Safety Assessment of Glycolactones as Used in Cosmetics

Abstract

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 glycolactone ingredients. Glucoheptonolactone and Gluconolactone are reported to function in cosmetics as skin-conditioning agents—miscellaneous, and Gluconolactone is also reported to function as a chelating agent. No functions are reported for the other 3 ingredients. The Panel considered the available data and concluded that Gluconolactone is safe in cosmetics in the present practices of use and concentration described in this safety assessment; however, the Panel concluded the available data are insufficient to make a determination that Galactonolactone, Glucarolactone, Glucoheptonolactone, and Ribonolactone are safe under the intended conditions of use in cosmetic formulations.

Keywords

Cosmetic Ingredient Review Expert Panel for Cosmetic Ingredient Safety Safety Cosmetics Galactonolactone Glucarolactone Glucoheptonolactone Gluconolactone Ribonolactone

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References

Personal Care Products Council . International Cosmetic Ingredient Dictionary. Washington, DC: Personal Care Products Council. Last Updated: 2020. https://incipedia.personalcarecouncil.org. Accessed April 9, 2020.

Ramachandran

Fontanille

Pandey

Larroche

. Gluconic acid: properties, applications and microbial production. Food Technol Biotechnol. 2006;44(2):185-195.

Fiume

Bergfeld

Belsito

, et al. Safety assessment of monosaccharides, disaccharides, and related ingredients as used in cosmetics. Int J Toxicol. 2019;38(suppl 1):5S-38S.

European Chemicals Agency (ECHA) . REACH Registration Dossier: D-Glucono-1,5-Lactone (CAS No. 90-80-2). Last Updated: 2020. https://echa.europa.eu/registration-dossier/-/registered-dossier/1952/7/2/2. Accessed April 9, 2020.

Organisation for Economic Cooperation and Development (OECD) . SIDS Initial Assessment Report for SIAM 18: Gluconic Acid and its Derivatives. 2004. https://hpvchemicals.oecd.org/UI/handler.axd?id=11548280-9a4f-4550-b0c5-192f53ac9279. Accessed April 9, 2020.

Human Metabolome Database (HMBD) . Metabocard for Gluconolactone (HMDB0000150). Last Updated: 2020. https://hmdb.ca/metabolites/HMDB0000150. Accessed August 13, 2020.

Human Metabolome Database (HMBD) . Metabocard for Galactonolactone (HMDB0002541). Last Updated: 2020. https://hmdb.ca/metabolites/HMDB0002541. Accessed April 10, 2020.

Human Metabolome Database (HMBD) . Metabocard for Ribonolactone (HMDB0001900). Last Updated: 2020. https://hmdb.ca/metabolites/HMDB0001900. Accessed August 13, 2020.

National Institute of Standards and Technology (NIST) . Chemistry WebBook SRD 69. D-Glucaro-3,6-Lactone. ■■■: U.S. Department of Commerce; 2020. Last Updated: 2020. https://webbook.nist.gov/cgi/inchi/InChI/1S/C6H8O7/c7-1-2(8)6(12)13-4(1)3(9)5(10)11/h1-4/7-9H/(H/10/11)/t1-/2-/3-/4/B/m1/s1. Accessed April 10, 2020.

10.

Agricultural Marketing Service U.S. Department of Agriculture (USDA) . Glucono Delta-Lactone: Processing. Last Updated: 2002. https://www.ams.usda.gov/sites/default/files/media/Glucono/Delta/Lactone/TR.pdf. Accessed August 13, 2020.

11.

EPA U . Washington, DC, USA: United States Environmental Protection Agency; 2020.

12.

PubChem. Glucoheptonolactone. https://pubchem.ncbi.nlm.nih.gov/compound/Glucoheptonolactone#section=Substances-by-Category. Last Updated: 2020. Accessed August 13, 2020.

13.

Mapson

LWBE

Breslow

. Biological synthesis of ascorbic acid: L-galactono-γ-lactone dehydrogenase. Biochem J. 1958;68(3):395-406.

14.

Williams

Kamath

Morris

Townsend

. D-ribonolactone and 2,3-isopropylidene (D-ribonolactone). Organic Synthesis. 2005;82:75-79.

15.

US Pharmacopeial Convention Inc . Food Chemicals Codex 11th Edition 2018-2019 (FCC-USP). 2021.

16.

US Food and Drug Administration (FDA) Center for Food Safety & Applied Nutrition (CFSAN) . Voluntary Cosmetic Registration Program - Frequency of Use of Cosmetic Ingredients. Obtained Under the Freedom of Information Act from CFSAN; Requested as “Frequency of Use Data”. College Park, MD: 2022. January 4, 2022; received January 11, 2022.

17.

Personal Care Products Council . Concentration of Use by FDA Product Category: Glycolactones. 2019. (Unpublished data submitted to Personal Care Products Council on July 24, 2019.).

18.

European Commission . Cosing Database; Following Cosmetic Regulation No. 1223/2009. Last Updated: 2020. https://ec.europa.eu/growth/tools-databases/cosing/. Accessed July 12, 2019.

19.

Dailey

. Monograph on glucono-delta-lactone, Report No. FDA/BF-78/138. Rockville, MD: Informatics Inc.; 1978.

20.

Jayamani

Ravikanth Reddy

Madhan

Shanmugam

. Disintegration of collagen fibrils by glucono-delta-lactone: an implied lead for disintegration of fibrosis. Int J Biol Macromol. 2018;107(Pt A):175-185.

21.

Kaewkod

Bovonsombut

Tragoolpua

. Efficacy of kombucha obtained from green, oolong, and black teas on inhibition of pathogenic bacteria, antioxidation, and toxicity on colorectal cancer cell line. Microorganisms. 2019;7(12):700.

22.

U.S. Food and Drug Administration (FDA) . FDA Label Search. Last Updated: 2020. https://labels.fda.gov/ingredientname.cfm. Accessed August 13, 2020.

23.

U.S. Food and Drug Administration (FDA) . Inactive Ingredient Search for Approved Drug Products. Last Updated: 2020. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?event=BasicSearch.page. Accessed August 26, 2020.

24.

Chenoweth

Civin

Salzman

Cohn

Gold

. Further studies on the behavior of glunic acid and ammonium gluconate in animals and man. J Lab Clin Med. 1941;1574-1582.

25.

van Logten

den Tonkelaar

Kroes

Berkvens

van Esch

. Long-term experiment with canned meat treated with sodium nitrite and glucono-delta-lactone in rats. Food Cosmet Toxicol. 1972;10(4):475-488.

26.

Food and Drug Research Labroratories Inc . Teratologic Evaluation of FDA 71-72 (Glucono Delta Lactone). East Orange, NJ: Food and Drug Research Laboratories Inc.; 1973.

27.

Litton Bionetics Inc . Mutagenic Evaluation of Compound FDA 71-72 glucono-delta-lactone. Kensington, MD: Litton Bionetics Inc.; 1974.

28.

Berardesca

Distante

Vignoli

Oresajo

Green

. Alpha hydroxyacids modulate stratum corneum barrier function. Br J Dermatol. 1997;137(6):934-938.

29.

Anonymous . Summaries of in Vitro Studies on Gluconolactone; 2021. (Unpublished data submitted by Personal Care Products Council on June 11, 2021.).

30.

Anonymous . Repeated Insult Patch Test (Product Contains 0.041625% Gluconolactone); 2016. (Unpublished data submitted by Personal Care Products Council on February 26, 2021).

31.

Anonymous . Repeated Insult Patch Test (Product Contains 1.4850% Gluconolactone); 2017. (Unpublished data submitted by Personal Care Products Council on February 22, 2021.).

32.

Consumer Product Testing Co . Repeated Insult Patch Test (Product Containing 15% Gluconolactone); 2005. (Unpublished data submitted by Personal Care Products Council on September 22, 2021.).

33.

Kantikosum

Chongpison

Chottawornsak

Asawanonda

. The efficacy of glycolic acid, salicylic acid, gluconolactone, and licochalcone A combined with 0.1% adapalene vs adapalene monotherapy in mild-to-moderate acne vulgaris: a double-blinded within-person comparative study. Clin Cosmet Invest Dermatol. 2019;12:151-161.

34.

Hunt

Barnetson

. A comparative study of gluconolactone versus benzoyl peroxide in the treatment of acne. Australas J Dermatol. 1992;33(3):131-134.