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Alkyl Benzoates CIR EXPERT PANEL MEETING DECEMBER 13-14, 2010

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Alkyl Benzoates CIR EXPERT PANEL MEETING DECEMBER 13-14, 2010 Alkyl Benzoates CIR EXPERT PANEL MEETING DECEMBER 13-14, 2010 ADMINISTRATIVE November 11, 2010 MEMORANDUM To: CIR Expert Panel and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Subject: Draft Tentative Report for C12-15 Alkyl Benzoate and related Alkyl Benzoates The Cosmetic Ingredient Review (CIR) Expert Panel issued an Insufficient Data Announcement (IDA) for C12- 15 alkyl benzoate and related benzoates (17 total ingredients) in August. The data needs are: 1) dermal penetration data, especially on ingredients smaller than C12-C15 alkyl benzoates; if there is possible dermal penetration then 2) reproduction and developmental toxicity; 3) carcinogenicity; and 4) irritation and sensitization data on ingredients smaller than C12-C15 alkyl benzoates. CIR was informed that a comprehensive dossier on the C12-15 alkyl benzoates is being prepared for the European REACH program and that it would be provided to CIR in late September or early October. The project is behind schedule and is projected to be ready in January, 2011. Data were provided by the Personal Care Products Council and have been inserted into the report. There are now data on dermal penetration and those data do include the smallest MW ingredient, methyl benzoate, and there are irritation and sensitization data. No data on reproduction/developmental toxicity, however, are available, except for sodium benzoate and several alcohol metabolites and no data are available on carcinogenicity, except for benzoic acid and several alcohol metabolites. A few of the larger submissions that had more detail than necessary (e.g., raw data, informed consent forms) have had some pages removed in the print version of the Panel book. If these data are necessary for evaluation, you may examine the removed pages in the online version. As requested, the available data on alcohols that have been reviewed by the Panel and RIFM have been summarized and included in the report. The Panel should review the Draft Tentative Report and decide if the additional data address the data needs of the IDA. If the data are sufficient, then the Panel needs to adjust the safety conclusion. If not, then the Panel may decide to 1) issue a Tentative Report with an insufficient data conclusion or 2) table the report to give industry the additional opportunity to include the data being prepared for REACH and other data on the smaller alkyl benzoates. History of Alkyl Benzoates June, 2010 – SLR issued. August, 2010 – The Panel issued an Insufficient Data Announcement. The data needs are: 1) dermal penetration data, especially on ingredients smaller than C12-C15 alkyl benzoates; if there is possible dermal penetration then 2) reproduction and developmental toxicity; 3) carcinogenicity; and 4) irritation and sensitization data on ingredients smaller than C12-C15 alkyl benzoates. There is a REACH submission being prepared that is going to be shared with CIR. It was expected before the December meeting. It has been delayed and is not in the December report. Some of the data have been submitted through PCPC and is included in the report. The Panel decided to issue an Insufficient Data Announcement instead of tabling the report to wait for the REACH data to move the report along the process and to officially identify data needs. 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. Alkyl Benzoate Data Profile for December, 2010. Writer ‐ Lillian Becker Repeated dose ADME Acute toxicity Irritation Sensitization toxicity Penetration Dermal Log Use Oral Dermal Inhale Oral Dermal Ocular Animal Dermal Dermal Human Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale K ow Irritation Irr. Irr methyl benzoate X X X X X X X X X X X ethyl benzoate X X X X X X X X X X X propyl benzoate X X X butyl benzoate X X X X X X X amyl benzoate X X X lauryl/myristyl x benzoate C12-15 alkyl X X X X X X X X X X X benzoate C16-17 alkyl X benzoate stearyl benzoate X X behenyl benzoate X isopropyl X X X X X X benzoate isobutyl benzoate X X x X X X X isostearyl X X X X benzoate ethylhexyl X X H X X benzoate butyloctyl X benzoate hexyldecyl X benzoate octyldodecyl x x x benzoate H – Only human data TRANSCRIPTS/MINUTES working on it, when we're done, what do we have? decide is there enough information to proceed with One ingredient. So, we're going to wait until we a tentative report or do we need an insufficient have the -- back to having toxicology expertise data notice? before we go down this route. DR. BERGFELD: Are there promised data DR. MARKS: Okay. Shall we move on? on this particular ingredient? DR. SHANK: I like the structure given DR. MARKS: The only promised data, I for wheat, ginger root, cucumber. think, is what I see in front here from Lillian MR. BAILEY: I would just inject at this just came, on HRIPT on benzoate esters. time that we will take this table and alert the MS. BECKER: There is also a submission industry that these are coming up and, you know, being prepared for the REACH program that has been to anticipate concentration of use. But we'll promised later this year, that's been promised to need to make sure that we know when those reports be substantial and increase the amount of data in are started so that we can get the timing right, the report. So, we have the option of tabling and because the timing is much shorter than it used to waiting for it, or proceeding with what we have be and we want to make sure we get the information and tabling in December if it doesn't show up. in time for the reviews. DR. SLAGA: How detailed are the REACH DR. ANDERSEN: (off mic) people? I have no idea. DR. MARKS: Thank you, John. Next MS. BECKER: I haven't seen -- ingredient is the Green Book on alkyl benzoates. DR. ANDERSEN: Detailed with a capital This is a draft report for C12-15, alkyl benzoate "D." and related alkyl benzoates, and this is the first DR. SLAGA: I say we should wait and time we've seen this report. So now we need to table. MS. BECKER: You can also -- I'm sorry, and we would be positioned to move forward with a you can also make a determination now and the tentative decision in December. stuff will be in the December report and continue To some extent it's moot because all of to move on, where if you table it now, it will be -- there's no way this can't get wrapped up in starting from this point now in December instead 2011. We're not -- there's no way to get it of moving on for the (inaudible) meeting. So, wrapped up in 2010. So, I'm spitting in the wind whichever you feel is appropriate and beneficial to some extent, but I still want to be pushy about for everybody. the idea of moving things forward expeditiously. DR. ANDERSEN: I think my concern is But I won't be hugely upset if you think tabling just keeping the freight moving. If we table it is the better approach. now, then it's in a holding pattern, we come back DR. MARKS: I guess it depends how long in December, and suppose there are one or two the laundry list is we have now versus maybe the pieces of data that are needed, then we're just, (inaudible) will answer it. But I hear you, Alan, at that point, issuing an insufficient data in terms of this at least gets us thinking of what announcement, albeit at that point in time a much data do we need if we issue an insufficient data better informed announcement because we have what announcement.
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