizing System (GHS) classification, and a Substance of Very High Concern (SVHC) under European Chemicals Agency’s Registration, Evaluation, Authorization, and Restriction of Chemicals (ECHA’s REACH) Regulation (PubChem, 2022; SDS, 2015). It is important to note that these classifications appear to be based on oral toxicity data obtained from repeated dose non-clinical studies, and do not necessarily reflect the true exposure of Lilial® to the consumer of shampoos (SCCS, 2019; ECHA, 2022; PubChem, 2022). In particular, the Scientific Committee on Consumer Safety (SCCS) noted that the adverse effects of Lilial® on reproductive endpoints occurred only at non-clinical dermal exposure doses well in excess of oral doses associated with toxicity (SCCS, 2019). Thus, it is necessary to appropriately assess the potential health risks to consumers of shampoos containing Lilial® by conducting a human health risk assessment.

There are many factors that must be considered when evaluating the overall risks associated with the use of consumer products. Specifically, the concentration of the chemical in the product, the route of exposure (e.g. dermal versus oral), and the exposure duration (e.g. acute versus chronic) each play an important role in determining the potential risk of adverse health effects from exposure to a compound. Until a robust human health risk assessment that considers each of these factors is conducted, the potential health risks, including reproductive toxicity, associated with using shampoos containing Lilial® will not be entirely understood.

Cardno ChemRisk’s scientists have extensive experience in performing risk assessments and providing recommendations pertaining to human and environmental health. In particular, Cardno ChemRisk’s scientists have conducted numerous health risk assessments related to personal care products, including hair care products (Towle et al., 2018, Fung et al., 2018). Please contact Dr. Ernest Fung for more information regarding Cardno ChemRisk’s capabilities.