Measurement of Relative Skin

Irritation of Pampers Dry Max

Disposable Diapers
Authors: JEREMIAH McNICHOLS, JENNIFER McNICHOLS
Published: Z Recommends, July 2010

Introduction
The testing of disposable diapers, like that of most other personal care
products, is an expensive, intensive, and in many ways exhaustive process.
Supplier-produced data sheets guide the selection of materials, and samples
of working and final products are tested on animals, on adult subjects and,
in the case of diapers, ultimately on babies during in-home trials. New
formulations are also released onto the market for a trial period prior to
announcing changes, at least in part to identify and respond to any problems
with revised products in as quiet a manner as possible.

At the same time, U.S. consumers know much less about what is in
disposable diapers than they do about most other products on supermarket
shelves. Unlike personal care products like shampoo and toothpaste, the
disclosure of ingredients in diapers is not required by law, and the chemicals
and materials used in them are typically a closely guarded trade secret.
Bleaching agents, surfactants, adhesives, glues, and lotion ingredients
include a variety of potential skin irritants,1 and plastics or lotions may
contain any number of potentially harmful ingredients, byproducts, or
contaminants, including dioxin and Tributyl-tin2, although the significance of
the levels of these contaminants found in consumer products have been
challenged3. Fragrances are employed regionally based on market research,
with no indication on packaging of whether the diapers they contain are
scented or unscented, and formulations are changed (routinely, some
industry representatives have claimed4) months or years before any
announcement 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_CBC
2. "Chronology of findings of organotin compounds including TBT (Tributyltin) in various
non-food consumer products," Mindfully.org. http://bit.ly/Pampers_TBT
3. "Exposure assessment to dioxins from the use of tampons and diapers," Environmental
Health Perspectives, January 2002. http://bit.ly/Diapers_Dioxins
4. "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 consumers
began reporting unusual problems with one specific brand of diaper,
Pampers, after the company changed the absorbent core to a new
formulation it calls "Dry Max." The new core substitutes some of the
previously used wood pulp for sodium polyacrylate, a superabsorbent
polymer, uses an adhesive to affix the sodium polyacrylate to the interior
surface of the diaper, and uses an additional dye to give the diaper's inner
surface a lavender hue. However, the company maintains that its own
testing suggests that the new diaper causes no greater incidence or severity
of rashes than the previous diaper design.

Pampers representatives have maintained to us that diaper rash is caused

exclusively by skin exposure to enzymes from bowel movements (BM), de-
emphasizing the role of chemical exposure, abrasion, or any other diaper
feature, but the American Academy of Pediatrics has recently added allergic
reactions to diaper materials and chafing or rubbing to its list of possible
causes of rashes ranging from mild irritation to open sores 5.

Changes to the design and formulation of popular consumer products often

lead to a temporary increase in consumer complaints, and companies have
learned to account for such events in marketing and evaluating the
effectiveness of new products. The result is a deliberate desensitization to
consumer complaints during an initial roll-out period, often accompanied by
detailed modeling of anticipated responses and their persistence prior to
consumer acceptance of the change. This attitude of "weathering the storm"
can ensure that customers loyal to an old design have sufficient opportunity
to acclimate to changes, and since this period is often preceded by
significant testing and piloting of new products among selected consumers,
most companies which engage in such practices are quite confident in their
models.

The emergence and adoption of new technologies for rapidly sharing

information (Twitter, Facebook, Blogger, and StumbleUpon among them)
poses new challenges to this philosophy, as the widened circle of influence
among dissatisfied consumers can result in group behavior based on fewer
individual experiences than ever before. As once-isolated individuals form
temporary communities around specific topics of interest, they may form
assumptions about the representative nature of their experience. These
assumptions 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 their
experiences) or underestimation (as the true numbers must include many
individuals who have not found the group or lack the motivation or means to
participate).

When the topic involves the potential harmful effects of a product, such a
community quickly comes into adversarial conflict with a company that has
conducted internal testing and believes their product to meet existing
standards and (thus) to be defensibly safe. As this conversation
deteriorated, with each side forced by circumstances to do its best to
undermine the credibility of the other, the Consumer Product Safety
Commission stepped in and promised a thorough review of Pampers' internal
documentation of the issue.

We decided to pit the previous and new designs in head-to-head testing that
would, regardless of the significance of specific levels of irritation caused by
either diaper, offer a simple comparison of the two for consumers seeking
more facts than were currently being put on the table. In so doing, we
hoped to identify whether Dry Max diapers might cause more significant or
longer-lasting rashes than pre-Dry Max Pampers.

Procedure
Disposable diaper testing exposes adult test subjects to extreme conditions
to generate magnified responses. They do this using actual urine and actual
bowel movements (BM) held against the skin for periods ranging from
several hours to several days. The exaggerated responses that are
generated are then rated against norms using complex statistical models
and dermatological assessments. We chose to mimic these procedures using
synthetic and actual urine as well as infant BM.

Patch testing was conducted in three rounds. Since comparative results were
sought, we were comfortable adjusting variables between trials to magnify
overall results, provide additional comfort for the human subject, or respond
to recommendations from readers. Examples of changes included reducing
the size of diaper patches from a 1" strip of the full width of the diaper to a
roughly 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 BM
for testing, as described in detail below.

Patches were cut from the central fill area of diapers and any open edges
sealed with paper bandage tape. Diaper samples were affixed to the
forearms and, in the case of dry patches, upper arms of the human subject
using paper bandage tape.
In the first BM trial, small amounts of fresh infant stool were applied to
patches and taped to the skin. This BM had been collected in a formerly
clean pre-fold cotton diaper and stored in a plastic ziploc-style bag, but had
been somewhat dehydrated by the liquid being absorbed by the diaper.

In the second BM trial, we attempted to better "reconstitute" the relatively

dry BM. To do this, we acquired a clean prefold diaper from the same
provider as the BM sample; after scraping the BM diaper as clean as
possible, we weighed the liquid-containing dirty pre-fold and the clean one.
The difference in weight (in grams) was added back to the BM in the form of
urine. This provided the BM with a wetter texture more consistent with
"fresh" BM prior to having liquid wicked away from it by a diaper. We also
took the opportunity to puree the feces and urine to a smooth consistency
using a disposable polypropylene plastic fork, which ensured that the BM had
an even consistency with no particulates that might cause greater or lesser
irritation in different samples. A measured amount (1 tsp) of this slurry was
then applied to the center of the patch and taped to the subject's arm.

For each trial, samples were left taped to the test subject's arms with rare
disturbance for a period of eight to nine hours while the subject engaged in
what limited routine activities were still available to him. All patches were
then removed, the subject's arms were gently and carefully washed with a
hypoallergenic soap (Dr. Bronner's Unscented Mild Baby Soap), photographs
were taken, and rashes were comparatively assessed by an individual with
no knowledge of the positioning of individual patches.

Diaper Specifications

All diaper types were used in every round with the exception of the single
cloth diaper sample introduced in the last round of testing as an additional
control.

Purchase Scented/
Sample Tracking date Purchase Unscented
brand and Information month Location blind smell
style code on diaper and year state or online test

Pre-Dry Max
9013U011301531 June 2008 Massachusetts Scented
Cruiser
Dry Max
00864840040728 April 2010 Online Unscented
Cruiser ("A")
Dry Max
0113U017540403 May 2010 Texas Scented
Cruiser ("B")
Huggies Snug (c)2009 KCWW
May 2010 Texas Unscented
& Dry 3E
 January
Kushies all-in-
N/A 2005 Online N/A
one
(estimate)

Assessing Irritation

Two types of irritation were seen, which must be treated differently as they
cannot be rated along a single continuum.

Initial irritation seen immediately after removal of patches differed

significantly, and in all cases was at its most pronounced after skin was
gently washed with a hypoallergenic soap to remove any trace of sample
materials. The presence of warm water, gentle friction, and exposure to air
mimic initial steps likely taken by parents to address infant rashes, and
examination of these rashes yielded several qualitative differences that could
be used to classify rashes by their relative levels of irritation.

As all irritation described in this study is relative, judgments of "severity"

were avoided. Thus, a "High" rash response is not intended to connote a
given level of significance or harm, but simply that, relative to other rash
responses, it was the highest gradation seen. The following descriptive
definitions may be helpful in assessing levels of skin irritation on an
individual basis.

0 = No visible rash whatsoever

1 = Low: Very slight visible rash, scattered dots to splotchy distribution
2 = Low to Moderate: Pink coloration, splotchy distribution
3 = Moderate: Pink coloration, splotchy to uniform distribution, some
definition of rash edges, slightly raised areas of skin
4 = Moderate to High: Pink to red coloration, uniform distribution, defined
rash edges, some raised areas of skin
5 = High: Red coloration, uniform distribution, sharply raised edges, welted
appearance with swollen skin throughout

Initial irritation typically subsided 90-100% within 12 hours of patch

removal.

Extended irritation was in some ways less pronounced than initial

irritation, but in other ways more pronounced. Descriptively, it consisted of
subtle, firm, raised bumps on the skin that could easily be felt with the
fingertips and also visually identified. These bumps were not painful, and
were lighter in color than the rashes that preceded them, but persisted for
24 hours or more after all initial irritation had subsided. As this distinct type
of irritation was only present in rare cases, it could not easily be classified in
terms of gradation; instead, we chose to log its presence or absence alone
as an indicator of rash activity, and treat it as a boost of +3 to the relative
significance of a rash, as it is assumed to be an indicator of more significant
skin sensitivity or vulnerability to persistent rash, recurrent rash, or eventual
infection after prolonged exposure.

Levels of initial irritation were assigned by a research assistant with no

knowledge of sample positions for each trial. Extended irritation was noted in
identical locations by multiple parties without coaching or direction.

Results
Dry Patches

Diaper Type Irritation Level

Pre-Dry Max Cruiser 0

Dry Max Cruiser A 0

Dry Max Cruiser B 0

Huggies Snug & Dry 0

Wet Patches (Urine or Synthetic Urine)

Diaper Type 1st Trial 2nd Trial

synthetic urine human urine

Pre-Dry Max Cruiser 0 0

Dry Max Cruiser A 2 0

Dry Max Cruiser B 0 0

Huggies Snug & Dry 0 0

Soiled Patches

2nd
Average
1st Trial 1st Trial Trial 2nd Trial
Diaper irritation
infant BM rash BM/urine rash
Type of all
persistence mixture persistence
soiled
24 hours (Sample 24 hours
samples
later 1, 2 if later
present)

Pre-Dry
Max 4 No 4, 2 No, No 3.33
Cruiser
Dry Max
5 Yes 2, 3 Yes, No 3.33
Cruiser A

Dry Max
4 No 2, 4 No, No 3.33
Cruiser B

Huggies
Snug & 4 No 1 No 2.5
Dry

Kushies
Cloth N/A N/A 0 No 0
Diaper

Average Irritation from Wet (Urine) and Soiled (BM and Urine/BM)
Trials

Diaper Type Total Samples Average

Pre-Dry Max Cruiser 5 2

Dry Max Cruiser A 5 2.4

Dry Max Cruiser B 5 2

Huggies Snug & Dry 4 1.25

Kushies Cloth Diaper 1 0

Conclusions
We believe the most significant finding of our study is its demonstration
that, when compared with a leading competitor or its own previous
formulation, Pampers with Dry Max are more likely to cause extended
irritation persisting long after the diaper is changed. Examining the
behavior of this rash when the skin is repeatedly re-covered with another
diaper which is then soiled or wetted on top of the persistent rash, was
beyond the scope of this study; but it does not feel excessively speculative
to posit that a rash so treated would be more likely to deteriorate further
than skin that showed no signs of being compromised.

A more troubling finding, and a highly illuminating one, is that beyond

this overall difference in performance, Dry Max Pampers from two
different "batches" were associated with different levels of both
initial and extended irritation. These differences were documented both
by a blinded "scent test" and by their tracking codes. The batch linked to all
cases of extended irritation, and which triggered the sole reaction to a urine-
containing diaper in this study, was the batch that had been acquired from a
consumer whose own child had suffered from severe diaper rash while
wearing diapers from the same package.

Here is a complete rundown of our conclusions from this study:

 • Wet and soiled Pampers diapers with the Dry Max absorbent
core caused slightly higher average levels of initial
irritation than the previous formulation of Pampers diapers.

• Dramatic differences in extended irritation were documented

at a 24-hour interval between Pampers Dry Max and the
previous Pampers formulation. Specifically, extended irritation was
seen with two Pampers Dry Max samples, but not with any other
diaper sample by any brand in this study.

• Extended irritation was documented exclusively in one of two

Pampers Dry Max sources used in this study. Patches that
triggered extended irritation were taken from diapers in a package
that had caused significant rash activity in a child. Diapers from this
sample triggered this response in both BM trials. The fact that this
same batch of Pampers with Dry Max was correlated with the sole
case of irritation caused in our urine trials is both surprising and
suggestive. These diapers appeared to be unscented, compared with
the strong fragrance of the samples we purchased locally.

• Variations in initial irritation found between Pampers and

Huggies, and between Pampers and cloth diapers, are
intriguing but inconclusive. Huggies patches used the same urine
and BM content, and all diapers showed reduced initial irritation with
our BM/urine slurry than with BM alone. But the significantly lower
result of the Huggies patch's second BM test may have been caused
by the diaper's position, as it was rotated around the forearm towards
the elbow. Given that this result significantly depresses the average
irritation scoring of Huggies' smaller sample size, and that a single
cloth diaper sample performed equally well, more testing would be
needed to explore these possibilities.

Discussion
What's behind the rashes?

Identifying the underlying cause behind the extended irritation linked to

Pampers Dry Max diapers is beyond the scope of this study. The cause could
be mechanical (a more abrasive interior diaper surface, excess dessication of
the skin, or poor breathability), chemical (changes to levels of ingredients
previously present, new or modified ingredients, or contaminated
ingredients), or some combination of these.

As mentioned above, this problem does not appear to be uniformly present

in Dry Max diapers. Samples from one package regularly performed as well
as or almost as well as pre-Dry Max diapers, while the other caused
extended irritation in multiple instances, in different locations on the subject,
which were not linked to any other sample set. Add two facts - first, that no
reaction was noted in connection with dry patch tests, and second, that the
extended irritation we saw presented earlier than one would expect of an
allergic response - and our data paints a highly suggestive picture of
variability in the production process, whether based on an evolving product
design, regional or manufacturing-facility variations, or the challenges in
mastering and refining new manufacturing processes. The possible presence
of these differences offers a lens through which to view the dramatically
divergent experiences reported by parents regarding Dry Max diapers, and
one that is not allergy-based.

Limitations of the study

There were several limitations to these tests, though most were anticipated.
All testing was conducted on a single adult subject, whose skin sensitivity
may differ from that of infants or other adults. Eight-hour trials of urine- and
fecal-loaded diaper patches were difficult to coordinate and conduct, limiting
us to three rounds of testing. And some samples were positioned in unusual
ways - one of our Huggies samples, for example, and our sole cloth diaper
sample, were positioned on an area of the inner forearm which, in
retrospect, might have decreased sensitivity. We accommodated these
limitations to the best of our ability through our testing procedures and our
interpretation of the results.

Recommendations for follow-up testing

We see several opportunities for others who might like to pursue similar or
additional testing.

We believe testing should be conducted at an independent third party

laboratory, bringing to bear expertise in skin patch testing. Ingredients in
the diapers should be professionally and chemically analyzed, and diapers
should be comparatively tested in additional adult subjects (or infants, if
available) by a third party.

Additionally, a comparative skin irritation test of cloth and disposable

diapers, using multiple adult subjects, infant BM, and several trials, could
yield interesting results.