Propylene Glycol Stearate
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Safety Assessment Dhivacosmetics Dhiva Shampoo
Cosmetic Product Safety Report Product name: Dhiva Shampoo Company name: Dhiva Cosmetics Version: 1 Formula number: Date: October 2016 Part A: Cosmetic Product Safety Information The following information is gathered and managed in the Dhiva Cosmetics product database (the product information file, PIF) under the relevant section. 1. Quantitative and qualitative composition of the cosmetic product, Dhiva shampoo composition (see Appendix A – Quantitative and qualitative composition of the cosmetic product): 2. Physical/chemical characteristics and stability of the cosmetic product: Stability clearance (see Appendix B – Stability summary). 3. Claim support: (no claim on this product). 4. Microbiological quality: Microbiological clearance (see Appendix B – Stability summary). 5. Impurities, traces, information about the packaging material: Packaging clearance (see Appendix B – Stability summary). 6. Normal and reasonably foreseable use: Label specifications (see below 2. Labelled warnings and instructions of use). 7. Exposure to the cosmetic product: (see Appendix C – Exposure assessment) and assessment below 8. Exposure to the substances: MoS calculation (see Appendix D – Margin of Safety calculations). 9. Toxicological profile of the substances (see Appendix E - Toxicological profiles for ingredients). 10. Undesirable effects and serious undesirable effects: Data from reports on (serious) undesireable effects (see Part B: Cosmetic Product Safety Assessment). 11. Information on the cosmetic product: User Test (see Appendix F – User test). Part B: Cosmetic Product Safety Assessment 1. Assessment conclusion The cosmetic product Dhiva Shampoo can be assessed as safe for normal and reasonably foreseeable use in accordance with the European Cosmetics Regulation (EC) No 1223/2009. 2. Labelled warnings and instructions of use The following warnings and instructions of use are mentioned on the packaging material/label of the product: Instructions of use: Massage into wet hair until it lathers. -
“Inert” Ingredients Used in Organic Production
“Inert” Ingredients Used in Organic Production Terry Shistar, PhD A Beyond Pesticides Report he relatively few registered pesticides allowed in organic production are contained in product formulations with so-called “inert” ingredients that are not disclosed on the T product label. The “inerts” make up the powder, liquid, granule, or spreader/sticking agents in pesticide formulations. The “inerts” are typically included in products with natural or synthetic active pesticide ingredients recommended by the National Organic Standards Board (NOSB) and listed by the National Organic Program (NOP) on the National List of Allowed and Prohibited Substances. Any of the pesticides that meet the standards of public health and environmental protection and organic compatibility in the Organic Foods Production Act (OFPA) may contain “inert” ingredients. Because the standards of OFPA are different from those used by the U.S. Environmental Protection Agency (EPA) to regulate pesticides and given changes in how the agency categorizes inerts, the NOSB has adopted a series of recommendations since 2010 that established a substance review process as part of the sunset review. NOP has not followed through on the Board’s recommendations and, as a result, there are numerous materials in use that have not been subject to OFPA criteria. This report (i) traces the history of the legal requirements for review by the NOSB, (ii) identifies the universe of toxic and nontoxic materials that make of the category of “inerts” used in products permitted in organic production, and (iii) suggests a path forward to ensure NOSB compliance with OFPA and uphold the integrity of the USDA organic label. -
Evidence of Systemic Toxic Effects
Safety Assessment of Monoalkylglycol Dialkyl Acid Esters as Used in Cosmetics Status: Scientific Literature Review for Public Comment Release Date: October 6, 2016 Panel Meeting Date: December 5-6, 2016 All interested persons are provided 60 days from the above date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. Lillian J. Gill. The 2016 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 Washington, DC 20036-4702 ph 202.331.0651 fax 202.331.0088 [email protected] INTRODUCTION This is a review of the available scientific literature and unpublished data relevant to assessing the safety of 31 monoalkylglycol dialkyl acid esters as used in cosmetics (Table 1). -
Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate
1 Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate Glycol Stearate, Glycol Stearate SE, and Glycol Distearate consist primarily of the mono- and diesters of triple-pressed stearic acid. They are used in numerous categories of cosmetic products at concentrations ranging from less than 0.1 to 10%. Animal data for acute oral toxicity, skin and eye irritation, and sensitiza tion show that these ingredients have low acute toxicity. A repeated insult patch test with 50% Glycol Distearate on 125 subjects presented no evidence of skin irritation or hypersensitivity. Human studies using formulations con taining Glycol Stearate at levels of 2—5% reported no skin irritation or sensitiza tion. Subchronic testing has not been adequately investigated in laboratory animals. Human test data for formulations containing > 4% Glycol Stearate or Glycol Distearate should be considered. Based on the available information presented herein, it is concluded that Glycol Stearate, Glycol Stearate SE, and Glycol Distearate are safe as cosmetic ingredients in the present practices of use and concentration. CHEMICAL AND PHYSICAL PROPERTIES hese ingredients are mixed esters of ethylene glycol and triple-pressed stearic T acid. The latter consists of 42.5 Io stearic acid and about an equal amount of palmitic acid, along with lesser amounts2of several other fatty acids. The general structural formula for these ingredients is:’ H2C-O-R1 H2C-O-R Glycol Stearate: The ingredient is comprised of 40—70°!0 of the monoester in which R1 is the acyl portion of triple-pressed stearic acid and R2 is H. Glycol 1 _________ 2 COSMETICINGREDIENTREVIEW ASSESSMENT:GLYCC Stearate also contains a significant portion, 3O—58%, of the diester in which both TABLE 1.