Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
권호 표지
DOI QR코드

DOI QR Code

Safety assessment of cocamidopropyl betaine, a cosmetic ingredient

  • Received : 2023.12.26
  • Accepted : 2024.04.24
  • Published : 2024.07.15
⟨ Previous Next ⟩

Abstract

Cocamidopropyl betaine (CAPB) is a surfactant derived from coconut oil that is widely used in cosmetics and personal products for several purposes, such as a surfactant, foam booster, mildness, and viscosity control. Cocamidopropyl betaine is used at concentrations up to 30% in cosmetics. The acute toxicity, skin irritation, eye irritation, skin sensitization, repeated dose toxicity, genotoxicity, carcinogenicity, and phototoxicity of cocamidopropyl betaine were evaluated. Cocamidopropyl betaine was observed to induce mild skin irritation, eye irritation and skin sensitization. The NOAEL of cocamidopropyl betaine was determined to be 250 mg/kg/day based on the results of a 92-day repeated-dose oral toxicity study in rats. The systemic exposure dose of cocamidopropyl betaine was estimated to range from 0.00120 to 0.93195 mg/kg/day when used in cosmetic products. The margin of safety of cocamidopropyl betaine was calculated to be greater than 100 when used at a maximum concentration of 6% in leave-on products and 30% in rinse-of products, suggesting that its use in cosmetic products is safe under current usage conditions.

Keywords

Acknowledgement

Figure 1 was created with BioRender.com.

References

  1. PubChem. https://pubchem.ncbi.nlm.nih.gov 
  2. CTFA (1984) Cosmetic ingredient chemical description for cocamidopropyl betalne (Unpublished data, 3) 
  3. Food and Drug Administration (2010) Frequency of use of cosmetic ingredients 
  4. CTFA. Leberco Laboratories (1976) Acute oral toxicity in mice of Schercotaine CAB. L#114-85 (Unpublished data, 2) 
  5. CTFA. International Bio-Research, Inc (1977) Acute oral toxicity of Tego-Betain L 7 in rats (Unpublished data, 17) 
  6. CTFA. Bio-Toxicology Laboratories, Inc (1977) Acute oral LD50 toxicity study for cocamidopropyl betaine 30% solution (Unpublished data, 8) 
  7. CTFA. Food and Drug Research Laboratories, Inc (1982) Acute oral LD50 assay in rats of Velvetex BK-35 (full strength) (Unpublished data, 12) 
  8. American Chemistry Council (2009) Fatty nitrogen derived amides high production volume (HPV) chemicals challenge. https://www.epa.gov/chemrtk/pubs/summaries/fantdrad/c13319.pdf 
  9. CTFA. Hill Top Research, Inc (1980) Report of a human skin test of cumulativeirritation for 2 soaps containing 7.5% Cocamidopropyl Betaine (Unpublished data, 19) 
  10. Elder RL (1991) Final report on the safety assessment of cocamidopropyl betaine. J Am Coll Toxicol 10:33-52. https://doi.org/10.3109/10915819109078621 
  11. Militello M, Hu S, Laughter M, Dunnick CA (2020) American Contact Dermatitis Society Allergens of the Year 2000 to 2020. Dermatol Clin 38:309-320. https://doi.org/10.1016/j.det.2020.02.011 
  12. CTFA. Reprotox -Huntingdon Research Centre (1980) Screening test for delayed contact hypersensitivity with Tego-Betaln L7 (Handelskonzentration) in the albino guinea pig (Unpublished data, 9) 
  13. CTFA. Springborn Institute of Bioresearch, Inc (1982) Delayed contact hypersensitivity in guinea pigs (Unpublished data, 16) 
  14. Rantuccio F, Coviello C, Sinisi D, Scardigno A, Conte A (1983) Experimental sensitization of guinea pigs by drugs. Comparison of the maximization test with the wholly intradermal test. Contact Dermatitis 9:479-483. https://doi.org/10.1111/j.1600-0536.1983.tb04467.x 
  15. CTFA. Cosmetic, Toiletry and Fragrance Association (1980) Repeat insult patch test (human skin sensitization) (Unpublished data, 33) 
  16. CTFA. Hill Top Research, Inc (1982) Repeat insult patch test (human skin sensitization). Report no. 82-0690-72(A) (Unpublished data, 68) 
  17. CTFA. Hill Top Research, Inc (1984) Repeat insult patch test (human skin sensitization) Report no. 82-1082-72(c) (Unpublished data, 46) 
  18. CTFA. Hill Top Research, Inc (1988) Repeated insult patch test and evaluation of photoallergy for CTFA. Report no. 86-1402-70 (Unpublished data, 47) 
  19. Clinical Research Laboratories, Inc. The Personal Care Products Council (2009) Repeated insult patch test of a cleansing cloth containing 6% active CAPB. Study Number CRL125301 Phase I. 2002 (Unpublished data, February 13) 
  20. Clinical Research Laboratories, Inc. The Personal Care Products Council (2009) Repeated insult patch test of a cleansing cloth containing 6% active CAPB. Study Number CRL125301 Phase II. 2002 (Unpublished data, February 13) 
  21. The Personal Care Products Council (2009) An evaluation of the contact-sensitization potential of a topical coded product (facial cleanser containing 3.6% active CAPB) in human skin by means of the maximization assay. 2007 (Unpublished data, 11). KGL, Inc 
  22. de Groot AC, van der Walle HB, Weyland JW (1995) Contact allergy to cocamidopropyl betaine. Contact Dermatitis 33:419-422. https://doi.org/10.1111/j.1600-0536.1995.tb02078.x 
  23. Armstrong D, Smith H, Ross J, White I (1999) Sensitization to cocamidopropylbetaine: an 8-year review. Contact Dermatitis 40:335-336. https://doi.org/10.1111/j.1600-0536.1999.tb06094.x 
  24. Shafer KK, Jaimes JP, Hordinsky MK, Zielke GR, Warshaw EM (2006) Allergenicity and cross-reactivity of coconut oil derivatives: a double-blind randomized controlled pilot study. Dermatitis 17:71-76. https://doi.org/10.2310/6620.2006.05043 
  25. Personal Care Products Council (2009) Summaries of two 1987 guinea pig maximization studies on amidoamine (Unpublished data, 4) 
  26. Fowler JF Jr (1993) Cocamidopropyl betaine: the significance of positive patch test results in twelve patients. Cutis 52:281-284 
  27. DE B. Hazelton Laboratories America, Inc (1989) Subchronic oral toxicity study in rats (Unpublished data, 319) 
  28. CTFA. EG&G Mason Research Institute (1981) Cocamidopropyl Betaine (31.0% active) in a Salmonella/mammalian microsome mutagenesis assay (Ames test). Report no. 003-439-662-1 (Unpublished data, 27) 
  29. Jagannath DR. CTFA, Hazelton Laboratories America, Inc (1988) Mutagenicity test on Cocamidopropyl Betaine in the Ames Salmonella/microsomereversemutation assay (Unpublished data, 22) 
  30. CTFA. Cosmetic, Toiletry and Fragrance Association (1982) Test for chemical induction of mutation in mammalian cells in culture-the L5178Y TK +/- mouse lymphoma assay. Report no. T1755.701 (Unpublished data, 24) 
  31. Jacobs MM, Burnett CM, Penicnak AJ, Herrera JA, Morris WE, Shubik P, Apaja M, Granroth G (1984) Evaluation of the toxicity and carcinogenicity of hair dyes in Swiss mice. Drug Chem Toxicol 7:573-586. https://doi.org/10.3109/01480548409042820 
  32. Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Andersen FA (2012) Final report of the Cosmetic Ingredient Review Expert Panel on the safety assessment of cocamidopropyl betaine (CAPB). Int J Toxicol 31:77S-111S. https://doi.org/10.1177/1091581812447202 
  33. SCCS members, Other experts (2021) The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30-31 March 2021, SCCS/1628/21. Regul Toxicol Pharmacol 127:105052. https://doi.org/10.1016/j.yrtph.2021.105052 
  34. Ficheux AS, Bernard A, Chevillotte G, Dornic N, Roudot AC (2016) Probabilistic assessment of exposure to hair cosmetic products by the French population. Food Chem Toxicol 92:205-216. https://doi.org/10.1016/j.fct.2016.04.009 
  35. Bernard A, Dornic N, Roudot A, Ficheux A (2018) Probabilistic exposure assessment to face and oral care cosmetic products by the French population. Food Chem Toxicol 111:511-524. https://doi.org/10.1016/j.fct.2017.11.056 
  36. Administration NMP (2021) Catalogue of used cosmetic raw materials 
  37. EU CosIng. https://ec.europa.eu/growth/tools-databases/cosing 
  38. Cosmair, Inc (1989) Product specifications (Unpublished data, 11) 
  39. Leberco Laboratories (1965) Eye Irritation study on Tegobetain L-7 (30% active) (Unpublished data, 1965) 
  40. CTFA. Leberco Laboratories (1974) Eye irritation study on 30% solution of cocamidopropyl betaine (Unpublished data, 5) 
  41. CTFA. Leberco Laboratories (1975) Eye irritation study on 6% solution of cocamidopropyl betaine (Unpublished data, 5) 
  42. CTFA. International Bio-Research, Inc (1977) Draize animal mucous membrane irritation test of Tego-Betain L 7 (Unpublished data, 9) 
  43. CTFA. Consumer Product Testing (1978) Primary dermal irritation (rabbit) and ocular irritation (rabbit) study on experimental product R33.33-41A (CTFA, Unpublished data, 5) 
  44. CTFA. Food and Drug Research Laboratories, Inc (1982) Primary eye irritation study in albino rabbits (Wolcott design) (Unpublished data, 14) 
  45. CTFA. Food and Drug Research Laboratories, Inc (1982) Primary eye irritation study in albino rabbits (Wolcott design) (Unpublished data, 12) 
  46. CTFA. Hazelton Laboratories (1984) Rewoteric AM-B 13 (V 1675) (5 prozentige Losung) Schleimhautvertraglichkeitsprufung Am Kaninchenauge [Rewoteric AM-B 13 (V 1675) (5 percent solution) mucous membrane compatibility test in the rabbit eye] (Unpublished data, 15) 
  47. CTFA. Hazelton Laboratories (1984) Rewoteric AM-B 13 (V 1675) (10 prozentige Losung) Schleimhautvertraglichkeitsprufung Am Kaninchenauge [Rewoteric AM-B 13 (V 1675) (10 percent solution) mucous membrane compatibility test in the rabbit eye] (Unpublished data, 15) 
  48. Frost P, Horwitz SN (1982) Principles of cosmetics for the dermatologist, 1st edn. Mosby (January 1, 1982) 
  49. Journal Officiel de la Republique Francaise (1971) Official methods of analysis of cosmetics and beauty products. Annex II. Official method for the determination of eye irritation (Translation) 
  50. CTFA. Seppic (1985) Summary of toxicological data (skin and eye irritation) on Amonyl 380 BA, Cocamidopropyl Betaine (Unpublished data, 4) 
  51. CTFA. Stillmeadow, Inc (1980) Rabbit eye irritation study on soap CBF-01-69 containing 7.5% Cocamidopropyl Betaine. Project 1820-80 (Unpublished data, 14) 
  52. CTFA. Stillmeadow, Inc (1980) Rabbit eye irritation study on soap CBF-01-69 containing 7.5% Cocamidopropyl Betaine. Project 1821-80 (Unpublished data, 14) 
  53. CTFA. Cosmetic, Toiletry and Fragrance Association (1983) Eye irritation study on 6.5% solution of Cocamidopropyl Betaine (Unpublished data, 6) 
  54. Leberco Laboratories (1967) Skin irritation study on Tegobetaine C (Unpublished data) 
  55. CTFA. Bio-Toxicology Laboratories, Inc (1974) Primary irrritation study for cocamidopropyl betaine 30% solution (Unpublished data, 10) 
  56. CTFA. Leberco Laboratories (1975) Skin irritation study on Schercotaine CAB 25%. L#119-129 (Unpublished data, 2) 
  57. CTFA. Reprotox - Huntingdon Research Centre (1980) Irritant effects of Tego-Betain L7 (10% Aktivsubstanz) to rabbit skin (Unpublished data, 8) 
  58. CTFA. Food and Drug Research Laboratories, Inc (1982) Primary skin irritation study in albino rabbits on Velvetex BK-35 (Unpublished data 12) 
  59. CTFA. Tox Monitor Laboratories, Inc (1983) Primary skin irritation study on Mackam 35 (15% solution Cocamidopropyl Betaine). Report no. TM83-265 (Unpublished data, 4) 
  60. Vilaplana J, Grimalt F, Romaguera C (1990) Contact dermatitis from cocamidopropyl betaine. Contact Dermatitis 23:274-274. https://doi.org/10.1111/j.1600-0536.1990.tb05097.x