GREEN BOOK 4 Alkyl Benzoates CIR EXPERT PANEL MEETING
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GREEN BOOK 4 Alkyl Benzoates CIR EXPERT PANEL MEETING AUGUST 30-31, 2010 July 30, 2010 MEMORANDUM To: CIR Expert Panel and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Subject: Draft Report for C12-15 Alkyl Benzoate and related Alkyl Benzoates The Cosmetic Ingredient Review (CIR) announced the Scientific Literature Review (SLR) for alkyl benzoates in June, 2010. C12-15 alkyl benzoate is the lead ingredient of this safety assessment. Related alkyl benzoate ingredients are included. CIR has been informed that a comprehensive dossier on the C12-15 alkyl benzoates being prepared for the European REACH program will be completed and provided to CIR in late September or early October. The Panel should review the Draft Report and decide: 1) if it is reasonable to include the other listed ingredients with C12-15 alkyl benzoate in this report and 2) whether any additional data are needed in order to reach a safety conclusion for C12-15 alkyl benzoates and the related ingredients. If no additional data are required, then the Panel may issue a Tentative Report. Alternatively, the Panel may choose to table the report to await the receipt of the dossier mentioned above. CIR Panel Book Page 1 CIR Panel Book Page 2 History of Alkyl Benzoates June, 2010 – SLR issued. August, 2010 - CIR Panel Book Page 3 Search Strategy for Benzoates EXPORATORY SEARCH: PUBMED: “alkyl benzoate” – 7 hits, 1 useful; CAS No. – 0 hits. Internet (Dogpile) – “alkyl benzoate” ‐ 1 MSDS FULL SEARCH: PUBMED: “lauryl alcohol” – 53 hits, 6 ordered. Learned that Valerie was doing this ingredient. “tridecyl alcohol” – 0 hits. CAS No. – 0 and 19 hits. 1 useful. “Amyl benzoate” ‐0 hits. CAS no – no hits. “benhyl benzoate” – 0 hits. CAS no – no hits. “Butyl Benzoate” – 9 hits, 1 useful. CAS no. – no hits. “Butyloctyl Benzoate” – 0 hits. No CAS no. “Ethyl Benzoate” – 44 hits, 4 useful. “Ethylhexyl Benzoate” – no hits. “Hexyldecyl Benzoate” – no hits. “Isobutyl Benzoate” – not hits. CAS no. – no hits. “939‐48‐0” OR “34364‐24‐4” OR “Lauryl/Myristyl Benzoate” OR “112‐53‐8” OR “Octyldodecyl Benzoate” OR ”2315‐68‐6” OR “10578‐34‐4” – 224 hits, 19 useful TOXNET: 68411‐27‐8 – 0 hits; 112‐53‐8 – 253 hits, 47 useful; 112‐70‐9 – 33 hits, 2 useful; 26248‐42‐0 ‐ 10 hits, 4 useful; 629‐76‐5 – 15 hits, 1 useful (already have); 2049‐96‐9 – 6 hits, 0 useful; “amyl alcohol” ‐ 798 hits, 86 + 64 hits so far; 103403‐38‐9 – no hits; 136‐60‐7 ‐ Butyloctyl Benzoate – no hits; butyloctyl alcohol – no hits; C16‐17 Alkyl Benzoate – no hits; palmyl alcohol – no hits; heptadecyl alcohol – no hits; 93‐89‐0 – 56 hits, 64‐17‐5 alcohol – 50000 hits, did not explore yet; Hexyldecyl Benzoate – no hits; Hexyldecyl Benzoate – No hits; 120‐50‐3 – 3 hits, 0 useful; 939‐48‐0 – 2 hits, 0 useful; 34364‐24‐4 – no hits, Isopropyl Benzoate – No hits; Isostearyl Benzoate – no hits; Lauryl/Myristyl Benzoate ‐ no hits; 112‐ 53‐8 [print toxnet] – 248 hits, 112‐53‐8 – 248 hits, 61 useful; 93‐58‐3 – 135 hits, 14 useful; Octyldodecyl Benzoate – no hits; Octyldodecyl Alcohol – no hits; 2315‐68‐6 – 7 hits, 2 useful; 10578‐34‐4 – no hits. EPA – HPV – One relevant report that included methyl benzoate. Data added to report under original citations. CIR Panel Book Page 4 Report Draft Report Alkyl Benzoates as used in Cosmetics August 30, 2010 The 2010 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A Hill, 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 F. Alan Andersen, Ph.D. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1101 17th Street, NW, Suite 412 " Washington, DC 20036-4702 " ph 202.331.0651 " fax 202.331.0088 " [email protected] CIR Panel Book Page 5 TABLE OF CONTENTS TABLE OF CONTENTS ........................................................................................................................................................... iii INTRODUCTION ....................................................................................................................................................................... 1 CHEMISTRY .............................................................................................................................................................................. 1 Definition and Structure .......................................................................................................................................................... 1 Physical and Chemical Properties ........................................................................................................................................... 1 Manufacture and Production ................................................................................................................................................... 1 Impurities ................................................................................................................................................................................ 2 Analytical Methods ................................................................................................................................................................. 2 USE .............................................................................................................................................................................................. 2 Cosmetic .................................................................................................................................................................................. 2 Non-Cosmetic .......................................................................................................................................................................... 2 GENERAL BIOLOGY ................................................................................................................................................................ 2 Absorption, Distribution, Metabolism, and Excretion ............................................................................................................. 2 Growth Inhibition .................................................................................................................................................................... 3 TOXICOLOGY ........................................................................................................................................................................... 3 Acute Toxicity ......................................................................................................................................................................... 3 Methyl Benzoate ................................................................................................................................................................. 3 Ethyl Benzoate .................................................................................................................................................................... 3 Isopropyl Benzoate ............................................................................................................................................................. 3 Isobutyl Benzoate ................................................................................................................................................................ 3 Short-Term Toxicity ................................................................................................................................................................ 3 Benzoic Acid and Sodium Benzoate ................................................................................................................................... 3 Subchronic Toxicity ................................................................................................................................................................ 3 Benzoic Acid ....................................................................................................................................................................... 3 Chronic Toxicity ..................................................................................................................................................................... 3 Sodium Benzoate ................................................................................................................................................................ 3 Ocular/Mucosal Irritation ........................................................................................................................................................ 3 Isostearyl Benzoate ............................................................................................................................................................. 3 Dermal Irritation ...................................................................................................................................................................... 3 Methyl Benzoate ................................................................................................................................................................. 3 Ethyl Benzoate .................................................................................................................................................................... 4 Propyl Benzoate .................................................................................................................................................................