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GREEN Dialkyl Hydroxysuccinates CIR EXPERT PANEL MEETING DECEMBER 12-13, 2011

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GREEN Dialkyl Hydroxysuccinates CIR EXPERT PANEL MEETING DECEMBER 12-13, 2011 November 19, 2011 MEMORANDUM To: CIR Expert Panel and Liaisons From: Lillian C. Becker, M.S. Scientific Analyst and Writer Subject: Draft Report for dialkyl hydroxysuccinates and hydroxysuccinic acids ingredients used in cosmetics The Cosmetic Ingredient Review (CIR) announced the Scientific Literature Review (SLR) for dialkyl hydroxysuccinates in August, 2011. Comments and unpublished data have been received from industry and incorporated into the report. While the group is correctly named dialkyl hydroxysuccinates, there are a lot of malate and tartrate (salts and esters) ingredients are included because those are the names the dictionary gives to those particular mono- and dihydroxysuccinates. Diisostearyl Malate was the widely used (576 uses) lead ingredient that made this safety assessment a priority. The Panel should review the Draft Report and decide whether any additional data are needed in order to reach a safety conclusion. If additional data re needed, the Panel should issue an insufficient data announcement and identify the data needs. If no additional data are required, then the Panel should develop a tentative conclusion, with a rationale to be included in the discussion, and should issue a Tentative Report. Distributed for Comment Only -- Do Not Draft or Cite CIR Panel Book Page 1 Distributed for Comment Only -- Do Not Draft or Cite History of Malates and Tartrates (dialkyl hydroxysuccinates and hydroxysuccinic acids) June, 2011 - Added to the 2011 Priority List. August, 2011 – SLR announced. December, 2011 – The Panel views the Draft Report. CIR Panel Book Page 2 Distributed for Comment Only -- Do Not Draft or Cite Malate and tartrate Data Profile for Decemeber, 2011. Writer ‐ Lillian Becker Repeated dose Sensitizatio ADME Acute toxicity Irritation toxicity n Penetration Dermal Log K Use Oral Dermal Inhale Oral Dermal Inhale Irritation Ocular Animal Dermal Irr. Human Dermal Irr Animal Sensitization Human Sensitization toxicity Repro/Devel Genotoxicity Carcinogenicity Phototoxicity ow Malic Acid X X X X X X X x X Sodium Malate X X Tartaric Acid X X X X X X x X Calcium Tartrate Disodium Tartrate Potassium X Sodium Tartrate Potassium Tartrate Diisostearyl X X Malate Dibutyloctyl X Malate Di-C12-13 Alkyl Malate Diethylhexyl X X x x Malate Diisoamyl Malate Dioctyldodecyl Malate Di-C12-13 Alkyl X Tartrate Di-C14-15 Alkyl Tartrate Dimyristyl X Tartrate CIR Panel Book Page 3 Distributed for Comment Only -- Do Not Draft or Cite Search Strategy for Dialkyl Hydroxysuccinates Search terms Pubmed SciFinder “Diisostearyl Malate” OR “67763-18-2” OR “Butanedioic 487984 hits, all diisostearyl acid, 2-hydroxy-, 1,4-bis(16-methylheptadecyl) ester” OR malate. “diisostearyl malate” “Butanedioic acid, hydroxy-, bis(16-methylheptadecyl) – 1 hit ester (9CI)” OR “81230-05-9” OR “Butanedioic acid, 2- hydroxy-, 1,4-diisooctadecyl ester” OR “Cosmol 222” OR “Haimalate DIS” OR “Salacos 222” OR “Schercemol DISM” OR “Schercemol TN” February 2011 “Dibutyloctyl Malate” OR “399551-19-0” OR “Butanedioic 227511 hits, none for a acid, 2-hydroxy-, 1,4-bis(2-butyloctyl) ester” OR quoted term “Butanedioic acid, hydroxy-, bis(2-butyloctyl) ester (9CI)” February 2011 ”Di-C12-13 Alkyl Malate” No hits February 2011 ”Diethylhexyl Malate” OR ”56235-92-8” OR “Butanedioic 4601 hits, none for the acid, 2-hydroxy-, 1,4-bis(2-ethylhexyl) ester” OR quoted phrase “Butanedioic acid, hydroxy-, bis(2-ethylhexyl) ester (9CI)” OR “Dermol DOM” OR “Di(2-ethylhexyl) malate” OR “Malic acid diester with 2-ethylhexyl alcohol” OR “NSC 68868” February 2011 “Diisoamyl Malate” OR “Butanedioic acid, 2-hydroxy-, No hits 1,4-bis(3-methylbutyl) ester” OR “Butanedioic acid, hydroxy-, bis(3-methylbutyl) ester (9CI)” OR ”Isopentyl alcohol, malate (2:1)” OR ”Malic acid, diisopentyl ester (6CI, 7CI, 8CI) » OR « AI 3-20830” OR “Diisoamyl malate” OR “Diisopentyl malate” OR “ENT 20830” February 2011 ”Dioctyldodecyl Malate” No hits February 2011 “Malic Acid” OR “6915-15-7” OR “Hydroxybutanedioic 2030 hits. “Malic Acid” – 2030 acid” OR “hydroxysuccinic acid” hits. With irritation, February 2011 sensitization, phototoxicity, photoallergenicity, immunotoxicity, pharmacokinetic, tumorigenicity, carcinogenicity, genotoxicity, reproductive or developmental toxicity – 30 hits, 3 possibly useful. DL-Form“617-48-1” No hits February 2011 D-(+)-Form “636-61-3” No hits February 2011 L-(-)-Form 7715 hits. Seach for full “97-67-6” OR “Butanedioic acid, 2-hydroxy-, (2S)-“ OR terms found: "(-)-L-Malic “Butanedioic acid, hydroxy-, (2S)- (9CI)” OR acid", "(S)-Malic acid", "L-(-)- “Butanedioic acid, hydroxy-, (S)-“ OR “Malic acid, l- Malic acid", "L-Malic acid", (3CI)” OR “Malic acid, L- (8CI)” OR “(-)-(S)-Malic acid” "S-(-)-Malic acid". 2 hits. OR “(-)-Hydroxysuccinic acid” OR “(-)-L-Malic acid” OR None useful. “(-)-Malic acid” OR “(2S)-2-Hydroxybutanedioic acid” OR “(2S)-2-Hydroxysuccinic acid” OR “(2S)-Malic acid” OR “(S)-Malic acid” OR “Apple acid” OR “L-(-)-Malic acid” OR “L-Apple acid” OR “L-Malic acid” OR “NSC 9232” OR “S-(-)-Malic acid” OR “S-2-Hydroxybutanedioic acid” OR “498-37-3” OR “124501-05-9” OR “84781-39-5” OR “6294-10-6” February 2011 “Butanedioic acid, 2-hydroxy-, (2R)-“ OR “Butanedioic 2070 hits. Search of full terms acid, hydroxy-, (2R)- (9CI)” OR “Butanedioic acid, "D-(+)-Malic acid" OR "D- hydroxy-, (R)-“ OR “Malic acid, D- (8CI)” OR “(+)-Malic Malic acid" – 17 hits. None acid” OR “(2R)-2-Hydroxybutanedioic acid” OR “(2R)- useful. Malic acid” OR “(R)-(+)-Malic acid” OR “(R)-Malic acid” CIR Panel Book Page 4 Distributed for Comment Only -- Do Not Draft or Cite OR “D-(+)-2-Hydroxysuccinic acid” OR “D-(+)-Malic acid” OR “D-Malic acid” OR “15856-21-0” February 2011 “6915-15-7” OR “Butanedioic acid, 2-hydroxy-“ OR No hits “Butanedioic acid, hydroxy- (9CI)” OR “Malic acid (8CI)” OR “(&plusminus;)-Malic acid” OR “α- Hydroxysuccinic acid” OR “2-Hydroxybutanedioic acid” OR “2-Hydroxyethane-1,2-dicarboxylic acid” OR “2- Hydroxysuccinic acid” OR “Deoxytetraric acid” OR “dl- Malic acid” OR “DL-Malic acid” OR “E 296” OR “FDA 2018” OR “Hydroxybutanedioic acid” OR “Hydroxysuccinic acid” OR “Musashi-no-Ringosan” OR “Nanoveson M” OR “NSC 25941” OR “Pomalus Acid” OR “R,S(&plusminus;)-Malic acid” OR “879715-44-3” OR “623158-98-5” OR “617-48-1” OR “41308-42-3” February 2011 “Sodium Malate” OR “58214-38-3” OR “Butanedioic acid, 126468 hits. Sodium malate 2-hydroxy-, sodium salt (1:1)” OR “Butanedioic acid, – 15 hits. None useful. hydroxy-, monosodium salt (9CI)” OR “Monosodium malate” OR “57467-17-1” February 2011 “Di-C12-13 Alkyl Tartrate” OR “94095-06-4” OR No hits “Butanedioic acid, 2,3-dihydroxy- (2R,3R)-, C12-14- branched and linear” OR “alkyl esters” OR “Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-14-branched and linear alkyl esters” February 2011 “Di-C14-15 Alkyl Tartrate” OR “55568-47-3” OR 1 hit. Not useful. “Butanedioic acid, 2-hydroxy-, 1,4-ditetradecyl ester” OR “Butanedioic acid, hydroxy-, ditetradecyl ester (9CI)” OR ”Ditetradecyl malate” “Dimyristyl Tartrate” OR “94237-18-0” OR “Butanedioic No hits acid, 2,3-dihydroxy- (2R,3R)-, 1,4-ditetradecyl ester” OR “Butanedioic acid, 2,3-dihydroxy- (2R,3R)-, ditetradecyl ester (9CI)” OR “Butanedioic acid, 2,3-dihydroxy- [R- (R*,R*)]-, ditetradecyl ester” OR “Dimyristyl tartrate” February 2011 “Dimyristyl Tartrate” OR “L-Tartaric Acid” OR “87-69-4” 1323 hits for “L-Tartaric Acid” OR “(2R,3R)-2,3-Dihydroxybutanedioic acid” OR “tartaric OR “tartaric acid” OR “d- acid” OR “natural tartaric acid” OR “d-tartaric acid” OR tartaric acid”. With irritation, “(+)-tartaric acid” OR “dextrotartaric acid” OR “L-2,3- sensitization, phototoxicity, dihydroxybutanedioic acid” OR “d-α,β-dihydroxysuccinic photoallergenicity, acid” OR “Weinsäure” OR “Weinsteinsäure” immunotoxicity, February 2011 pharmacokinetic, tumorigenicity, carcinogenicity, genotoxicity, reproductive or developmental – 13 hits, none useful. Malic Acid (2) (8966) > refine "toxicology" Substance Identifier "67763-18-2; 81230-05-9; 399551- (280) > refine "Book Clinical 19-0; Di C12-13 Alkyl Malate; 56235-92-8; 1587-19-5; Trial Commentary Dioctyldodecyl Malate; 97-67-6; 617-48-1; 636-61-3; Conference Dissertation 6915-15-7; 94095-06-4; Di-C12-13 Alkyl Tartrate; Di- Journal Letter Report C14-15 Alkyl Tartrate; 94237-18-0; 87-69-4; 133-37-9; Review" (115) > refine "NOT 147-71-7; 3164-34-9; 868-18-8; 6106-24-7; 304-59-6; plant" (84) > keep 17 6381-59-5; 921-53-9 references (17) > remove 0 April, 2011 references (17) Malic Acid - Substance Identifier "67763-18-2; 81230-05- (19) > get references 9; 399551-19-0; Di C12-13 Alkyl Malate; 56235-92-8; (21243) > refine 1587-19-5; Dioctyldodecyl Malate; 97-67-6; 617-48-1; "Toxicology" (666) > refine 636-61-3; 6915-15-7; 94095-06-4; Di-C12-13 Alkyl "NOT plant" (480) > remove Tartrate; Di-C14-15 Alkyl Tartrate; 94237-18-0; 87-69-4; 16 references (464) > refine 133-37-9; 147-71-7; 3164-34-9; 868-18-8; 6106-24-7; "Dermal" (7) 304-59-6; 6381-59-5; 921-53-9 " April, 2011 "67763-18-2; 81230-05-9; 399551-19-0; Di C12-13 Alkyl ( (21243) > refine Malate; 56235-92-8; 1587-19-5; Dioctyldodecyl Malate; "Toxicology" (666) > refine CIR Panel Book Page 5 Distributed for Comment Only -- Do Not Draft or Cite 97-67-6; 617-48-1; 636-61-3; 6915-15-7; 94095-06-4; Di- "NOT plant" (480) > remove C12-13 Alkyl Tartrate; Di-C14-15 Alkyl Tartrate; 94237- 16 references (464) > refine 18-0; 87-69-4; 133-37-9; 147-71-7; 3164-34-9; 868-18-8; "ld50" (8) 6106-24-7; 304-59-6; 6381-59-5; 921-53-9 " April,
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  • Metatartaric Acid (Tentative)

    0 out of 3 Residue Monograph prepared by the meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), 84th meeting 2017 Metatartaric Acid (Tentative) This monograph was also published in: Compendium of Food Additive Specifications. Joint FAO/WHO Expert Committee on Food Additives (JECFA), 84th meeting 2017. FAO JECFA Monographs 20 © FAO/WHO 2017 1 out of 3 METATARTARIC ACID (TENTATIVE) New tentative specifications prepared at the 84th JECFA (2017) and published in FAO JECFA Monographs 20 (2017). The 84th JECFA concluded that metatartaric acid (when used in winemaking) is included in the group ADI of 0–30 mg/kg bw for L(+)-tartaric acid and its sodium, potassium, potassium–sodium salts, expressed as L(+)- tartaric acid. Information required on: • Characterization of the product (optical rotation, content of free tartaric acid, degree of esterification and molecular weight distribution) • IR spectrum (in a suitable medium) • Analysis results including above parameters from a minimum of 5 batches of products currently available in commerce along with QC data. The Committee requests that this information be submitted by December 2018. SYNONYMS INS No. 353 DEFINITION Metatartaric acid is a polydisperse polymer of tartaric acid with a degree of esterification above 32%. It is manufactured by heating L- tartaric acid from natural sources at temperatures of 150-170º under atmospheric or under a reduced pressure. The product contains di- tartaric monoester and diester, other polyester acids of variable chain length, as well as non-esterified tartaric acid. Chemical name Metatartaric acid C.A.S. number 56959-20-7/ 39469-81-3 Chemical formula (C4H4O5)n Assay Not less than 105% as total tartaric acid DESCRIPTION Crystalline or powder form with an off-white colour.
  • Re‐Evaluation of L(+)‐Tartaric Acid (E 334), Sodium Tartrates

    Re‐Evaluation of L(+)‐Tartaric Acid (E 334), Sodium Tartrates

    SCIENTIFIC OPINION ADOPTED: 29 January 2020 doi: 10.2903/j.efsa.2020.6030 Re-evaluation of L(+)-tartaric acid (E 334), sodium tartrates (E 335), potassium tartrates (E 336), potassium sodium tartrate (E 337) and calcium tartrate (E 354) as food additives EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Furst,€ Rainer Gurtler,€ Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Romina Shah, Ine Waalkens-Berendsen, Detlef Wol€ fle, Polly Boon, Paul Tobback, Matthew Wright, Jaime Aguilera, Ana Maria Rincon, Alexandra Tard and Peter Moldeus Abstract The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on tartaric acid- tartrates (E 334-337, 354) when used as food additives. The Scientific Committee for Food (SCF) in 1990 established an acceptable daily intake (ADI) of 30 mg/kg body weight (bw) per day, for L(+)- tartaric acid and its potassium and sodium salts. The metabolism of L(+)-tartaric acid and its potassium sodium salt was shown to be species dependent, with a greater absorption in rats than in humans. No toxic effects, including nephrotoxicity, were observed in toxicological studies in which the L(+)-form was tested. There was no indication for a genotoxic potential of tartaric acid and its sodium and potassium salts. In a chronic study in rats, no indication for carcinogenicity of monosodium L(+)- tartrate was reported at the highest dose tested (3,100 mg/kg bw per day). The available studies for maternal or developmental toxicity did not report any relevant effects; no studies for reproductive toxicity were available; however, no effects on reproductive organs were observed in the chronic toxicity study.