Is Octisalate Safe to Use During Pregnancy?

Octisalate, also known by its chemical name Ethylhexyl Salicylate, is a common chemical UV filter found in many sunscreens, cosmetics, and personal care products. The safety of ingredients applied to the skin becomes a significant concern during pregnancy, given the potential for absorption and fetal exposure. This article provides an overview of Octisalate’s function, its systemic absorption profile, and the scientific findings related to its use during pregnancy.

Understanding Octisalate and Its Function

Octisalate is an organic compound used primarily as a chemical UV filter in sunscreens. Chemically, it is an ester derived from salicylic acid, which helps ensure its solubility. Its main purpose is the absorption of ultraviolet B (UVB) radiation, which is responsible for sunburn.

It is rarely used as the sole active ingredient due to its limited protection capabilities, as it offers minimal short-wave UVA coverage. Consequently, Octisalate is typically combined with other UV filters, such as avobenzone or homosalate, to achieve broad-spectrum protection. It also acts as a stabilizer for less photostable filters like avobenzone. This ingredient is globally approved for use in sunscreens at a maximum concentration of 5%.

Skin Absorption and Systemic Exposure

Unlike mineral UV filters, which sit on the skin’s surface, Octisalate is an organic filter designed to penetrate the skin. This allows it to be readily absorbed into the body and enter the systemic circulation. Recent clinical trials conducted by the U.S. Food and Drug Administration (FDA) have confirmed this systemic absorption for Octisalate and other chemical filters.

The FDA established a threshold of concern for systemic exposure at 0.5 nanograms per milliliter (ng/mL) of plasma, above which further safety testing is requested. Studies showed that Octisalate concentrations in the blood reached levels significantly higher than this threshold after maximal-use conditions. For instance, geometric mean maximum plasma concentrations for Octisalate ranged from 4.6 ng/mL to 5.8 ng/mL, depending on the product formulation. Continuous, regular use can lead to bioaccumulation, meaning the concentration in the bloodstream continues to rise with repeated application.

Scientific Findings on Fetal Development

The concern regarding Octisalate’s systemic presence is heightened during pregnancy because the developing fetus is sensitive to chemical exposure. Octisalate belongs to a group of compounds that have been classified as potential endocrine-disrupting chemicals (EDCs). EDCs are substances that can interfere with the body’s endocrine system, which regulates hormones necessary for proper fetal development.

While direct, conclusive human data specifically linking Octisalate exposure to adverse birth outcomes is limited, the precautionary principle is often applied due to its potential as an EDC. Studies on structurally similar salicylate compounds and other chemical UV filters have shown potential for hormonal disruption in animal models. Exposure to EDCs during the prenatal period, even at low concentrations, can potentially affect the fetal programming of various systems, including the thyroid and reproductive organs. These disruptions may be associated with complications like changes in birth weight or developmental issues.

Official Guidance and Safer Sunscreen Choices

Major health organizations prioritize sun protection during pregnancy to mitigate the risks of skin cancer and melasma. The American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Dermatology (AAD) encourage pregnant individuals to use sun protection daily. However, due to the systemic absorption of chemical filters, many dermatologists and experts recommend a precautionary approach.

The consensus recommendation is to favor mineral-based sunscreens containing Zinc Oxide and Titanium Dioxide. These ingredients are considered non-systemic, meaning they sit on the skin surface and are not absorbed into the bloodstream, making them the preferred choice during pregnancy. In addition to using mineral sunscreen, pregnant individuals should employ other sun-safe practices:

  • Wearing wide-brimmed hats, sunglasses, and protective clothing.
  • Seeking shade during peak sun hours.

This combination minimizes potential chemical exposure while still ensuring adequate protection from harmful UV radiation.