Hydrolyzed Collagen is a hydrolysate derived from animal byproducts. It is used in cosmetic products as a conditioner or moisturizer at concentrations less than 5 percent.
Hydrolyzed Collagen was practically nontoxic when administered orally or dermally in acute animal toxicity studies. This ingredient was minimally irritating to rabbit eyes when tested full-strength. Primary skin irritation tests in rabbits indicated that Hydrolyzed Collagen was nonirritating or minimally irritating when tested full-strength. Subchronic dermal studies on 2 cosmetic formulations containing 2 percent Hydrolyzed Collagen were negative for systemic toxicity. Hydrolyzed Collagen was nonsensitizing in guinea pigs.
In clinical studies, Hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity.
On the basis of the available animal and clinical data, it is concluded that Hydrolyzed Collagen is safe as a cosmetic ingredient in the present practices of use and concentration.
References
1.
1. Estrin, N.F., Crosley, P.A., and Haynes, C.R. (eds.). (1982). The CTFA Cosmetic Ingredient Dictionary, 3rd ed.Washington, DC: The Cosmetic, Toiletry and Fragrance Association.
2.
2. COSMETIC, TOILETRY AND FRAGRANCE ASSN. (CTFA). (September 16, 1982). Submission of unpublished data by CTFA: CTFA cosmetic ingredient chemical description (2–19–31).*
3.
3. Last, J.A., Baer, J., and Millson, C. (1976). Site of hydrolysis of collagen by hot trichloroacetic acid. Connect. Tissue Res.4(3), 149–53.
4.
4. Rogers, R. (August 1, 1978). Monograph on Collagen. NTIS No. PB-289599. Prepared by Informatics, Inc., Rockville, MD, for the Food and Drug Administration. Contract No. FDA 223–76–2001.
5.
5. Bore, M., and Arnaud, M. (1975). Control of protein hydrolysates and amino acids in cosmetic preparations. Labo-Pharma-Probl. Tech.23(240), 172–80.
6.
6. Borel, J.P., Desanti, M., Guillaume, G., and Barascut, J.L. (1968). A method for the detection of peptides separated by column chromatography: Application to the analysis of collagen hydrolysates. Bull. Soc. Chim. Biol. (Paris)50(11), 2165–77.
7.
7. Zarkadas, C.G. (January, 1975). A simple chromatographic method for the determination of the methylated basic amino acids in proteins. Can. J. Biochem.53(1), 96–101.
8.
8. Miller, E.J., and Piez, K.A. (August 1966). An accelerated single-column procedure for the automatic analysis of amino acids in collagen and elastin hydrolyzates. Anal. Biochem.16(2).
9.
9. Cunningham, L.W., Ford, J.D., and Segrest, J.P. (May 25, 1967). The isolation of identical hydroxylysyl glycosides from hydrolysates of soluble collagen and from human urine. J. Biol. Chem.242(10), 2570–1.
10.
10. Estrin, N.F., Haynes, C.R., and Whelan, J.M. (eds.). (1982). Cosmetic Ingredient Descriptions: Compendium of Cosmetic Ingredient Composition.Washington, DC: Cosmetic, Toiletry and Fragrance Association.
12. Frech, G., Allen, L.V., Stiles, M., and Levinson, R.S. (December 1979). Sodium acetate as a preservative in protein hydrolysate solutions. Am. J. Hosp. Pharm.36, 1672–75.
13.
13. Scafidi, A.A., and Neghme, B.M. (April 1980). Protein hydrolysates and condensates in creams and lotions. Cosmet. Toilet.95, 65–72.
14.
14. Cooperman, E.S. (1972). Protein hydrolysates as skin moisturizers. Am. Cosmetics Perfume87(3), 65–7.
15.
15. FOOD AND DRUG ADMINISTRATION (FDA). (December 1981). Product formulation data. Computer printout.
16.
16. Riso, R. (April 1974). Protein derivatives in cosmetics. Cosmetics Perfume89, 45–8.
17.
17. Constantinescu, M., Dobrescu, D., Voinescu, M.V., and Constantinescu, M. (July 23, 1980). Product from Collagen for Treating Gastritis and Gastric and Duodenal Ulcers. Rom. Patent No. 70153 (Institutul de Cercetari Pielarie si Incaltaminte).
18.
18. Easton, I.A., Glen, J.M., and Kieran, A.G. (March 25, 1981). Film Forming Composition and Its Uses. Eur. Pat. Appl. Patent No. 25640 (Devro, Inc.).
19.
19. Kim, C.D., Yang, S.J., and Lee, O.S. (October 1979). Effect of ginseng saponin on hair. Cosmet. Toilet.94, 49–50, 52, 56, 60, 62, 64.
20.
20. Karjala, S.A., Williamson, J.E., and Karler, A. (1966). Studies on the substantivity of collagen-derived polypeptides to human hair. J. Soc. Cosmet. Chem.
21.
21. Stern, E.S., and Johnsen, V.L. (August 1977). Studies on the molecular weight distribution of cosmetic protein hydrolysates. J. Soc. Cosmet. Chem.28, 447–55.
22.
22. Brooks, G.J. (July 1979). Use of protein in bath and shower products. Cosmet. Toilet.94, 82–4.
23.
23. Cooperman, E.S., and Johnsen, V.L. (July 1973). Penetration of protein hydrolysates into human hair strands. Cosmetics Perfume88, 19–22.
24.
24. Karjala, S.A., Bouthilet, R.J., and Williamson, J.E. (May 1966). Some factors affecting the substantivity of proteins to hair. The Toilet Goods Association, Proceedings of the Scientific Section.
25.
25. Schrader, K. (1981). Studies on water-retaining cosmetics on the skin. Parfuem. Kosmet.62(9), 265–72.
26.
26. Gumprecht, J.A. (June 8, 1977). Polypeptides for Cosmetic Use. Ger. Offen. Patent No. 2653560 (Redken Laboratories, Inc.).
27.
27. Cino, P.M., and Tewari, R.P. (September 1975). Proteolytic activity of Oidiodendron kalari. Can. J. Microbiol.21(9), 1362–8.
28.
28. Karpenko, G.F., and Kastrikina, T.F. (May-June 1977). Study of bone tissue insoluble collagen hydrolysis by Streptomyces griseus protease using the method of N-terminal analysis. Ukr. Biokhim. Zh.49(3), 80–4.
29.
29. Myshunin, I.F., Tsyperovych, O.S., and Kuznetsova, I.M. (March-April 1975). Hydrolysis of insoluble collagen of bull bones by Streptomyces griseus crystalline protease. Ukr. Biokhim. Zh.47(2), 226–32.
30.
30. Steffen, E.K., and Hentges, D.J. (August 1981). Hydrolytic enzymes of anaerobic bacteria isolated from human infections. J. Clin. Microbiol.14(2), 153–6.
31.
31. Oppenheim, F., and Franzblau, C. (1978). A modified procedure for the purification of clostridial collagenase. Prep. Biochem.8(5), 387–407.
32.
32. Coffey, J.W., Fiedler-Nagy, C., Georgiadis, A.G., and Salvador, R.A. (September 10, 1976). Digestion of native collagen, denaturated collagen, and collagen fragments by extracts of rat liver lysosomes. J. Biol. Chem.251(17), 5280–2.
33.
33. Werb, Z., and Reynolds, J.J. (December 1975). Purification and properties of a specific collagenase from rabbit synovial fibroblasts. Biochem. J.151(3), 645–53.
34.
34. Evans, P., and Etherington, D.J. (February 1, 1978). Characterization of cathepsin B and collagenolytic cathepsin from human placenta. Eur. J. Biochem.83(1), 87–97.
35.
35. Carrick, K., Jr., and Berk, R.S. (June 24, 1975). Purification and partial characterization of a collagenolytic enzyme from Pseudomonas aeruginosa. Biochim. Biophys. Acta391(2), 422–34.
36.
36. Robert, A.M., Godeau, G., Moati, F., and Miskulin, M. (1977). Action of anthocyanosides of Vaccinium myrtillis on the permeability of the blood-brain barrier. J. Med.8(5), 321–32.
37.
37. Dreisbach, J.H., and Merkel, J.R. (August 1978). Induction of collagenase production in Vibrio B-30. J. Bacteriol.135(2), 521–7.
38.
38. Sharaev, P.N., Bogdanov, N.G., and Iamaldinov, R.N. (June 1976). Collagen metabolism in the skin with different vitamin K regimens. Biull. Eksp. Biol. Med. (Bulletin of Experimental Biology and Medicine).
39.
39. Dziewiatkowski, D.D., Hascall, V.C., and Riolo, R.L. (October 1972). Epimerization of trans-4-hydroxy-L-proline to cis-4-hydroxy-D-proline during acid hydrolysis of collagen. Anal. Biochem.49(2), 550–8.
40.
40. Nosova, I.M., Pisarzhevskii, S.A., Aboiants, R.K., and Karelin, A.A. (August 1981). Mechanism of action of collagen on processes of regeneration. Bull. Exp. Biol. Med. (Russian)92(8), 79–81.
41.
41. CTFA. (August 19, 1975). Submission of unpublished data by CTFA. Primary skin irritation, sensitization, and acute oral toxicity tests (2–19–3).*
42.
42. CTFA. (April 29, 1974). Submission of unpublished data by CTFA. Acute oral toxicity test (2–19–25).*
43.
43. CTFA. (December 6, 1977). Submission of unpublished data by CTFA. Acute oral toxicity test (2–19–11).*
44.
44. CTFA. (December 6, 1977). Submission of unpublished data by CTFA. Acute oral toxicity test (2–19–12).*
45.
45. CTFA. (March 3, 1978). Submission of unpublished data by CTFA. Guinea pig sensitization test (2–19–16).*
46.
46. FOOD AND DRUG RESEARCH LABORATORIES. (FDRL). (May 1, 1978). Acute oral toxicity test (2–19–8).*
47.
47. CTFA. (September 4, 1973). Submission of unpublished data by CTFA. Acute eye irritation test (2–19–26).*
48.
48. CTFA. (April 27, 1972). Submission of unpublished data by CTFA. Acute eye irritation test (2–19–27).*
49.
49. CTFA. (December 13, 1978). Submission of unpublished data by CTFA. Acute eye irritation test (2–19–15).*
50.
50. FDRL. (April 24, 1978). Acute eye irritation test (2–19–6).*
51.
51. CTFA. (September 4, 1973). Submission of unpublished data by CTFA. Primary skin irritation test (2–19–28).*
52.
52. CTFA. (April 28, 1972). Submission of unpublished data by CTFA. Primary skin irritation test (2–19–29).*
53.
53. Nilzen, A. (1965). Two Types of Soap of Medical interest. Allergies Laboratories, Karolinska sjukhuset, Stockholm.*
54.
54. TOXICOLOGY AND PATHOLOGY SERVICES (TPS). (February 9, 1978). Acute dermal toxicity test (2–19–9).*
55.
55. CTFA. (December 3, 1977). Submission of unpublished data by CTFA. Primary skin irritation test (2–19–14).*
56.
56. CTFA. (March 5, 1978). Submission of unpublished data by CTFA. Primary skin irritation test (2–19–17).*
58. CTFA. (January 25, 1979). Submission of unpublished data by CTFA. Subchronic dermal toxicity test (2–19–22).*
59.
59. TPS. (February 15, 1978). Subchronic dermal toxicity test (2–19–10).*
60.
60. Buehler, E.V., and Griffith, F. (1975). In: Maibach (ed.). Animal Models in Dermatology.Edinburgh: Churchill Livingston, pp. 55–66.
61.
61. CTFA. (January 6, 1978). Submission of unpublished data by CTFA. Guinea pig phototoxicity test (2–19–13).*
62.
62. CTFA. (April 3, 1972). Submission of unpublished data by CTFA. Clinical skin irritation test (2–19–30).*
63.
63. CTFA. (July 9, 1971). Submission of data in support of safety of potassium-coco-hydrolyzed animal protein and related compounds. Human patch test. Tokyo Medical and Dental University Dermatology Dept., Toshikatsu Irimajiri.*
69. CTFA. (September 17, 1979). Submission of unpublished data by CTFA. Clinical controlled use test (2–19–19).*
70.
70. NORTH AMERICAN CONTACT DERMATITIS GROUP (NACDG). (1982). Prospective study of cosmetic reactions: 1977–80. J. Am. Acad. Dermatol.6, 909–17.
71.
71. CTFA. (September 17, 1979). Submission of unpublished data by CTFA. Clinical phototoxicity and photo-sensitization tests (2–19–20).*
72.
72. Domsch, A., Pospischil, H., Schuster, G., and Tronnier, H. (1980). Cosmetic dermatological effects of protein hydrolyzates. Parfuem. Kosmet.61(9), 325–30. *Available upon request: Administrator, Cosmetic Ingredient Review, Suite 810, 1110 Vermont Avenue, N.W., Washington, DC 20005.
