Unlabelled: Purpose/Aim: The U.S. Food and Drug Administration (FDA) does not require specific testing to demonstrate the safety of personal care and cosmetic products or their ingredients. Recently, there have been reports of skin irritation associated with the use of commercially available cleansing conditioners. The goal of this study was to implement a tier-based safety assessment to evaluate the skin irritation potential of six commercially available cleansing conditioners and their ingredients.
Materials And Methods: The first tier of testing utilized the Organization for Economic Co-operation and Development (OECD) QSAR Toolbox to perform an in silico evaluation of the skin irritation potential of the product ingredients, and the second tier of testing utilized an OECD in vitro guideline test to evaluate the skin irritation potential of each product.
Results: Thirty-two ingredients were evaluated using the OECD QSAR Toolbox profiler for the tier one analysis; nine ingredients received a structural alert for skin irritation/corrosion. In the tier two in vitro analysis, the evaluated cleansing conditioner products were all classified as non-irritants.
Conclusions: These results provide evidence that use of the evaluated commercially available cleansing conditioners would not be expected to cause skin irritation among consumers. Additionally, this study demonstrates that the presence of structural alerts does not always accurately predict the safety of a product, as focused tier-based testing is necessary to comprehensively evaluate a product. This study illustrates a tier-based safety assessment approach, applicable to a wide variety of health endpoints, which efficiently and adequately evaluates the safety of personal care and cosmetic products and their ingredients.
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http://dx.doi.org/10.1080/15569527.2018.1512610 | DOI Listing |
Int J Pharm
December 2024
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, October 6 University, Giza, Egypt.
Oleic acid liposomes (OALs) are novel vesicular carriers ofunsaturated fatty acids and their corresponding ionized species, arranged within an enclosed lipid bilayer. This study aimed to encapsulate moxifloxacin HCl (MOX), a broad-spectrum antibacterial drug into OALs for effective treatment of Methicillin-resistant Staphylococcus aureus (MRSA) infection through topical application. Various OALs were formulatedby combining varied quantities of phosphatidylcholine (PC), oleic acid (OA), and cholesterol (CH) with 50 mg of MOX.
View Article and Find Full Text PDFExpert Opin Drug Saf
December 2024
Department of Dermatology, Third Xiangya Hospital, Central South University, Changsha, China.
Background: Ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, is a widely used treatment for various dermatological diseases. This study employs the FDA Adverse Event Reporting System (FAERS) database to examine adverse events (AEs) associated with ruxolitinib cream.
Methods: This study employed disproportionate analysis methods, including reported odds ratio and proportional reporting ratio, to collate AEs reported from the fourth quarter of 2021 to the first quarter of 2024.
Qual Life Res
December 2024
Department of Health Policy, Corvinus University of Budapest, 8 Fővám Square, Budapest, Hungary, 1093.
Objectives: Limited evidence is available about the content validity of the EQ-5D-5L in rare skin fragility disorders. Previous research has demonstrated that the skin irritation and self-confidence additional dimensions (bolt-ons) improve the content validity of the EQ-5D-5L in psoriasis and atopic dermatitis. Our aim was to investigate the content validity of the EQ-5D-5L and the two bolt-ons in Darier's disease and Hailey-Hailey disease.
View Article and Find Full Text PDFOphthalmic Plast Reconstr Surg
December 2024
Adnexal Department, Moorfields Eye Hospital, NHS Foundation Trust, London, United Kingdom.
Purpose: Euryblepharon is a rare congenital eyelid malformation characterized by symmetrical horizontal enlargement of the palpebral fissure. The eyelid is shortened vertically compared with the horizontal dimension. The lateral canthus is most commonly affected.
View Article and Find Full Text PDFFollowing a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 41028 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 10 colony forming units (CFU)/kg fresh plant material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.
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