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Measurement of Relative SkinIrritation of Pampers Dry MaxDisposable Diapers
Authors:
JEREMIAHMcNICHOLS, JENNIFERMcNICHOLS
Published:
Z Recommends, July 2010
Introduction
The testing of disposable diapers, like that of most other personal careproducts, is an expensive, intensive, and in many ways exhaustive process.Supplier-produced data sheets guide the selection of materials, and samplesof working and final products are tested on animals, on adult subjects and,in the case of diapers, ultimately on babies during in-home trials. Newformulations are also released onto the market for a trial period prior toannouncing changes, at least in part to identify and respond to any problemswith revised products in as quiet a manner as possible.At the same time, U.S. consumers know much less about what is indisposable diapers than they do about most other products on supermarketshelves. Unlike personal care products like shampoo and toothpaste, thedisclosure of ingredients in diapers is not required by law, and the chemicalsand materials used in them are typically a closely guarded trade secret.Bleaching agents, surfactants, adhesives, glues, and lotion ingredientsinclude a variety of potential skin irritants,
1
and plastics or lotions maycontain any number of potentially harmful ingredients, byproducts, orcontaminants, including dioxin andTributyl-tin
2
, although the significance of the levels of these contaminants found in consumer products have beenchallenged
3
. Fragrances are employed regionally based on market research,with no indication on packaging of whether the diapers they contain arescented or unscented, and formulations are changed (routinely, someindustry representatives have claimed
4
) months or years before anyannouncement is made. The disposable diaper industry is self-policing in its
1."Disposable diapers: Are they dangerous?" CBC News, May 28, 2010. http://bit.ly/Pampers_CBC2."Chronology of findings of organotin compounds including TBT (Tributyltin) in variousnon-food consumer products," Mindfully.org. http://bit.ly/Pampers_TBT3."Exposure assessment to dioxins from the use of tampons and diapers," EnvironmentalHealth Perspectives, January 2002. http://bit.ly/Diapers_Dioxins4."Pampers, on the record: An interview with Jodi Allen," Z Recommends, July 3, 2010.http://bit.ly/ZRecs_Allen
 
compliance with existing regulatory standards.This knowledge gap was brought into sharp relief in the latter months of 2009 and the first half of 2010, when an increasing number of consumersbegan reporting unusual problems with one specific brand of diaper,Pampers, after the company changed the absorbent core to a newformulation it calls "Dry Max." The new core substitutes some of thepreviously used wood pulp for sodiumpolyacrylate, asuperabsorbentpolymer, uses an adhesive to affix the sodiumpolyacrylateto the interiorsurface of the diaper, and uses an additional dye to give the diaper's innersurface a lavender hue. However, the company maintains that its owntesting suggests that the new diaper causes no greater incidence or severityof rashes than the previous diaper design.Pampers representatives have maintained to us that diaper rash is causedexclusively by skin exposure to enzymes from bowel movements (BM), de-emphasizing the role of chemical exposure, abrasion, or any other diaperfeature, but the American Academy of Pediatrics has recently added allergicreactions to diaper materials and chafing or rubbing to its list of possiblecauses of rashes ranging from mild irritation to open sores
5
.Changes to the design and formulation of popular consumer products oftenlead to a temporary increase in consumer complaints, and companies havelearned to account for such events in marketing and evaluating theeffectiveness of new products. The result is a deliberate desensitization toconsumer complaints during an initial roll-out period, often accompanied bydetailed modeling of anticipated responses and their persistence prior toconsumer acceptance of the change. This attitude of "weathering the storm"can ensure that customers loyal to an old design have sufficient opportunityto acclimate to changes, and since this period is often preceded bysignificant testing and piloting of new products among selected consumers,most companies which engage in such practices are quite confident in theirmodels.The emergence and adoption of new technologies for rapidly sharinginformation (Twitter,Facebook, Blogger, andStumbleUponamong them)poses new challenges to this philosophy, as the widened circle of influenceamong dissatisfied consumers can result in group behavior based on fewerindividual experiences than ever before. As once-isolated individuals formtemporary communities around specific topics of interest, they may formassumptions about the representative nature of their experience. Theseassumptions may involve overestimation (as can happen with any group of 
5."Diaper Rash," Patient Education Online, American Academy of Pediatrics, 2010.http://bit.ly/AAP_DiaperRash
 
like-minded individuals surrounding themselves with those who share theirexperiences) or underestimation (as the true numbers must include manyindividuals who have not found the group or lack the motivation or means toparticipate).When the topic involves the potential harmful effects of a product, such acommunity quickly comes into adversarial conflict with a company that hasconducted internal testing and believes their product to meet existingstandards and (thus) to be defensibly safe.As this conversationdeteriorated, with each side forced by circumstances to do its best toundermine the credibility of the other, the Consumer Product SafetyCommission stepped in and promised a thorough review of Pampers' internaldocumentation of the issue.We decided to pit the previous and new designs in head-to-head testing thatwould, regardless of the significance of specific levels of irritation caused byeither diaper, offer a simple
comparison of the two
for consumers seekingmore facts than were currently being put on the table. In so doing, wehoped to identify whether Dry Max diapers might cause more significant orlonger-lasting rashes than pre-Dry Max Pampers.
Procedure
Disposable diaper testing exposes adult test subjects to extreme conditionsto generate magnified responses. They do this using actual urine and actualbowel movements (BM) held against the skin for periods ranging fromseveral hours to several days. The exaggerated responses that aregenerated are thenrated against norms using complex statistical modelsand dermatological assessments.We chose to mimic these procedures usingsynthetic and actual urine as well as infant BM.Patch testing was conducted in three rounds. Since comparative results weresought, we were comfortable adjusting variables between trials to magnifyoverall results, provide additional comfort for the human subject, or respondto recommendations from readers. Examples of changes included reducingthe size of diaper patches from a 1" strip of the full width of the diaper to aroughly 1.5" square; the elimination of dry patches after the first round of testing, as they showed no response; and the method of preparing infant BMfor testing, as described in detail below.Patches were cut from the central fill area of diapers and any open edgessealed with paper bandage tape. Diaper samples were affixed to theforearms and, in the case of dry patches, upper arms of the human subjectusing paper bandage tape.
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