Clinical and Experimental Studies
Received: June 10, 2003
Exog Dermatol 2003;2:195–200
DOI: 10.1159/000076801
AISI 316L Stainless-Steel Ear Piercing
Post Assembly Does Not Cause
Dermatitis in Nickel-Sensitive Subjects
Arieh Ingber Klilah Hershko Liran Horev
Department of Dermatology, Hadassah University Hospital, Ein Kerem, Faculty of Medicine, Hebrew University,
Jerusalem, Israel
Key Words
Contact dermatitis W Ear piercing W Nickel W Stainless steel
Abstract
Twenty-three female and 2 male subjects, documented
to be sensitive to nickel by history and diagnostic patch
testing, were pierced with American Iron Steel Institute
(AISI) 316L stainless-steel ear piercing post assemblies
(The Ear Piercing Manufacturers of Europe, UK), AISI
316L having a specification that includes a nickel content
of between 10 and 14%. After piercing, the subjects were
examined on days 7, 14, 30 and 42. Seven of the ear
piercing post assemblies collected at random from the
subjects at the end of the study and 10 unused post
assemblies selected at random were analysed for nickel
content and release. None of the nickel-sensitive patients
showed signs of nickel dermatitis during the study. The
nickel content of the ear piercing post assemblies col-
lected from patients was reported as being between 11.5
and 12.9%, and the calculated rate of nickel release was
below the detection limit of the method, thus recorded at
!0.05 Ìg/cm2/week. By comparison, the nickel content of
the unused post assemblies was reported to be between
9.93 and 10.5%, and the calculated rate of nickel release
© 2003 S. Karger AG, Basel
ABC 1424–4616/03/0024–0195$19.50/0
Fax + 41 61 306 12 34
E-Mail karger@karger.ch Accessible online at:
www.karger.com www.karger.com/exd
Accepted after revision: October 10, 2003
was between 0.11 and 0.21 (mean: 0.15) Ìg/cm2/week.
These results suggest that the AISI 316L stainless-steel
ear piercing post assemblies do not elicit adverse reac-
tions to nickel in previously sensitized subjects.
Copyright © 2003 S. Karger AG, Basel
Introduction
The risk of sensitization to nickel after ear piercing is
very high [1, 2]. One of the first countries to implement
regulations aimed at reducing the risk of sensitizing con-
sumers to nickel by items in contact with the skin was
Denmark [3]. Likewise, Sweden introduced regulations
limiting the nickel content in ear piercing materials. In
Germany, the labelling of nickel-containing items in-
tended for contact with the skin was made compulsory
[4, 5].
A study conducted by Menné [6] found that the elicita-
tion of nickel dermatitis was common in alloys releasing
more than 1 Ìg/cm2/week and rare in alloys releasing less
than 0.5 Ìg/cm2/week. In most cases, the level of 0.5 Ìg/
cm2/week is considered to be below the threshold of con-
centrations sufficient to cause exacerbation of dermatitis
in subjects already sensitized to nickel or to cause de novo
Arieh Ingber
Department of Dermatology, Hadassah University Hospital
Ein Kerem Faculty of Medicine, Hebrew University
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Jerusalem (Israel)
Tel. +972 2 6776366, Fax +972 2 6426756, E-Mail fjonas@hadassah.org.il
Univ. of California San Diego
Downloaded by:
sensitization in people who were not previously sensi-
tized, although it may occasionally cause contact dermati-
tis in people already sensitized [3].
Directive 94/27/EC published by the European Com-
mission states that the nickel content in ear piercing post
assemblies or jewellery used to pierce the skin and
intended to remain in place throughout the epithelization
period must be less than 0.05% mass to total mass [7, 8].
This directive was implemented in July 2000.
Stainless steel is characterized by an almost poreless
chromium oxide surface which prevents the nickel from
being released. Numerous studies have investigated the
relationship between nickel release from stainless-steel
alloys and reactivity in nickel-sensitive patients as deter-
mined by patch testing. High-grade stainless steel has an
increased resistance to corrosion and releases nickel in
quantities that can hardly be detected [9–11]. The aim of
the present study was to determine the reactivity of nick-
el-sensitive subjects to AISI 316L stainless-steel ear pierc-
ing post assemblies.
Materials and Methods
Twenty-three female and 2 male patients known to be nickel sen-
sitive by history and patch tests formed the study group (table 1).
Exclusion criteria were age under 18 and pregnancy. The patients
were recruited from a large pool of subjects known to have nickel
sensitivity. Prior to the study, all of the patients had at some point
developed nickel contact dermatitis, and none of the patients had
been able to wear high-nickel-releasing alloys without experiencing a
reaction.
No participant was using systemic steroids or had been on anti-
histamine treatment at least 1 month prior to the start of the study or
any other local treatment to the ear lobes at least 3 days before start-
ing the study. Following approval by the Institutional Ethical Com-
mittee, the subjects with a history of nickel sensitivity were patch
tested with the Standard European Series (Chemotechnique Diag-
nostics, Sweden). The application time was 2 days, and readings were
performed 2 and 4 days after application, according to the ICDRG
[12]. Only patients showing a clear positive reaction to nickel [13]
remained in the study.
Identical-looking AISI 316L stainless-steel post assemblies (man-
ufactured by Studex Corporation) were inserted into the ear lobe
after cleaning with 70% alcohol. The subjects were examined on days
7, 14, 30 and 42 by a dermatologist. The subjects were encouraged to
contact the study coordinators at any time if problems arose between
the scheduled examinations. On day 42, all the post assemblies were
removed, and, at random, 7 of them were submitted for testing to
Sheffield Analytical Services, UK, for nickel content and release
analysis. Sheffield Analytical Services, which received its charter
from the UK government, was chosen to conduct the nickel tests
because as one of the premier testing houses in the UK, they have a
vast amount of experience in testing products for compliance with
the Nickel Directive. The ear piercing manufacturers had initially
196 Exog Dermatol 2003;2:195–200
provided more ear piercing post assemblies than were actually
needed for the study. Ten of these unused ear piercing post assem-
blies were chosen at random and were also submitted for nickel
release and content tests. A chemical analysis was also performed on
the ear piercing post assemblies.
Analytical Methods
Nickel Content Test
Sheffield Analytical Services reported the following method for
nickel content testing. A sample of a test piece was dissolved in min-
eral acids, HCl:HNO3 mixture. These solutions of dissolved sample
and acids were made to volume and analysed using an inductively
coupled plasma-optical emission spectrometer (ICP-OES). The nick-
el content was determined using the spectral emission intensities of
nickel at 231.003 and 341.476 nm. To ensure correct performance of
the instrument, control solutions were analysed that contained accu-
rate amounts of independently certified nickel. The analysis result
for each sample was also assessed to ensure freedom from spectral
interferences. A summary of the ICP-OES and a brief description of
the procedure to calibrate is contained in Appendix 1.
Nickel Release BS EN 1811:1999 – Principle
Sheffield Analytical Services reported the following method for
nickel release testing. This method was followed closely.
The ear piercing post assemblies were tested as one piece. The
surface areas were measured and recorded. The post assemblies were
suspended in a volume of sweat solution sufficient to totally immerse
the post assemblies in the solution for a period of 168 h at a tempera-
ture of 30 B 2 ° C. It is important to ensure that each article is fully
immersed to guarantee that air, liquid and metal surface corrosion
effects are not permitted to influence the procedure. The volumes
used with the samples in this case were in excess of that recom-
mended by BS EN 1811:1999 of 1 ml of test solution per square cen-
timetre sample surface area because of the requirement to suspend
and immerse. However, the difference between the recommended
volume to that achieved practically was not sufficient to affect the
final test result, the analytical limit of detection being better than
0.01 mg/l.
Following this the post assemblies were removed from the vessels
and rinsed with deionized water back into the vessels. In order to
prevent redeposition of dissolved nickel, a drop of nitric acid (AR,
conc.) was added to each vessel. The volume of solution in these ves-
sels was then recorded. Test pieces of a known release rate were
tested alongside the post assemblies following the same procedure.
Blanks and control standards were also analysed by the ICP-OES
analytical procedure (see Appendix 1). The results were recorded,
calculated and reported. All analytical corrections were accounted
for (including surface area, volume of final solution, instrument
response), and a limit of detection was determined, the concentration
of dissolved nickel in the solution being determined by ICP-OES.
The nickel release is expressed in microgrammes per square centi-
metre per week. These reagents and procedures are detailed in BS EN
1811:1999 [14].
In order to even out the differences between laboratories, analysts
and equipment performing nickel release tests all over the EC as
required by the Nickel Directive, the actual results from the nickel
release test (EN 1811) are multiplied by 0.1, also known as the correc-
tion factor. In order to get a truer picture of the release figures, the
actual calculated nickel release values without applying the correc-
tion factor are reported in the tables.
Ingber/Hershko/Horev
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Table 1. Clinical data and study results

No. Age Gender History and clinical symptoms1 Patch test2 Study results on the ear lobes
years reactions

1 36 Female Ear lobe dermatitis and hand eczema Nickel +2 No dermatitis

2 21 Female Ear lobe dermatitis, neck dermatitis Nickel +1 No dermatitis, transient itch and
erythema for 48 h after piercing3
3 24 Female Hand eczema, exacerbation from finger ring Nickel +1 No dermatitis
4 49 Female Ear lobe and hand dermatitis Nickel +1 No dermatitis
5 35 Male Hand eczema when in contact with metals Nickel +1 No dermatitis
Chrome +1
Cobalt +1
6 35 Female Hand and ear lobe dermatitis Nickel +1 No dermatitis
7 25 Female Eyelid dermatitis when in contact with earrings Nickel +1 No dermatitis
8 30 Female Hand eczema when in contact with metals Nickel +1 No dermatitis
9 36 Female Ear lobe dermatitis, ‘jeans’ dermatitis due to metal button Nickel +2 No dermatitis
10 23 Female Ear lobe dermatitis Nickel +2 No dermatitis
11 29 Female Ear lobe dermatitis Nickel +1 No dermatitis
12 22 Female Ear lobe dermatitis Nickel +2 No dermatitis
13 29 Female Ear lobe dermatitis Nickel +1 No dermatitis
14 18 Male Ear lobe dermatitis under watch dermatitis Nickel +1 No dermatitis
15 33 Female Ear lobe dermatitis Nickel +1 No dermatitis
16 23 Female Ear lobe dermatitis Nickel +2 No dermatitis
17 23 Female Ear lobe dermatitis Nickel +2 No dermatitis, transient itch and
erythema for 48 h after piercing3
18 48 Female Ear lobe dermatitis, finger ring dermatitis Nickel +3 No dermatitis
19 45 Female Ear lobe dermatitis Nickel +2 No dermatitis
20 42 Female Ear lobe dermatitis Nickel +2 No dermatitis
21 18 Female Ear lobe dermatitis Nickel +2 No dermatitis
22 20 Female Ear lobe and hand eczema Nickel +3 No dermatitis
Chrome +2
23 25 Female Ear lobe dermatitis Nickel +1 No dermatitis
24 30 Female Ear lobe dermatitis Nickel +1 No dermatitis
25 19 Female Ear lobe dermatitis Nickel +1 No dermatitis

1 Ear lobe dermatitis was all historical, some hand eczema was current (No. 1 and 3).
2 Patch tests prior to the current piercing.
3 Described symptoms were not a display of clinically significant allergic contact dermatitis.

Results All patients subjected to a patch test showed a positive

The age of the participants was 18–48 years; 21 had a
history of ear lobe dermatitis to non-gold jewellery. One
patient (No. 3) had hand eczema that became worse when
wearing a non-gold finger ring. No. 5, a male patient, is
employed as a barman, and his hand eczema appeared
when he was in contact with metals. Patient No. 7 had
eyelid dermatitis, in particular when she wore metal ear-
rings. Patient No. 8, employed as a cashier, suffered from
hand eczema, aggravating upon contact with Israeli coins
of 1 and 5 shekels which are known to have a high nickel
content.
reaction to nickel (table 1). By contrast, none of the 25
subjects developed dermatitis during the study. Two pa-
tients had slight ear lobe itching and erythema after the
piercing. These symptoms resolved completely after 2
days. These slight symptoms were not a display of clinical-
ly significant contact dermatitis. We interpreted these
transient symptoms as the result of physical trauma to the
ear lobe caused by holding, clothing or pulling the ear lobe
while piercing.
The nickel content of the 7 posts tested (table 2) was
reported to be between 11.5 and 12.9% of the total mass.
The calculated nickel release was below the detection

AISI 316L Stainless-Steel Ear Piercing and Exog Dermatol 2003;2:195–200 197
Nickel Sensitivity
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Table 2. Nickel content and release in
Sample Area of post Final volume of Analytical value of Calculated value of Ni content
7 used ear piercing post assemblies tested No. assembly, cm2 artificial sweat, cm3 Ni in solution, ppm Ni, Ìg/cm2/week %

1 1.018 5.784 0.000695 ! 0.05 11.5

2 1.018 5.575 0.000962 ! 0.05 11.7
3 1.018 4.919 0.000715 ! 0.05 11.7
4 1.018 4.731 0.000747 ! 0.05 11.7
5 1.018 5.282 0.000984 ! 0.05 12.1
6 1.018 4.388 0.000361 ! 0.05 12.9
7 1.018 8.123 0.000398 ! 0.05 11.9

Calculated Ni values: results below the detection limit (tested according to EN 1811); the
limit of accurate detection was better than 0.08 Ìg/cm2/week, the instrument limit of detec-
tion was 0.007 mg/l. Ni content tested according to UKAS (ISO/IEC 17025) accredited proce-
dures.

Table 3. Nickel content and release in

Sample Area of post Final volume of Analytical value of Calculated value of Ni content
10 unused posts tested No. assembly, cm2 artificial sweat, cm3 Ni in solution, ppm Ni, Ìg/cm2/week %

1 1.018 10.076 0.017 0.15 10.2

2 1.018 12.169 0.012 0.13 10.1
3 1.018 10.983 0.015 0.14 10.5
4 1.018 12.868 0.010 0.11 10.2
5 1.018 11.935 0.014 0.14 10.1
6 1.018 11.343 0.012 0.12 10.1
7 1.018 10.199 0.022 0.19 10.1
8 1.018 12.076 0.020 0.18 10.2
9 1.018 10.768 0.018 0.21 9.93
10 1.018 12.763 0.016 0.17 10.3

Calculated Ni values tested according to BS EN 1811:1999; the limit of accurate detection

was better than 0.08 Ìg/cm2/week, the instrument limit of detection was 0.007 mg/l. Ni con-
tent tested according to UKAS (ISO/IEC 17025) accredited procedures.

limit and was reported as !0.05 Ìg/cm2/week. The nickel Discussion

content of the 10 unused post assemblies tested (table 3)
was reported to be between 9.93 and 10.5% mass to total
mass. The calculated nickel release was reported as be-
tween 0.11 and 0.21 (mean: 0.15) Ìg/cm2/week. Sheffield
Analytical Services also reported that a chemical analysis
of the post assemblies showed the metal content of the
post assemblies to be consistent with the composition
specifications of AISI (American Iron Steel Institute)
316L (table 4).
AISI 316L is a nickel-containing stainless-steel alloy
considered to be high-quality stainless steel of implant
grade. This stainless-steel alloy has a low sulphur content,
and molybdenum is added to increase its hardness and
resistance to corrosion [10]. The composition specifica-
tion requirement of AISI 316L is illustrated in table 4.
This composition is designed to decrease the risk of nickel
ion release [10]. Indeed, the calculated rate of nickel
release in our study was !0.05 Ìg/cm2/week which is
actually undetectable by ICP-OES. As the nickel content
of the posts submitted to the present study was 11.5–
12.9% per total mass, this finding is quite remarkable. In

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 Table 4. Typical AISI material composition requirements for classification as 316L stainless steel
C Si Mn
0.03% max. 1% max. 2% max.
an earlier study on nickel release from AISI 316L ear
piercing post assemblies, the Ear Piercing Manufacturers
of Europe reported a mean calculated nickel release of
0.12 Ìg/cm2/week (viewed unpublished report sponsored
by the Ear Piercing Manufacturers of Europe where 40
AISI 316L ear piercing post assemblies were tested for
nickel release and content). These results were higher than
the very low nickel release encountered in the present
study. By comparison, the rate of calculated nickel elution
from the 10 unused post assemblies received before the
study and stored at our department was recorded between
0.11 and 0.21 (mean: 0.15) Ìg/cm2/week (table 3). The
question that needed to be answered is: why did the ear
piercing post assemblies used in the study release less
nickel than the ones that were not used? One likely answer
is that after manufacture of the ear piercing post assem-
blies, free nickel ions or a labile compartment of nickel
could be trapped on the surface of the ear piercing post
assemblies and released after being placed in an erosive
environment such as the ear. Once the free nickel ions had
been released, there was less nickel left to be released dur-
ing the nickel release test conducted after the piercing
period, hence the low results. In the case of the ear pierc-
ing post assemblies tested for nickel release without un-
dergoing a 6-week period in the ear lobe, the free nickel
ions were still available for release during the nickel
release test, hence the higher results. This hypothesis is
supported by the study of Flint and Packirisamy [15] on
nickel release rates after the first use of stainless-steel
cooking utensils. These authors have suggested that free
nickel ions trapped in the finishing phase of the manufac-
turing process may be released during the first use of the
cooking utensil, accounting for a lower nickel release upon
subsequent usage.
All subjects participating in the present study had a
documented history of nickel sensitivity and positive
patch test reactions to nickel. None of the subjects showed
evidence of contact dermatitis during the 6 weeks of the
study. These findings appear to indicate that the AISI
316L stainless-steel ear piercing post assembly does not
elicit contact dermatitis in nickel-sensitive patients and is
even less likely to sensitize subjects without prior nickel
AISI 316L Stainless-Steel Ear Piercing and
Nickel Sensitivity
P S Ni Cr Mo Fe
0.45% max. 0.03% max. 10–14% 16–18% 2–3% balance
sensitivity despite the very low levels of nickel ions that
may have been trapped on the finish and then released
from the ear piercing post assemblies upon first usage. It is
interesting to note that 7 subjects had hand eczema and 5
of them showed hypersensitivity to nickel only (No. 1, 3,
4, 6, 8). These findings indicate that nickel may cause
hand eczema as the only symptom of sensitivity.
We are aware of the small number of tested subjects
but we were limited by strict rules for patient recruitment.
As such, we recruited patients whose medical records
indicated that they had been nickel-sensitive patients for
several years and whose condition had been previously
diagnosed by the study coordinators, all of whom were
experienced dermatologists. All the subjects had positive
reactions to nickel after patch testing prior to the study.
None of the subjects had been able to wear nickel-releas-
ing earrings for many years prior to the study. Although
the numbers of strong responses to nickel after patch tests
were low, and a lack of positive controls and blind read-
ings, we are certain, beyond any doubt, that all subjects
who participated in the study were nickel-sensitive pa-
tients.
The current European Nickel Directive limits the nick-
el content of piercing post assemblies and forbids the use
of nickel-containing material in ear piercing applications.
Although measures implemented for protecting consum-
ers by limiting direct exposure to nickel are fully justified,
the present study indicates that a nickel release limit
would be a more appropriate protective regulation than
any arbitrary number related to the nickel content of
piercing post assemblies. This would allow the use of non-
sensitizing nickel-containing alloys such as the one used
in the present study. A further benefit of the use of such
materials would be the ability of consumers affected by
gold, palladium and other metal sensitizations to use low-
nickel-releasing materials such as the AISI 316L stainless
steel in ear piercing. Applying a maximum allowable nick-
el release regime on ear piercing post assemblies seems to
be further substantiated by a recent study from Denmark
[16] which showed a marked decrease in the rate of nickel
allergies in young children whose ears were pierced after
the introduction of the Danish regulation which limited
Exog Dermatol 2003;2:195–200 199
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nickel release in consumer products including piercing
post assemblies to 0.5 Ìg/cm2/week. Though this particu-
lar study was limited to the use of high-grade stainless-
steel post assemblies as applied to ear piercing, a question
may be asked as to whether the same result would occur
when using similar material to pierce other parts of the
body as this practice has seen a marked increase in recent
times, especially amongst the adolescent culture [17].
Though no express study has been conducted in analysing
the nickel release from stainless-steel post assemblies used
to pierce areas of the body other than the ear, the authors
believe that there is sufficient evidence from the informa-
tion gathered in the current study which can be readily
applied to situations where other areas of the body are
pierced. That is to say, given that allergic nickel contact
dermatitis is caused by the bio-availability of nickel ions
or salts entering the body at above minimum threshold
levels [6], all jewellery used in the manufacture of body
piercing post assemblies should also observe a low nickel
release requirement. With the levels of nickel released
from the AISI 316L stainless steel used in the current
study being below accurate detection levels, this would
infer that similar material could also be utilized safely in
the production of jewellery designed to pierce other areas
of the body. If a maximum nickel release requirement
were to be enforced, only materials meeting this require-
ment could be used in the production of all piercing post
assemblies regardless of the area of the body pierced, thus
limiting the exposure of nickel bio-availability to consum-
ers through this application.
Acknowledgements
The Ear Piercing Manufacturers of Europe Ltd. (UK), Spalding,
UK, a trade association, provided the ear piercing post assemblies
and financial support to cover the cost of the present study. The ear
piercing post assemblies utilized in the study were manufactured by
Studex Corporation.
Appendix 1
Description of the ICP-OES and Operating Protocol
Analytical procedures are carried out to the requirements of BS
EN ISO/IEC 17025 as administered by UKAS.
The inductively coupled plasma emission spectrometer has the
following characteristics:
– simultaneous measurement of nickel emission lines, 231.003 and
341.476 nm;
– a detection limit for nickel of better than 0.01 mg/l;
– the standard deviation of 10 measurements of the absorption of a
full matrix solution containing 0.05 mg nickel per litre of better
than 10%;
– a means of measuring the off peak position to correct for the stan-
dards and sample background.
The ICP-OES operating protocol is as follows:
– establish a baseline for the instrument using deionized water;
– analyse a preparation blank;
– analyse certified reference materials to produce an instrument
calibration;
– install the calibration in the instrument;
– analyse samples and independent control solutions, these control
solutions being interspersed with the samples;
– statistically review results from control solutions to ensure com-
pliance with the specified analytical parameters; results that are
outside specified parameters would lead to a repetition of the
analysis;
– results from each sample are recorded, assessed, converted into
percentages and reported.

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