Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products

Food and Chemical Toxicology

Volumn 47, Issue 6, 2009, Pages 1246-1254

  Re, T A ^a   Mooney, D ^a   Antignac, E ^a   Dufour, E ^a   Bark, I ^a   Srinivasan, V ^a   Nohynek, G ^a  

^a L ORÉAL RECHERCHE   (France)

Author keywords

Calendula; Cosmetics; Safety evaluation; TTC

Indexed keywords

CALENDULA EXTRACT; COSMETIC;

ANIMAL EXPERIMENT; ARTICLE; CALCULATION; EXPOSURE; FEMALE; FLOWER; MALE; MOLECULAR WEIGHT; NONHUMAN; PETAL; RAT; RISK ASSESSMENT; SAFETY; SKIN IRRITATION; SKIN PENETRATION;

CALENDULA; CHEMISTRY, PHARMACEUTICAL; COSMETICS; FLOWERS; HUMANS; MOLECULAR WEIGHT; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PLANT EXTRACTS; RISK ASSESSMENT; SKIN ABSORPTION;

CALENDULA; CALENDULA OFFICINALIS;

EID: 67349118727     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2009.02.016     Document Type: Article

References (43)

1. Alonso, J, 2004. In: Tratado de Fitofarmacos y Nutraceuticos. Corpus Barcelona, pp. 251-255.
2. Anonymous. IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans: some food additives. Feed Additives and Naturally Occurring Substances 31 (1983) 171-178
3. Anonymous, 2008. Tentative amended safety assessment of Calendula officinalis extract, Calendula officinalis flower, Calendula officinalis flower extract, Calendula officinalis flower oil and Calendula officinalis seed oil. Cosmetic Ingredient Review. Washington DC.
4. Blumenthal M., Goldberg A., and Brinckmann J. Calendula flower. Herbal Medicine Expanded Commission E Monographs (2000), American Botanical Council, Austin 4-45
5. Bonina F., Lanza M., Montenegro L., Puglisi C., Tomaino A., Trombetta D., Castelli F., and Saija A. Flavinoids as potential protective agents against photo-oxidative skin damage. International Journal of Pharmaceutics 145 (1996) 87-94
6. Constable A., Jonas D., Cockburn A., Davi A., Edwards G., Hepburn P., Herouet-Guicheney C., Knowles M., Moseley B., Oberdörfer R., and Samuels F. History of safe use as applied to the safety assessment of novel foods and foods derived from genetically modified organisms. Food and Chemical Toxicology 45 12 (2007) 2513-2525
7. Cramer G.M., Ford R.A., and Hall R.L. Estimation of toxic hazard - decision tree approach. Food and Cosmetics Toxicology 16 3 (1978) 255-276
8. Dedio I. Value of Calendula officinalis L. inflorescences as a tannin crude drug. Herba Pol. 29 3-4 (1983) 211-216
9. Duke, J., 1996. Dr. Duke's Phytochemical and Ethnobotanical Databases. .
10. EFSA, 2006. European Food Safety Authority. Scientific Committee on Food, Scientific Panel on Dietetic Products, Nutrition And Allergies. Tolerable Upper Intake Levels for Vitamins and Minerals. .
11. EMEA, 2008a. European Medicines Agency, Committee on Herbal Medicinal Products (HMPC). Assessment Report for the Development of Community Monographs and for Inclusion of Herbal Substance(s), Perparation(s) or Combinations Thereof in the Community List. EMEA/HMPC/179282/2007, London 6 March 2008. .
12. EMEA, 2008b. European Medicines Agency, Committee on Herbal Medicinal Products (HMPC). Community Herbal Monograph on Calendula Officinalis Ll, Flos. EMEA/HMPC/179281/2007Coor, London, 2 May 2008. .
13. Felter SP., Vassallo JD., Carlton B.D., and Daston G.P. A safety assessment of coumarin taking into account species-specificity of toxicokinetics. Food and Chemical Toxicology 44 (2006) 462-475
14. Food and Drug Administration, 2007. Food and Drug Administration Department of Health and Human Services. Food for Human Consumption; Substances Generally Recognized as Safe 21 CFR Part 182.10.
15. Hagerman, Ann E., 2002. Tannin Chemistry. pdf file. .
16. Harikumar K.B., Nimita C.V., Preethi K.C., Kuttan R., Shankaranarayana M.L., and Deshpande J. Toxicity profile of lutein and lutein ester isolated from marigold flowers (Tagetes erecta). International Journal of Toxicology 27 (2008) 1-9
17. Hall R.L., and Oser B.L. Recent progress in the consideration of flavoring ingredients under the food additives amendment 3 GRAS substances. Food Technology 19 2 (1965) 151-197 (Part 2)
18. Harwood M., Danielewska-Niekiel B., Borzelleca J.F., Flamm G.W., Williams G.M., and Lines T.C. A critical review of the data related to the safety of quercertin and lack of evidence of in vivo toxicity, including lack of genotoxic/carcinogenic properties. Food and Chemical Toxicology 45 (2007) 2179-2205
19. Ideaconsult LTD, 2008. Toxtree (Estimation of Toxic Hazard - A Decision Tree Approach v1.50.
20. JECFA, 1974. NMRS 54/TRS 557-JECFA 18. Evaluation of certain food additives (Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives). In: FAO Nutrition Meetings Series, No. 54, 1974; WHO Technical Report Series, No. 557, 1974, and Corrigendum.
21. Jellin, J.M., Gregory, P.J., Batz, F., Hitchens, K., et al. 2003. Pharmacist's Letter/Prescriber's Letter Natural Medicines Comprehensive Database, 5th ed. Stockton, CA, pp. 265-66.
22. Korakhashvili, A., Kacharava, T., Kiknavelidze, N., 2007. Georgian Medical News No. 7-8 (148-149) 70-73.
23. Kishimoto S., Maoka T., Sumitomo K., and Ohmiya A. Analysis of carotenoid composition in petals of calendula (Calendula offinialis L.). Bioscience Biotechnology and Biochemistry 69 11 (2005) 2122-2128
24. Kroes R., Kleiner J., and Renwick A. The threshold of toxicological concern concept in risk assessment. Toxicological Sciences 86 (2005) 226-230
25. Kroes R., Renwick A.G., Feron V., Galli C.L., Gibney M., Greim H., Guy R.H., Lhuguenot J.C., and van de Sandt J.J. Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients. Food and Chemical Toxicology 45 12 (2007) 2533-2562
26. Lueng A.Y., and Foster S. Calendula. Encyclopedia of Common Natural Ingredients used in Food Drugs and Cosmetics (1996), John Wiley & Sons, New York 113-114
27. Munro I.C., Ford R.A., Kennepohl E., and Sprenger J.G. Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology 34 9 (1996) 829-867
28. Munro I.C., Renwick A.G., and Danielewska-Nikiel B. The threshold of toxicological concern (TTC) in risk assessment. Toxicology Letters 180 (2008) 151-156
29. Müller L., Mauthe R.J., Riley C.M., Andino M.M., Antonis D.D., Beels C., DeGeorge J., De Knaep A.G., Ellison D., Fagerland J.A., Frank R., Fritschel B., Galloway S., Harpur E., Humfrey C.D., Jacks A.S., Jagota N., Mackinnon J., Mohan G., Ness D.K., O'Donovan M.R., Smith M.D., Vudathala G., and Yotti L. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regulation of Toxicology and Pharmacology 44 3 (2006) 198-211
30. NTP Working Group, 1992. Toxicology and carcinogenesis studies of quercetin in F344/N rats (feed studies). National Toxicology Program Technical Report Series, 409.
31. Onodera H., Kitaura K., Mitsumori K., Yoshida J., Yasuhara K., Shimo T., Tahahashi M., and Hayashi Y. Study on the carcinogenicity of tannic acid in F344 rats. Food and Chemical Toxicology 32 12 (1994) 1101-1106
32. Renwick A.G. Toxicology databases and the concept of thresholds of toxicological concern as used by the JECFA for the safety evaluation of flavouring agents. Toxicology Letters 149 (2004) 223-234
33. SCCP, 2006. European Commission. Health and Consumer Protection, Directorate General. Scientific Committee on Consumer Products. The SCCP's Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 6th Revision. In: Adopted by the SCCP During the 10th Plenary Meeting of 19 December, 2006.
34. Silva E.J.R., Aquiar F.J.S., Goncalves E.S., Sousa I.M.V., Dimech G.S., Fraga M.C.C.A., Coehlo M.C.O.C., and Wanderly A.G. Evaluation of subchronic treatment with the hydroalcoholic extract of Calendula officinalis L. on biochemical and hematological parameters in female Wistar rats. Brazilian Journal of Pharmacognosy 15 2 (2005) 88-93
35. Silva E.J.R., Concalves E.S., Aquiar F., Evencio L.B., Lyra M.M.A., Coelho M.C.O.C., Fraga M.C.C.A., and Wanderly A.G. Toxicological studies on hydroalcohol extract of Calendula officinalis L. Phytotherapy Research 21 (2007) 332-336
36. Smith R.L., Adams T.B., Cohen S.M., Doull J., Feron V.J., Goodman J.I., Hall R.L., Marnett L.J., Portoghese P.S., Waddell W.J., and Wagner B.M. Safety evaluation of natural flavour complexes. Toxicology Letter 149 1-3 (2004) 197-207
37. Smith R.L., Cohen S.M., Doull J., Feron V.J., Goodman J.I., Marnett L.J., Portoghese P.S., Waddell W.J., Wagner B.M., Hall R.L., Higley N.A., Lucas-Gavin C., and Adams T.B. A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: essential oils. Food and Chemical Toxicology 43 3 (2005) 345-363
38. Sudha M., Gnanamani A., Deepa F., Sudha M., Madhavacharyulu E., Deivanai K., and Sadulla S. In vivo studies on evaluation of potential toxicity of unspent tannins using albino rats (Rattus norvegicus). Food and Chemical Toxicology 46 (2008) 2288-2295
39. Tetko I.V., Gasteiger J., Todeschini R., Mauri A., Livingstone D., Ertl P., Palyulin V.A., Radchenko E.V., Zefirov N.S., Makarenko A.S., Tanchuk V.Y., and Prokopenko V.V. Virtual computational chemistry laboratory - design and description. Journal of Computer Aided Molecular Design 19 (2005) 453-463
40. US National Library of Medicine, 2008. TOXNET Toxicology Network. ChemIDplus. .
41. UNITIS, 2006. The European Organization of Cosmetic Ingredients Industries and Services. Natural Product Consulting. 2006 UNITIS - Calendula officinalis. Report June 12, 2006. Unpublished data provide by the CTFA (available from the Cosmetic Ingredient Review, Washington, DC.
42. Valdes LH., and Garcia RP. Calendula officinalis. Review of Cubana Plant Medicine 1 3 (1999) 188-194
43. VCCLAB, 2005. Virtual Computational Chemistry Laboratory. .