The purpose of the study is to determine skin irritation and sensitization potential of a topical test article following repeated application. The results demonstrated no signs of irritation or sensitization in any of the test subjects throughout the study period. The mean irritation index was 0.00, indicating the complete absence of adverse dermatological responses.
These findings confirm that the Facial Wipes is safe for topical use, supporting the product claims “dermatologist tested,” “non-irritating,” “non-sensitizing,” “clinically tested” and “safe for sensitive skin.”
The trial was conducted in accordance with International Council on Harmonization Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and SkinScience Analytics (SSA) standard operating procedures. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training.
Assessment of a Test Article for Eye Irritation Potential by EpiOcular™ Eye Irritation Test (EIT)
The purpose of the study was to evaluate the ocular irritation potential of the test article using the EpiOcular™ Human Cell Construct in accordance with OECD Test Guideline 492. The results demonstrated that the test article, Full Face & Eye Wipes, did not exhibit ocular irritation potential under the conditions of this study. The mean tissue viability was 92.32%, which is above the 60% threshold required for classification as a non-irritant.
These findings confirm that the Full Face & Eye Wipes do not require classification or labeling for eye irritation (GHS No Category), supporting the product claims “Safe for Eyes.”
The trial is cruelty free and was conducted in accordance with OECD Test Guideline 492: Reconstructed Human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labeling for eye irritation or serious eye damage. No deviations from the study protocol were reported during the conduct of the study.
Assessment of a Test Article for Eye Irritation Potential by Ocular Instillation
Ocular safety and potential irritancy are critical factors in assessing the suitability
of cosmetic and personal care products for use around the eyes. Ocular instillation of a test product allows for a controlled evaluation of its impact on the delicate ocular tissues. By conducting this study with a diluted form of the test product, we aim to simulate real-life scenarios where products may encounter the eyes in a diluted or unintentional manner. This evaluation will provide valuable insights into the product's safety profile, aiding in formulating guidelines and recommendations for its safe usage. The ocular cul-de-sac is a highly sensitive area, especially in infants, making it susceptible to irritation and discomfort. Baby products, such as shampoos or lotions, can inadvertently encounter the eyes during routine use. Therefore, evaluating the ocular irritancy potential of such products, particularly in a diluted form, is essential to guarantee their gentle nature and adherence to "no tears" claims.
