Safety evaluation of superabsorbent baby diapers

Regulatory Toxicology and Pharmacology

Volumn 53, Issue 2, 2009, Pages 81-89

  Kosemund, Kirstin ^a   Schlatter, Harald ^a   Ochsenhirt, Jennifer L ^a   Krause, Edburga L ^a   Marsman, Daniel S ^a   Erasala, Geetha N ^a  

^a PROCTER AND GAMBLE COMPANY   (United States)

Author keywords

Contact dermatitis; Diaper rash; Diaper safety; Infant diapers; Risk assessment

Indexed keywords

COLORING AGENT; POLYMER;

ARTICLE; DATA ANALYSIS; DIAPER; EVALUATION; MATERIALS TESTING; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; SAFETY; SUPERABSORBENT BABY DIAPER;

CAREGIVERS; COLORING AGENTS; CONSUMER PRODUCT SAFETY; CONTROLLED CLINICAL TRIALS AS TOPIC; DERMATITIS, CONTACT; DIAPERS, INFANT; HUMANS; INFANT; POLYMERS; RISK ASSESSMENT; TOXICITY TESTS;

EID: 59849119089     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2008.10.005     Document Type: Article

References (73)

1. Adam R. Skin care of the diaper area. Pediatr. Dermatol. 25 4 (2008) 1-7
2. Andersen P.H., Bucher A.P., Saeed I., Lee P.C., Davis J.A., and Maibach H.I. Faecal enzymes: in vivo human skin irritation. Contact Dermatitis 30 3 (1994) 152-158
3. Blackburn K., Stickney J.A., Carlson-Lynch H.L., McGinnis P.M., Chappell L., and Felter S.P. Application of the threshold of toxicological concern (TTC) approach to ingredients of consumer products. Regul. Toxicol. Pharmacol. 43 3 (2005) 249-259
4. Bowman J.P., Berger R.S., Mills O.H., Kligman A.M., and Stoudemayer T. The 21-day human cumulative irritation test can be reduced to 14 days without loss of sensitivity. J. Cosmet. Sci. 54 5 (2003) 443-449
5. Campbell R.L. Clinical tests with improved disposable diapers. Pediatrician 14 Suppl. 1 (1987) 34-38
6. Campbell R.L., Seymour J.L., Stone L.C., and Milligan M.C. Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition. J. Am. Acad. Dermatol. 17 6 (1987) 978-987
7. Campbell R.L., Bartlett A.V., Sarbaugh F.C., and Pickering L.K. Effects of diaper types on diaper dermatitis associated with diarrhea and antibiotic use in children in day care centers. Pediatr. Dermatol. 5 2 (1988) 83-87
8. Cassimos C., Kanakoudi-Tsakalidis F., Spyroglou K., Ladianos M., and Tzaphi R. Skin sensitization to 2,4-dinitrochlorobenzene (DNCB) in the first months of life. J. Clin. Lab. Immunol. 3 2 (1980) 111-113
9. Cronin M.T., Jaworska J.S., Walker J.D., Comber M.H., Watts C.D., and Worth A.P. Use of QSARs in international decision-making frameworks to predict health effects of chemical substances. Environ. Health Perspect. 111 10 (2003) 1391-1401
10. Cronin M.T.D., Walker J.D., Jaworska J., Comber M.I., Watts C.D., and Worth A.P. Use of quantitative structure-activity relationships in international decision-making frameworks to predict ecologic effects and environmental fate of chemical substances. Environ. Health Perspect. 111 10 (2003) 1376-1390
11. Cunico R.L., Maibach H.I., Khan H., and Bloom E. Skin barrier properties in the newborn. Biol. Neonate 32 (1977) 177-182
12. Davis J.A., Leyden J.J., Grove G.L., and Raynor W.J. Comparison of disposable diapers with fluff absorbent and fluff plus absorbent polymers: effects on skin hydration, skin pH, and diaper dermatitis. Pediatr. Dermatol. 6 2 (1989) 102-108
13. Epstein E. Contact dermatitis in children. Pediatr. Clin. North Am. 18 3 (1971) 839-852
14. Eriksson L., Jaworska J.S., Worth A.P., Cronin M.T., McDowell R.M., and Gramatica P. Methods for reliability and uncertainty assessment and for applicability evaluations of classification- and regression-based QSARs. Environ. Health Perspect. 111 10 (2003) 1361-1375
15. European Disposables and Nonwovens Association, 2007. Available from: (accessed November 2008).
16. EU Scientific Committee on Toxicity, 1998. Ecotoxicity and the Environment (CSTEE), Phthalate migration from soft PVC toys and child-care articles, Opinion expressed at the CSTEE third plenary meeting Brussels, 24 April, 1998.
17. Fact Book, 1996. Neue Erkenntnisse zu Physiologie und Pflege der Babyhaut, Beierdorf, A.G., consultants: Anton-Lamprecht, I., Bitzer, J., Edelmann, L., Jirásek, J.E., Linderkamp, O., Stögmann, W., Tillmanns-Bittel, A., Verveur, D., Zwinger, A., Hamburg: Beiersdorf, A.G., pp. 33.
18. Fairley J.A., and Rasmussen J.E. Comparison of stratum corneum thickness in children and adults. J. Am. Acad. Dermatol. 8 (1983) 652-654
19. Felter S.P., Ryan C.A., Basketter D.A., and Gerberick G.F. Application of the risk assessment paradigm to the induction of allergic contact dermatitis. Regul. Toxicol. Pharmacol. 37 1 (2003) 1-10
20. Felter S.P., Robinson M.K., Basketter D.A., and Gerberick G.F. A review of the scientific basis for default uncertainty factors for use in quantitative risk assessment of the induction of allergic contact dermatitis. Contact Dermatitis 47 (2002) 257-266
21. Gerberick G.F., Robinson M.K., Felter S.P., White I.R., and Basketter D.A. Understanding fragrance allergy using an exposure-based risk assessment approach. Contact Dermatitis 45 (2001) 333-340
22. Gerberick G.F., Robinson M.K., Ryan C.A., Dearman R.J., Kimber I., Basketter D.A., Wright Z., and Marks J.G. Contact allergenic potency: correlation of human and local lymph node assay data. Am. J. Contact Dermat. 12 3 (2001) 156-161
23. Ghadially R., Brown B.E., Sequeira-Martin S.M., Feingold K.R., and Elias P.M. The aged epidermal permeability barrier. J. Clin. Invest. 95 (1995) 2281-2290
24. Gotoff S.P. Infections of the neonatal infant. In: Behrmann R.E., Kliegman R.M., and Arvin A.M. (Eds). Nelson Textbook of Pediatrics. 15th ed. (1996), W.B. Saunders Company, Philadelphia, London, Toronto 514
25. In: Greim H. (Ed). Occupational Toxicants. Deutsche Forschungsgemeinschaft (1998), Wiley-VCH, Weinheim, New York,Chichester,Brisbane, Singapore, Toronto 1-29
26. Hammarlund K., and Sedin G. Transepidermal water loss in newborn infants. III. Relation to gestational age. Acta. Paediatr. Scand. 68 (1979) 795-801
27. Harpin VA., and Rutter N. Barrier properties of the newborn infant's skin. J. Pediatr. 102 (1983) 419-425
28. Herrlein, M.K., 1996. Method for assessing disposable absorbent structures, European Patent EP0797967 A1..
29. Herrlein, M.K., Robertson, M.C., Berk, A., Kleinsteuber, U., Plischke, M., 1998. Method for assessing Disposable absorbent articles, PCT World Patent A61F 13/15. International Publication number WO 98/58606.
30. Holbrook K.A. A histological comparison of infant and adult skin. In: Maibach H.I., and Boisits E.K. (Eds). Neonatal Skin, Structure and Function (1982), Marcel Dekker, Inc., New York 3-31
31. International Programme on Chemical Safety, 1999. Environmental Health Criteria 210: Principles for the Assessment of Risks to Human Health from Exposure to Chemicals. Available from: (accessed April 2007).
32. Jaworska J.S., Comber M., Auer C., and Leeuwen C.J. Summary of a Workshop on Regulatory Acceptance of (Q)SARs for Human Health and Environmental Endpoints. Environ. Health Perspect. 111 10 (2003) 1358-1360
33. Jones H.M., Parrott N., Jorga K., and Lavé T. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin. Pharmacokinet. 45 5 (2006) 511-542
34. Kalia Y.N., Nonato L.B., Lund C.H., and Guy R.H. Development of skin barrier function in premature infants. J. Invest. Dermatol. 111 (1998) 320-326
35. Krause, E., Brandt, A., Conrads-Wendtland, A., Heelis, D., Martinson, P., Mezaiti, H., Wicenec, C., 2006. TS1-11: exposure-based risk assessment principles applied to baby diapers. EDANA poster presented at the International Conference on Environmental, Epidemiology & Exposure, Paris, September 2-6, 2006.
36. Krische U. Current activities in the field of child safety within CEN and ISO. Int. J. Consum. Saf. 4 3 (1997) 119-128
37. Kroes R., Renwick A.G., Cheeseman M., Kleiner J., Mangelsdorf I., Piersma A., Schilter B., Schlatter J., van Schothorst F., Vos J.G., and Würtzen G. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food Chem. Toxicol. 42 (2004) 65-83
38. Kroes R., Kleiner J., and Renwick A. The threshold of toxicological concern concept in risk assessment. Toxicol. Sci. 86 (2005) 226-230
39. 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 Chem. Toxicol. 45 12 (2007) 2533-2562
40. Kubiak M., Kressner B., Raynor W., Davis J., and Syverson R.E. Comparison of stool containment in cloth and single-use diapers using a simulated infant feces. Pediatrics 91 (1993) 632-636
41. Lane A.T., Rehder P.A., and Helm K. Evaluations of diapers containing absorbent gelling material with conventional disposable diapers in newborn infants. Am. J. Dis. Child. 144 3 (1990) 315-318
42. Leveque J.L., Corcuff P., De Rigal J., and Agache P. In vivo studies of the evolution of physical properties of the human skin with age. Int. J. Dermatol. 23 (1984) 322-329
43. McCormack J.J., Boisits E.K., and Fisher L.B. An in vitro comparison of the permeability of adult versus neonatal skin. In: Maibach H.I., and Boisits E.K. (Eds). Neonatal Skin: Structure and Function (1982), Marcel Dekker, Inc, New York 149-164
44. National Academy of Sciences, 1983. Risk Assessment in the Federal Government. National Research Council. National Academy Press, Washington, DC.
45. Odio M., and Friedlander S.F. Diaper dermatitis and advances in diaper technology. Curr. Opin. Pediatr. 12 (2000) 342-346
46. Odio M.R., O'Connor R.J., Sarbaugh F., and Baldwin S. Continuous topical administration of a petrolatum formulation by a novel disposable diaper-1. Effect on skin surface microtopography. Dermatologica 200 (2000) 232-237
47. Odio M.R., O'Connor R.J., Sarbaugh F., and Baldwin S. Continuous topical administration of a petrolatum formulation by a novel disposable diaper-2. Effect on skin condition. Dermatologica 200 (2000) 238-243
48. OECD, 2007. OECD Quantitative Structure-Activity Relationships [(Q)SARs] Project Available from: (accessed July 2007).
49. Olsen A.R. Regulatory action criteria for filth and other extraneous materials. Reg. Toxicol. Pharmacol. 28 (1998) 181-189
50. Organisation for Economic Co-operation and Development. About Chemicals Hazard/Risk Assessment, 2007. Available from: (accessed April 2007).
51. Rasmussen J.E. Percutaneous absorption of topically applied triamcinolone in children. Arch. Dermatol. 114 8 (1978) 1165-1167
52. Renwick A.G., Dorne J.L., and Walton K. An analysis of the need for an additional uncertainty factor for infants and children. Regul. Toxicol. Pharmacol. 31 (2000) 286-296
53. Rhein L.D., Simion F.A., Hill R.L., Cagan R.H., Mattai J., and Maibach H.I. Human cutaneous response to a mixed surfactant system: role of solution phenomena in controlling surfactant irritation. Dermatologica 180 1 (1990) 18-23
54. In: Rietschel R.L., and Fowler Jr. J.F. (Eds). Contact Dermatitis. fourth ed. (1995), William & Wilkins, Baltimore 4
55. RIFM QRA Expert group, 2006. Dermal Sensitization Quantitative Risk Assessment (QRA) For Fragrance Ingredients; Technical Dossier, March 15, 2006; Revised May 26, 2006, Available from: (accessed May 2008).
56. Rimell F.L., Thome A., Stool S., Reilly J.S., Rider G., Stool D., and Wilson C.L. Characteristics of objects that cause choking in children. J. Am. Med. Assoc. 274 22 (1995) 1763-1766
57. Rook A.J., Wilkinson D.S., and Ebling F.J.G. Textbook of Dermatology. fifth ed. (1992), Blackwell Scientific Publications, Oxford
58. SCCNFP, 2002. The Scientific Committee on Cosmetic Products and Non-Food Products Intended For Consumers. Position statement on the calculation of the margin of safety of ingredients incorporated in cosmetics which may be applied to the skin of children.
59. Scientific Committee on Consumer Products, 2006. The SCCP's notes of guidance for the testing of cosmetic ingredients and their safety evaluation. 6th Revision.
60. Seymour J.L., Keswick B.H., Milligan M.C., Jordan W.P., and Hanifin J.M. Clinical and microbial effects of cloth, cellulose core/absorbent gel diapers in atopic dermatitis. Pediatrician 14 Suppl. 1 (1987) 39-43
61. Seymour J.L., Keswick B.H., Hanifin J.M., Jordan W.P., and Milligan M.C. Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis. J. Am. Acad. Dermatol. 17 6 (1987) 988-997
62. Shellow W.V., and Rapaport M.J. Comparison testing of soap irritancy using aluminum chamber and standard patch methods. Contact Dermatitis 7 2 (1981) 77-79
63. Spraker M., Krafchik B., and Leyden J. Disposable diapers: effective and safe. Contemp. Pediatr. Suppl. Mar. 2000 (2000) 4-18
64. UK Environment Agency, 2005. Life-cycle assessment of disposable and reusable nappies in the UK. Available from: .
65. US EPA, 1993. Reference Dose (RfD): description and use in health risk assessments. IRIS Background Document 1A. Available from: .
66. US EPA, 2002. A Review of the Reference Dose and Reference Concentration Processes (PDF) (192 pp, 2.8 M). EPA/630/P-02/002F.
67. Van R., Morrow A.L., Reves R.R., and Pickering L.K. Environmental contamination in child day-care centers. Am. J. Epidemiol. 133 (1991) 460-470
68. Van R., Wun C.C., Morrow A.L., and Pickering L.K. The effect of diaper type and overclothing on fecal contamination in day-care centers. J. Am. Med. Assoc. 265 (1991) 1840-1844
69. van Prooijen R.J.L., and de Winter P.E. Structural integrity assessment and testing, Int. J. Consum. Saf. 3(I) (1996) 31-38
70. Veith, G.D., 2006. Roles for QSAR in risk assessment. Proceedings of the 5th World Congress on Alternatives and Animal Use in the Life Sciences, Berlin 2005. ALTEX 23, 369-372.
71. West D.P., Worobec S., and Solomon L.M. Pharmacology and toxicology of infant skin. J. Invest. Dermatol. 76 (1981) 147-150
72. Wester R.C., and Maibach H.I. Comparative percutaneous absorption. In: Maibach H.I., and Boisits E.K. (Eds). Neonatal Skin: Structure and Function (1982), Marcel Dekker, Inc, New York 137-147
73. Wilson P.A., and Dallas M.J. Diaper performance: maintenance of healthy skin. Pediatr. Dermatol. 7 3 (1990) 179-184