Safety Assessment of Alpha Hydroxy Acids as Used in Cosmetics PDF
Preview Safety Assessment of Alpha Hydroxy Acids as Used in Cosmetics
Safety Assessment of Alpha Hydroxy Acids as Used in Cosmetics Status: Re-Review for Panel Review Release Date: November 15, 2013 Panel Meeting Date: December 8-9, 2013 The 2013 Cosmetic Ingredient Review Expert Panel members are: Chairman, 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 re-review document was prepared by Monice M. Fiume, Senior 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] Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: November 15, 2013 Subject: Re-Review of Alpha Hydroxy Acids as Used in Cosmetics The re-review of Alpha Hydroxy Acids (AHAs) as used in cosmetics is being presented to the Panel. In 1998, the Panel concluded that glycolic and lactic acid, their common salts and their simple esters, are safe for use in cosmetic products at concentrations ≤10%, at final formulation pH ≥3.5, when formulated to avoid increasing sun sensitivity or when directions for use include the daily use of sun protection. These ingredients are safe for use in salon products at concentrations ≤30%, at final formulation pH ≥3.0, in products designed for brief dis- continuous use followed by thorough rinsing from the skin, when applied by trained professionals, and when application is accompanied by directions for the daily use of sun protection. The Discussion of the report focused on three main area of concern: the known irritation potential, the potential enhancement of penetration of other ingredients, and the potential increase in sensitivity to sunlight. Because it has been 15 years since the report was published, the Panel is being asked to determine whether there is any reason to re-open the safety assessment of these ingredients, or, if the conclusion should be reaffirmed. No ingredients are being suggested as “add-ons” for inclusion in this review. TEA-lactate was re-reviewed in 2013 as part of the CIR safety assessment of triethanolamine and triethanol- amine-containing ingredients as used in cosmetics. The Panel concluded that TEA-lactate, as part of that report, is safe as used when formulated to be non-irritating and when the levels of free diethanolamine do not exceed the present practices of use and concentration found safe for diethanolamine itself, and it should not be used in cosmetic products in which N-nitroso compounds can be formed. TEA-lactate was reported to be used at 0.06% in leave-on formulations, and the highest reported concentration of use of triethanolamine in a leave-on product was 6%. The use of AHAs in cosmetic formulations has increased remarkably over the past 15 years. In the original 1998 safety assessment, glycolic acid was reported to be used in 42 formulations and lactic acid in 342 formulations. According to 2013 VCRP data, glycolic acid is now used in 337 formulations and lactic acid in 1042 formulations. Concentration of use data were received from the Council and incorporated in the report. Most of the reported concentrations of use adhere to the concentration limitation set forth in the original report. However, a few exceptions are noted: glycolic acid is reported to be used up to 50% in face and neck products and in skin cleansing preparations (but concentrations for all other categories report use at ≤10%); ethyl lactate is used at 95% in “other” manicuring formulations and at 50% in nail polish and enamel removers; and myristyl lactate is used at up to 13.2% in lipstick formulations. __________________________________________________________________________________________ 1101 17th Street, NW Suite 412, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distrbuted for comment only -- do not cite or quote A search of the published literature was conducted, and all relevant papers were obtained. For the initial evalua- tion of this re-review document by the Panel, those references are listed at the end of the report, and only a summarization of significant new data is included in text. Finally, the original safety assessment is being provided to you as part of this re-review package. For those of you that were Panel members at the time of the original review, you will recall that the assessment of this ingredient family was very thorough and the discussions were very robust. The minutes from all the Panel meetings at which the safety of these ingredients was deliberated are being included so that you have a complete history. Distrbuted for comment only -- do not cite or quote Distrbuted for comment only -- do not cite or quote Alpha Hydroxy Acids Re-Review History December 9-10, 2013: Re-Review In 1998 the CIR published the report with the conclusion: The Panel concluded that glycolic and lactic acid, their common salts and their simple esters, are safe for use in cosmetic products at concentrations ≤10%, at final formulation pH ≥3.5, when formulated to avoid increasing sun sensitivity or when directions for use include the daily use of sun protection. These ingredients are safe for use in salon products at concentrations ≤30%, at final formulation pH ≥3.0, in products designed for brief discontinuous use followed by thorough rinsing from the skin, when applied by trained professionals, and when applica- tion is accompanied by directions for the daily use of sun protection. No add-on ingredients are proposed. Distrbuted for comment only -- do not cite or quote Alpha Hydroxy Acids Data Profile* – Dec 2013 – Monice Fiume Reported Use Method of Mfg Impurities Toxicokinetics Animal Tox – Acute, Dermal Animal Tox – Acute, Oral Animal Tox, Acute, Inhalation Animal Tox – Rptd Dose, Derm Animal Tox, Rptd Dose, Oral Animal Tox – Rptd Dose, Inhal Repro/Dev Tox Genotox Carcinogenicity Dermal Irr/Sens Phototoxicity Ocular Irritation ORIGINAL REPORT Glycolic Acid X X X X X X X X X X X X X Ammonium Glycolate X Calcium Glycolate Potassium Glycolate X Sodium Glycolate X X X X X X Methyl Glycolate Ethyl Glycolate X Propyl Glycolate Butyl Glycolate Lactic Acid X X X X X X X X X X X X X Ammonium Lactate X X X X X X X Calcium Lactate X X X Potassium Lactate X X X Sodium Lactate X X X X X X X X X TEA-Lactate X Methyl Lactate X X Ethyl Lactate X X X X X X Isopropyl Lactate Butyl Lactate X X X X Lauryl Lactate X X X X Myristyl Lactate X X X X X X Cetyl Lactate X X X X X X X Distrbuted for comment only -- do not cite or quote Alpha Hydroxy Acids Data Profile* – Dec 2013 – Monice Fiume Reported Use Method of Mfg Impurities Toxicokinetics Animal Tox – Acute, Dermal Animal Tox – Acute, Oral Animal Tox, Acute, Inhalation Animal Tox – Rptd Dose, Derm Animal Tox, Rptd Dose, Oral Animal Tox – Rptd Dose, Inhal Repro/Dev Tox Genotox Carcinogenicity Dermal Irr/Sens Phototoxicity Ocular Irritation Re-Review Glycolic Acid X X X X Ammonium Glycolate X Calcium Glycolate Potassium Glycolate Sodium Glycolate X Methyl Glycolate Ethyl Glycolate Propyl Glycolate Butyl Glycolate Lactic Acid X X Ammonium Lactate X Calcium Lactate X Potassium Lactate X Sodium Lactate X TEA-Lactate X Methyl Lactate X Ethyl Lactate X X Isopropyl Lactate Butyl Lactate X X Lauryl Lactate X Myristyl Lactate X Cetyl Lactate X *“X” indicates that data were available in a category for the ingredient Distrbuted for comment only -- do not cite or quote Glycolic Acid 79-14-1 Ammonium Glycolate 35249-89-9 Calcium Glycolate – not in Dictionary; not in CosIng Potassium Glycolate – 1932-50-9 - not in Dictionary; not in CosIng Sodium Glycolate 2836-32-0 Methyl Glycolate – not in Dictionary; not in CosIng Ethyl Glycolate – not in Dictionary; not in CosIng Propyl Glycolate - not in Dictionary; not in CosIng Butyl Glycolate 7397-62-8 Lactic Acid 50-21-5; 79-33-4 Ammonium Lactate 515-98-0; 52003-58-4 Calcium Lactate 5743-47-5; 814-80-2 Potassium Lactate 85895-78-9; 996-31-6 Sodium Lactate 72-17-3; 867-56-1 TEA-Lactate 20475-12-1 Methyl Lactate 27871-49-4; 547-64-8 Ethyl Lactate 97-64-3 Isopropyl Lactate – 63697-00-7 - not in Dictionary Butyl Lactate 138-22-7 Lauryl Lactate 6283-92-7 Myristyl Lactate 1323-03-1 Cetyl Lactate 35274-05-6 Distrbuted for comment only -- do not cite or quote PubMed Search – 10/4,7/13 (alpha AND hydroxy AND acid) OR (Glycolic AND Acid) OR ((Ammonium OR Calcium OR Potassium OR Sodium OR Methyl OR Ethyl OR Propyl OR Butyl) AND Glycolate) OR (Lactic AND Acid) OR ((Ammonium OR Calcium OR Potassium OR Sodium OR Triethanolamine OR Methyl OR Ethyl OR Isopropyl OR Butyl OR Lauryl OR Myristyl OR Cetyl) AND Lactate) AND (SENSITIZ* OR SENSITIS* OR PHOTOTOX* OR IRRITA* OR PHOTOSENS*) - 648 AND (CARCINOGEN* OR MUTAGEN* OR GENTOX* OR CLASTOGEN* * OR (TUMOR AND (PROMOT* OR INITIAT*))) - 1488 AND ((DERMAL OR ORAL) AND TOXIC*) OR ((REPRODUC* OR DEVELOP*) AND TOX*) OR TOXICOKINETIC* OR (DERMAL AND (ABSORB* OR ABSORP* OR PENETRAT*)) OR ((UV OR ULTRAVIOLET) AND (ABSORP* OR ABSORB*)) - 1184 – ALL FROM 1995 on - 38 papers ordered EU CosIng Database – 10/8/13 Glycolic Acid – SCCP position paper (on AHAs) no restrictions: Ammonium, Sodium, and Butyl Glycolate not listed: Calcium and Potassium Glycolate; Methyl, Ethyl, and Propyl Glycolate Lactic Acid – SCCP position paper (on AHAs) no restrictions: Ammonium, Calcium, Potassium, and Sodium Lactate; Butyl, Cetyl, Lauryl, and Myristyl Lactate TEA-Lactate: III/62 – Trialkyalmines, trialkanolamines, and their salts – see website for restrictions not listed: Isopropyl Lactate IARC – 10/8/13 nothing NTP – 10/8/13 Glycolic Acid – photocarc study; repro effects of ethylene glycol Glycolate – nothing Lactic Acid – nothing Lacatate – nothing OECD – 10/8/13 Lactic Acid – OECD; EPA/HPV no others REACH – 10/11/13 Glycolic Acid - http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d9b67cf-6aee-3ac1-e044-00144f67d249/DISS- 9d9b67cf-6aee-3ac1-e044-00144f67d249_DISS-9d9b67cf-6aee-3ac1-e044-00144f67d249.html Butyl Glycolate: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9875a518-a596-53d8-e044-00144f67d031/DISS- 9875a518-a596-53d8-e044-00144f67d031_DISS-9875a518-a596-53d8-e044-00144f67d031.html Lactic Acid - http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d9206e2-b2f0-4755-e044-00144f67d249/DISS- 9d9206e2-b2f0-4755-e044-00144f67d249_DISS-9d9206e2-b2f0-4755-e044-00144f67d249.html L-(+)-Lactic Acid: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d98ad08-1f3b-2a26-e044- 00144f67d249/DISS-9d98ad08-1f3b-2a26-e044-00144f67d249_DISS-9d98ad08-1f3b-2a26-e044-00144f67d249.html (R)-Lactic Acid: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eae9ea1-66a7-0563-e044-00144f67d031/DISS- 9eae9ea1-66a7-0563-e044-00144f67d031_DISS-9eae9ea1-66a7-0563-e044-00144f67d031.html Sodium Lactate: http://apps.echa.europa.eu/registered/data/dossiers/DISS-dcd6f8da-a5c7-4638-e044-00144f67d031/DISS- dcd6f8da-a5c7-4638-e044-00144f67d031_DISS-dcd6f8da-a5c7-4638-e044-00144f67d031.html Sodium (S)-Lactate: http://apps.echa.europa.eu/registered/data/dossiers/DISS-dffb4072-e40a-47ae-e044- 00144f67d031/DISS-dffb4072-e40a-47ae-e044-00144f67d031_DISS-dffb4072-e40a-47ae-e044-00144f67d031.html Methyl (R)-Lactate: http://apps.echa.europa.eu/registered/data/dossiers/DISS-db9c1296-a884-2ccf-e044- 00144f67d031/DISS-db9c1296-a884-2ccf-e044-00144f67d031_DISS-db9c1296-a884-2ccf-e044-00144f67d031.html Distrbuted for comment only -- do not cite or quote Methyl (S)-(-)-Lactate: http://apps.echa.europa.eu/registered/data/dossiers/DISS-db9a2343-9144-33e1-e044- 00144f67d031/DISS-db9a2343-9144-33e1-e044-00144f67d031_DISS-db9a2343-9144-33e1-e044-00144f67d031.html ChemPortal – 10/11/13 Glycolic Acid: HPVIS: http://ofmpub.epa.gov/oppthpv/quicksearch.display?pChem=100316 SIDS – no IUCLID: http://esis.jrc.ec.europa.eu/doc/IUCLID/data_sheets/79141.pdf Butyl Glycolate: IUCLID: http://esis.jrc.ec.europa.eu/doc/IUCLID/data_sheets/7397628.pdf SIDS: no Lactic Acid: SIDS – initial profile: http://webnet.oecd.org/Hpv/UI/handler.axd?id=240da177-beeb-4c99-b716-355be7dd4637 EPA HPV: http://www.epa.gov/chemrtk/hpvis/rbp/Lactic%20Acid_Web_SuppDocs_August%202008.pdf IUCLID – no Sodium Lactate: IUCLID: Sodium (S)-Lactate: http://esis.jrc.ec.europa.eu/doc/IUCLID/data_sheets/867561.pdf SIDS – no
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