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DEA) and Related DEA-Containing Ingredients GREEN Diethanolamine (DEA) and Related DEA-Containing Ingredients CIR EXPERT PANEL MEETING MARCH 3-4, 2011 Memorandum To: CIR Expert Panel Members and Liaisons From: Monice M. Fiume MMF Senior Scientific Analyst/Writer Date: February 10, 2011 Subject: Re-Review of Diethanolamine (DEA) and Related DEA-Containing Ingredients At the December Panel meeting, the Panel made the decision to reopen the safety assessment of Triethanolamine (TEA), Diethanolamine, and Monoethanolamine (MEA). That decision was based on the need to incorporate new data, but most importantly, on the benefit of separating the ethanolamines, and having each of these ingredients be in its own report with a family of related ingredients created for each. The re-review of DEA and 68 DEA-containing ingredients is being submitted for your review. In considering the potential safety issues with DEA-containing ingredients, it was reasoned that, were they to penetrate the skin, the toxicity of most concern would be the DEA moiety. The acid salt ingre- dients, DEA Myristate, for example, would be expected to dissociate into DEA and the corresponding acid. The covalent DEA ingredients, such as cocamide DEA, do not readily dissociate into DEA and the other component. However, in the case of these covalent ingredients, DEA may be of concern as an impurity and/or metabolite. Since this is the first time the groupings are being presented to the Panel, there is an opportunity to make a further determination whether this family of ingredients is appropriate as currently grouped. If it is not, the Panel can make changes. The safety of 8 of the ingredients included in this re-review, as currently grouped, has been reviewed previously by the CIR. Summary information from the existing safety assessments is included in the current re-review document. Additionally, many of the ingredients included in this re-review include a component that has been reviewed by the CIR. For example, DEA-Isostearate is the DEA salt of isostearic acid; isostearic acid has been reviewed by the CIR. Table 2 provides the conclusions from the CIR reports on all the component ingredients. Finally, many of the ingredients are lacking safety data. The Panel should consider any existing CIR reports that can be used to determine the safety of ingredients that dissociate. For those that do not dissociate, the Panel should consider whether the impurity level of DEA can be used as a determining factor in considering safety. As a reminder, NTP studies have results indicating clear evidence of carcinogenicity in mice for DEA and some DEA fatty acid esters. The Panel determined that the mode of action of DEA carcinogenesis in mice was understood and the penetration was sufficiently well-characterized, such that the carcinogeni- city findings in mice were considered to have no relevance to human health from the use of cosmetics containing DEA. This re-review is the first of the three ethanolamine reports being presented. The re-reviews on TEA and MEA will be presented at later meetings. Also included for your review are previous CIR reports about ingredients discussed in this report. Panel Book Page 1 TEA, DEA, MEA HISTORY Original Report: In 1983, the Expert Panel determined that these ingredients were safe for use in cosmetic formulations designed for discontinuous, brief use followed by thorough rinsing from the surface of the skin. In products intended for prolonged contact with the skin, the concentration of ethanolamines should not exceed 5%. Ethanolamine (MEA) should be used only in rinse-off products. Triethanolamine (TEA) and diethanolamine (DEA) should not be used in products containing N-nitrosating agents. June 1999: discussed NTP carcinogenicity results; presentations were made by Dr. Lehman- McKeeman and Dr. Stott June 2008: presentation was made by Dr. Stott; Acetamide MEA was discussed, with reference to the MEA, DEA, TEA report June 2009: discussed DEA carcinogenicity; the DEA report was not be reopened December 2010: formal rereview package was presented to the Panel; report was split into 3 separate documents – DEA, TEA, and MEA, add additional ingredients will be added to each report March 2011: the RR of DEA was presented to the Panel, including the new ingredient subgroups Panel Book Page 2 DEA Family Data Profile* – March 2011 – Writer, Monice Fiume – – – – genicity Previously Reviewed on Review CIR Component Reported Use DEA Free Content log P value Toxicokinetics Data Tox Animal Dermal Acute, Tox Animal Oral Acute, Tox,Animal Acute, Inhalation Tox Animal Rptd Dose, Dermal Tox,Animal Rptd Dose, Oral Tox Animal Rptd Dose, Inhalation Repro/Dev Tox Genotoxicity Carcino Dermal Irr/Sens Ocular Irritation DEA X X X X X X X X X X X X X Inorganic Acid Salt Diethanolamine Bisulfate X Organic Acid Salts DEA-Isostearate DEA- Isostearate X DEA-Lauraminopropionate DEA-Linoleate X DEA-Myristate X DEA Stearate X X Organo-Substituted Inorganic Acid Salts DEA-C12-13 Alkyl Sulfate DEA-C12-13 Pareth-3 Sulfate X DEA-C12-15 Alkyl Sulfate DEA-Ceteareth-2 Phosphate X DEA-Cetyl Phosphate DEA-Cetyl Sulfate X DEA-Di(2-Hydroxypalmityl)Phosphate X DEA-Dodecylbenzenesulfonate X DEA-Hydrolyzed Lecithin X DEA-Laureth Sulfate X X DEA-Lauryl Sulfate X X DEA-Methyl Myristate Sulfonate X DEA-Myreth Sulfate X DEA-Myristyl Sulfate X DEA-Oleth-3 Phosphate X DEA-Oleth-5 Phosphate DEA-Oleth-10 Phosphate X DEA-Oleth-20 Phosphate Alkyl Substituted Diethanolamines Butyl Diethanolamine N-Lauryl Diethanolamine X Methyl Diethanolamine X X X X X X X X X X Panel Book Page 3 DEA Family Data Profile* – March 2011 – Writer, Monice Fiume – – – – genicity Previously Reviewed on Review CIR Component Reported Use DEA Free Content log P value Toxicokinetics Data Tox Animal Dermal Acute, Tox Animal Oral Acute, Tox,Animal Acute, Inhalation Tox Animal Rptd Dose, Dermal Tox,Animal Rptd Dose, Oral Tox Animal Rptd Dose, Inhalation Repro/Dev Tox Genotoxicity Carcino Dermal Irr/Sens Ocular Irritation Diethanolamides Almondamide DEA X Apricotamide DEA X Avocadamide DEA X Babassuamide DEA X Behenamide DEA X Capramide DEA X X Cocamide DEA X X X X X X X X X X Cocoyl Sarcosinamide DEA X Cornamide DEA X Cornamide/Cocamide DEA X DEA-Cocoamphodipropionate X Diethanolaminooleamide DEA Hydrogenated Tallowamide DEA X Isostearamide DEA X X X X Lactamide DEA X Lanolinamide DEA X Lauramide DEA X X X X X X X X X X X X X X Lauramide/Myristamide DEA X X Lecithinamide DEA X Linoleamide DEA X X X X X X X X Minkamide DEA X Myristamide DEA X X X X X Oleamide DEA X X X X X X X X X X X Olivamide DEA X Palm Kernelamide DEA X X Palmamide DEA X Palmitamide DEA X X PEG-2 Tallowamide DEA X PEG-3 Cocamide DEA X Ricebranamide DEA X Ricinoleamide DEA X X X Sesamide DEA X Shea Butteramide/Castoramide DEA X Soyamide DEA X X Stearamide DEA X X X X X X X X Panel Book Page 4 DEA Family Data Profile* – March 2011 – Writer, Monice Fiume – – – – genicity Previously Reviewed on Review CIR Component Reported Use DEA Free Content log P value Toxicokinetics Data Tox Animal Dermal Acute, Tox Animal Oral Acute, Tox,Animal Acute, Inhalation Tox Animal Rptd Dose, Dermal Tox,Animal Rptd Dose, Oral Tox Animal Rptd Dose, Inhalation Repro/Dev Tox Genotoxicity Carcino Dermal Irr/Sens Ocular Irritation Stearamide DEA-Distearate X Stearamidoethyl Diethanolamine Stearamidoethyl Diethanolamine HCl Tallamide DEA X Tallowamide DEA Undecylenamide DEA X X Wheat Germamide DEA X *“X” indicates that data were available in a category for the ingredient Panel Book Page 5 DEA Search Info NLM EU FDA ChemPortal conc Toxline- Misc ECE- IUCLID # uses NTIS Registry NTIS Merck EU SCCS SIDS IARC NTP EAFUS OTC HPVIS data Pubmed NLM TOC data set date searched 1-7&12-11 11-23 1/11 1-25-11 1-25 1-25 1-25-11 1-25-11 DEA x x II x x x 111-42-2 DEA Bisulfate x II 59219-56-6 DEA-Myristate x II 53404-39-0 DEA Stearate no DEA-Isostearate II DEA-Linoleate x II 59231-42-4 DEA-Lauraminopropionate x II 65104-36-1 DEA-Lauryl Sulfate x II 143-00-0 DEA-C12-13 Alkyl Sulfate II DEA-Myristyl Sulfate x II 65104-61-2 DEA-C12-15 Alkyl Sulfate II DEA-Cetyl Sulfate x II 51541-51-6 DEA-Laureth Sulfate 392 35 x II 58855-36-0 DEA-C12-13 Pareth-3 Sulfate II DEA-Myreth Sulfate II DEA-DodecylbenzeneSulfonate x II 26545-53-9 DEA-Methyl Myristate Sulfonate II 64131-36-8 DEA-Cetyl Phosphate x II 61693-41-2 DEA-Ceteareth-2 Phosphate II DEA-Oleth-3 Phosphate II 58855-63-3 DEA-Oleth-5 Phosphate II 58855-63-3 DEA-Oleth-10 Phosphate x II 58855-63-3 DEA-Oleth-20 Phosphate II 58855-63-3 DEA-Hydrolyzed Lecithin II DEA-Di(2-Hydroxypalmityl) - no Phosphate[ Panel Book Page 6 NLM EU FDA ChemPortal conc Toxline- Misc ECE- IUCLID # uses NTIS Registry NTIS Merck EU SCCS SIDS IARC NTP EAFUS OTC HPVIS data Pubmed NLM TOC data set Methyl Diethanolamine x no x [105-59-9 ] Butyl Diethanolamine x X 102-79-4 N-Lauryl Diethanolamine x III [1541-67-9 ] Capramide DEA x III 136-26-5 Undecylenamide DEA x III 60239-68-1; 25377-64-4 Lauramide DEA x III x x 120-40-1 Myristamide DEA x III 7545-23-5 Lauramide/ Myristamide DEA III Palmitamide DEA x III 7545-24-6 Stearamide DEA x III 93-82-3 Behenamide DEA x III 70496-39-8 Lactamide DEA III Isostearamide DEA x X 52794-79-3 Oleamide DEA x III x x 5299-69-4; 93-83-4 Linoleamide DEA x III 56863-02-6 Almondamide DEA x III 124046-18-0 Apricotamide DEA x III 185123-36-8 Avocadamide DEA x III 124046-21-5 Babassuamide DEA x III 124046-24-8 Cocamide DEA x III x x x 61791-31-9 Cornamide DEA III Cornamide/ Cocamide DEA III Hydrogenated Tallowamide DEA x III 68440-32-4 Lanolinamide DEA x III [85408-88-4] Lecithinamide DEA III Minkamide DEA x III
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