ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of three methylxanthines, Caffeine, Theobromine, and Theophylline, as used in cosmetics. All of these ingredients are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the data relevant to the safety of these ingredients and concluded that Caffeine, Theobromine, and Theophylline are safe in cosmetics in the present practices of use and concentration described in this safety assessment.
ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) first published a safety assessment of Sodium Dehydroacetate and Dehydroacetic Acid in 1985. The Panel previously concluded that Sodium Dehydroacetate and Dehydroacetic Acid are safe as used in the present practices of use and concentration, as stated in that report. Upon re-review in 2003, the Panel reaffirmed the original conclusion, as published in 2006. The Panel reviewed updated frequency and concentration of use data again in 2023, in addition to any newly available, relevant safety data. Considering this information, as well as the information provided in the original safety assessment and the prior re-review document, the Panel reaffirmed the 1985 conclusion.
ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1982 and a previous re-review in 2002, along with updated information regarding product types and concentrations of use. Considering this information, the Panel confirmed that Laneth-9 Acetate and Laneth-10 Acetate are safe for topical application to humans in the present practices of use and concentration as described in this report.
Subject(s)
Acetates , Cosmetics , Animals , Humans , Acetates/toxicity , Acetates/pharmacokinetics , Consumer Product Safety , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Basic Red 76, which is reported to function in cosmetics as a hair colorant and hair-conditioning agent. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Basic Red 76 is safe for use as a hair dye ingredient in the present practices of use and concentration described in the safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics , Hair Dyes , Animals , Humans , Rats , Cosmetics/toxicity , Cosmetics/chemistry , Hair Dyes/toxicity , Hair Dyes/chemistry , Hair Dyes/pharmacokinetics , Risk Assessment , Toxicity TestsABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydrogen Peroxide for use in cosmetics. This ingredient is reported to function in cosmetics as an antimicrobial agent, cosmetic biocide, oral health care agent, and oxidizing agent. The Panel reviewed the data relevant to the safety of this ingredient and concluded that Hydrogen Peroxide is safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics , Hydrogen Peroxide , Hydrogen Peroxide/toxicity , Cosmetics/toxicity , Cosmetics/chemistry , Humans , Animals , Risk Assessment , Toxicity Tests , Oxidants/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polysilicone-11 as used in cosmetic formulations. This ingredient is reported to function as a film former. The Panel considered the available data and concluded that Polysilicone-11 is safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics , Cosmetics/toxicity , Cosmetics/chemistry , Humans , Animals , Risk Assessment , Toxicity Tests , Silicones/toxicity , Silicones/chemistryABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 28 soy-derived ingredients as used in cosmetic products. These ingredients are reported to primarily function as antioxidants, skin protectants, skin-conditioning agents, and hair-conditioning agents. The Panel considered the available data relating to the safety of these ingredients in cosmetic formulations, and concluded that 24 of the 28 soy-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel also concluded that the available data are insufficient to make a determination that Glycine Max (Soybean) Callus Culture, Glycine Max (Soybean) Callus Culture Extract, Glycine Max (Soybean) Callus Extract, and Glycine Max (Soybean) Phytoplacenta Conditioned Media are safe under the intended conditions of use in cosmetic formulations.
ABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Adenosine, Adenosine Phosphate, Adenosine Triphosphate, Disodium Adenosine Phosphate, and Disodium Adenosine Triphosphate. These ingredients are reported to function in cosmetics as skin-conditioning agents - miscellaneous. The Panel considered the available data and concluded that the five adenosine ingredients reviewed in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Subject(s)
Adenosine , Cosmetics , Adenosine/toxicity , Consumer Product Safety , Cosmetics/toxicity , Adenosine Triphosphate , Risk AssessmentABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in year 2000, along with updated information regarding product types and concentrations of use, and confirmed that PEG-5, -10, -16, -25, -30, and -40 Soy Sterol are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1982, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Choleth-24 is safe for topical applications to humans in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Humans , Polyethylene Glycols , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1982, along with updated information regarding product types and concentrations of use, and confirmed that Quaternium-18 and Quaternium-18 Bentonite are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
Subject(s)
Bentonite , Cosmetics , Bentonite/toxicity , Cosmetics/toxicity , Consumer Product SafetyABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1998, along with updated information regarding product types and concentrations of use and confirmed that EDTA and certain salts are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
Subject(s)
Cosmetics , Salts , Edetic Acid/toxicity , Cosmetics/toxicity , Consumer Product SafetyABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2007, along with updated information regarding product types and concentrations of use, and confirmed that Hexamidine and Hexamidine Diisethionate are safe as cosmetic ingredients in the practices of use and concentration as described in this report if used at concentrations less than or equal to .10%.
Subject(s)
Consumer Product Safety , Cosmetics , Benzamidines , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1985, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Chloroxylenol is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.
Subject(s)
Consumer Product Safety , Cosmetics , Xylenes/toxicity , Cosmetics/toxicityABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 8 dialkyl dimer dilinoleates as used in cosmetics. These ingredients are diesters formed from the reaction of straight-chained or branched alkyl alcohols and dilinoleic acid; these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel reviewed data relevant to the safety of these ingredients and concluded that Diisopropyl Dimer Dilinoleate, Dicetearyl Dimer Dilinoleate, Diisostearyl Dimer Dilinoleate, Diethylhexyl Dimer Dilinoleate, Dioctyldodecyl Dimer Dilinoleate, Ditridecyl Dimer Dilinoleate, Di-C16-18 Alkyl Dimer Dilinoleate, and Di-C20-40 Alkyl Dimer Dilinoleate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.
Subject(s)
Consumer Product Safety , Cosmetics , Cosmetics/toxicity , Alcohols , Risk AssessmentABSTRACT
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 21 parabens as preservatives in cosmetic products. All of these ingredients are reported to function in cosmetics as preservatives; however, 5 are reported to also function as fragrance ingredients. The Panel reviewed relevant data relating to the safety of these ingredients under the reported conditions of use in cosmetic formulations. The Panel concluded that 20 of the 21 parabens included in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment when the sum of the total parabens in any given formulation does not exceed 0.8%. However, the available data are insufficient to support a conclusion of safety for benzylparaben in cosmetics.
Subject(s)
Cosmetics/toxicity , Parabens/toxicity , Animals , Consumer Product Safety , Cosmetics/chemistry , Cosmetics/pharmacokinetics , Humans , Parabens/chemistry , Parabens/pharmacokinetics , Risk AssessmentABSTRACT
INTRODUCTION: Gastrostomy insertion either via radiological (radiologically inserted gastrostomy, RIG) or endoscopic (percutaneous endoscopic gastrostomy, PEG) approaches are widely practiced throughout Australia. The purpose of this study was to compare outcomes of inserted tubes and cost evaluation by both methods. METHODS: A retrospective cohort study conducted on all-cause gastrostomy insertions at a quaternary Australian Hospital, Royal Brisbane and Womens' Hospital (RBWH) between January 2012 and August 2015. Current referral pattern is first-line gastrostomy and second-line radiological insertion. RESULTS: A total of 402 gastrostomy tubes were inserted with a total of 307 PEG tubes and 95 RIG tubes, with follow-up to one calendar year. Mean patient age was 61 years ± 14.2 years with 76% male patients. A total of 84% of patients were head and neck cancer patients; major indications for insertion include prophylaxis (58%), dysphagia (32%) and NBM (2.5%). Patient groups were heterogeneous with varied indications for insertion including prophylaxis, dysphagia, decompression, NBM and treatment side effects. Outcomes measured included the following: complications, premature tube failure prior to expected removal and, overall tube outcome/ disposition. A lower incidence of minor complications was observed with the RIG group than the PEG group without differences in major complications over time. Tube failure due to either blockage or dislodgement was assessed. Multivariate analysis of all-cause dislodgement found 'method of insertion' a predictor of dislodgement with RIG 5.4(OR) times more likely to be dislodged than PEG. Competing risk analysis demonstrates equipment as a significant cause of dislodgement occurring more commonly with RIG than PEG tubes. Tubes were removed more often in the PEG group because a large volume were prophylactic. Tubes were replaced more often in the RIG group, with tube blockage and equipment as causes for tube replacement in this group. Replacements occur either in suite or bedside. Costing data were limited with only 94 patients' costing data qualifying for a limited unit cost evaluation, with radiologically inserted tubes marginally more expensive than tubes inserted endoscopically. CONCLUSIONS: Both are safe procedures, with improved techniques; radiologically inserted gastrostomies have an improved profile with respect to dislodgement rates than previously reported in the literature. Radiological tubes remain limited by equipment factors with balloon failure an ongoing issue. Cost analysis was hindered by poor documentation; however, the opportunity cost remains an important advantage of radiological insertion at peripheral sites, increasingly relevant for health service delivery in our geographically vast state.