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Contact Dermatitis. 1997, 36, 121-123 Printed in Denmark. All rights reserved Copyright C Munksgaard 1997 CONTACT DERMATITIS ISSN 0105-1873
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Review Article
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Proposal for a revised international standard series of patch tests
J.-M. LACHAPELLE1, S.I. ALE2, S. FREEMA3, N P.J. FROscH4, C.L. GOH5, M. HANNUKSELA6,
R. HAYAKAWA7, H. I. MAIBACH8 AND J.E. WAHLBERG9
The International Contact Dermatitis Research Group
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1Unit for Occupational Dermatology UCL 3033, 30 Clos Chapelle-aux-Champs, B- 1200 Bruxelles,Belgium
2Department of Dermatology, Hospital de Clinicas Dr. Manuel Quintela, Montevideo, Uruguay
3Skin and Cancer Foundation, Contact and Occupational Clinic, 277 Bourke Street, Darlinghurst, 2010 Sydney, Australia
4Hautklinik des Stadtischen Kliniken, Beurhausstrasse 40, D-44123 Dortmung, Germany
5National Skin Center, 1 Mandalay Road, Singapore 1130
6South Karelia Central Hospital, Valto Kakelan katu 14A, FlN-53130 Lappeenranta, Finland
7Division of Dermatology, Nagoya University Branch Hospital, 1-1-20, Daikominami, Higashiku, Nagoya 461 , Japan
8Department of Dermatology, University of California, School of Medicine, Box 0989, Surge 110, San Francisco, California 94143-0989, USA
9Department of Occupational Dermatology, Karolinska Hospital, S-I0401 Stockholm, Sweden
Worldwide, there are 3 major standard series of patch
tests, the European, North American and Japanese, together presenting 32
allergens, the differences between them being the result of regional
variation in allergen distribution as well as differences in dermatological
opinion. We propose a minimal international standard series of 20 allergens,
together with an extended international standard series of 14 allergens.
Key words: patch testing technique; standard series. C Munksgaard, 1997.
Accepted for publication 23 November 1996
There is no unanimity worldwide as
regards the contents of a standard series (1, 2). There are 3 major options
in building a standard series, in relation to potential regional variations
(3).
1 . The revised European standard series, as re-commended by the European
Environmental and Contact Dermatitis Research Group (EECDRG) (4), in I 994
(21 allergens+primin, optional).
2. The North American standard series (5, 6) ac-cording to the North
American Contact Dermatitis Group (20 allergens).
3. The Japanese standard series according to the Japanese Society for
Contact Dermatitis (25 allergens).
A comparison of the 3 lists (Table
1) suggests that 32 allergens are potentially considered in the
international standardization process. Note that neomycin sulfate in lists
(a) and (b) is synonymous with fradiomycin sulfate in list (c).
The discrepancies in comparing lists (a), (b), and (c) are due to 2 main factors:
1. There are regional variations, related either to the natural occurrence
of allergens (e.g., urushiol) or to significant variability in the use of
some allergens in various regions, due to different medical, cosmetical, industrial or environmental habits.
2. A different approach of the 3 research groups regarding each individual
allergen, thus reaching dissimilar conclusions. The 3 groups are working
independently, and have not con- fronted their opinions to reach a worldwide consensus.
Most decisions reached by each group are partly based upon
multicentre studies and/or thorough literature reviews (3).
Considering the current status of the standard series throughout the
world, the members of the International Contact Dermatitis Research Group (ICDRG)
discussed the possibility of using a shortened list of common allergens,
that could be used internationally as a minimal international standard
series. The following allergens have been considered eligible candidates for such a list (Table 2).
Some allergens present in 1 (or more) of the 3 lists of Table 1 are
not considered eligible candidates for the revised international standard
series presented in Table 2. On the other hand, they are listed in an
extended series (Table 3). Other allergens are also proposed in the extended series, since they
are considered useful in the literature.
Some of the allergens recorded in Table 1 lack general interest, for
different reasons. Therefore, they are not proposed as candidates for an ex
tended international series. Nevertheless they could be used in specific
circumstances. These allergens, dispersed in petrolatum, are: N-isopro-
pyl-N'-phenylparaphenylenediamine (IPPD) 0.1%; cinnamic aldehyde 1%; carba
mix 3% (often lacks clinical relevance); black rubber (PPD) mix 0.6%; caine
mix 7%; dithiocarbamate mix 2%; ammoniated mercuric chloride 1%.
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Table 1. Comparative lists of allergens in 3 different standard series
| Compound |
EECDRGa)
% |
NACDGb)
% |
JCDSc)
% |
| 1. potassium dichromate |
0.5 |
0.25 |
0.5
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2. neomycin sulfate
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20
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20
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3. thiuram mix
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1
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1
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1.25
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4.p-phenylenediamme base
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1
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1
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1
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5. cobalt chloride (CoCl2 6H20)
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1
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-
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1
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6. benzocaine
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5
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5
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7. formaldehyde
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1 (aq.)
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1 (aq.)
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1 (aq.)
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8. colophony
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20
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20
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20(rosin)
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9. clioquinol
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5
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-
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-
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10. balsam of Peru
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25
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25
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25
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11. N-isopropyl-N-phenyl paraphenylenediamine (IPPD)
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0.1
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12. wool (lanolin) alcohols
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30
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30
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30
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13. mercapto mix
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2
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1
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2
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14. epoxy resin
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1
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1
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1
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15. paraben mix
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16
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15
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16. p-tert-butylphenol-formaldehyde (BPF) resin
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1
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1
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1
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17. fragrance mix
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8
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8
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18. Quaternium 15
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1
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2
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19. nickel sulfate (NiS04･6H20)
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5
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2.5
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2.5
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20. Cl+Me-isothiazolinone
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0.01 (aq.)
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0.01 (aq.)
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21. mercaptobenzothiazole (MBT)
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2
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1
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22. primin
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0.01
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0.01
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23. imidazolidinyl urea
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2 (aq.)
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24. cinnamic aldehyde
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1
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25. carba mix
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3
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26. ethylenediamine dihydrochloride
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1
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1
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27. black rubber (PPD)
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0.6
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0.6
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28. fradiomycin sulfate
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20
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29. caine mix
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7
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30. dithiocarbamate mix
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2
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31. urushiol
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0.002
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32. thimerosal (thiomersal)
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0.1
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33. ammoniated mercuric chloride
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1
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34. petrolatum
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(as is)
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a) The revised European standard series as recommended by the
EECDRG, 1994. The concentrations quoted refer to petrolatum except where
otherwise stated.
b) North American standard series according to the North American Contact
Dermatitis Research Group. The concentrations quoted refer to petrolatum
except where otherwise stated.
c) The Japanese standard series according to the Japanese Society for
Contact Dermatitis. The concentrations quoted refer to petrolatum except
where otherwise stated.
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Top
Table 2. Proposed allergens for a modified international standard series:
the concentrations quoted refer to petrolatum except where otherwise stated.
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%
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1. potassium dichromate
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0.5
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2. neomycin sulfate
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20
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3. thiuram mixa)
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1
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4. p-phenylenediamine base (PPD)b)
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1
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5. Formaldehyde
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1(aq.)
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6. Colophony
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20
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7. balsam of Peru
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25
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8. wool (lanolin) alcohols
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30
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9. mercapto mixc)
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1
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10. epoxy resin
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1
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11. p-tert-butylphenol-formaldehyde (BPF) resin
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1
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12. fragrance mixd)
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8
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13. nickel sulfate (NiS04・6H20)
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2.5
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14. mercaptobenzothiazole (MBT)e)
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1
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15. Budesonidef)
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0.1
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16. quaternium 15g)
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2
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17. Cl+Me-isothiazolinoneh)
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0.01(aq.)
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18. imidazolidinyl urea 2
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2(aq.)
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19. tixocortol pivalate
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1
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20. Dibromodicyanobutanei)
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0.1
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a) Thiuram mix lacks high specificity and sensitivity.
b) Some cases of hair dye dermatitis could be missed with the use of PPD
alone.
c) Mercapto mix lacks high specificity and sensitivity. The 1% mix, used in
the North American standard series, is chosen since its stability has been
proven by Hermal and approved by the FDA (7).
d) If positive, breakdown is needed.
e) MBT can identify cases of allergic contact dermatitis negative to
mercapto mix, and vice versa.
f) Despite its absence in the 3 standard series, budesonide is highly
recommended in an international standard series, since it is considered an
important marker for corticosteroid allergy (8).
g) It is an important allergen in the United Kingdom, while it is not used
in Japan.
h) Mainly used in Japan.
i) Syn: 1,2-dibrom0-2,4-dicyanobutane; methyldibromoglutaronitrile. Present
in Euxyl K 400R (dibromodicyanobutane+ phenoxyethanol 1:4).
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Top
Table 3. Proposed allergens for an extended international standard series:
the concentrations quoted refer to petrolatum except where otherwise stated
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(%)
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A. Allergens present in 1 (or more) of the 3 lists of Table 1
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1 . cobalt chloride (CoCl2･6H20)a)
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1
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2 . benzocaine
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5
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3. clioquinol
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5
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4. paraben mix
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16
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5. primin
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0.01
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6. ethylenediamine dihydrochloride
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1
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7. urushiol
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0.002
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8. thimerosal (thiomersal)
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0.1
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B. Additional useful allergens
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9. sesquiterpene lactone mix
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0.1
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10. hydrocortisone 17-butyrate
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1(alc.)
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11. 2,5 diazolidinylureab)
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2(aq.)
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12. cetylstearylalcohol
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20
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13. toluenesulphonamide formaldehyde resin
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10
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14. propylene glycol
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10(aq.)
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a) Cobalt is not traced as relevant in many cases. Petechial
reac tions should not be read as positive.
b) It is not used in Japan.
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Top
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References
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1 . Rietschel R L, Fowler J F Jr. Fisher's contact
dermatitis, 4th edition Baltrmore Williams and Wilkm 1995: 1-1117.
2 Rycroft R J G, Menn6 T, Frosch P J. (eds): Textbook of contact dermatitis,
2nd edition. Berlin: Springer-Verlag: 1995: 340.
3. Bruynzeel D P et al. The European standard series. Contact Dermatitis
1995: 33: 145-148.
4. Lachapelle J M. Dermato-allergology in Europe : evolution of the standard
series. Nouv Dermatol 1993: 12: 280-282.
5. Nethercott J R et al. Patch testing with a routine screening tray in
North America 1985-1989 (1). Frequency of response. Am J Contact Dermatitis
1991: 2: 122-129.
6. Holness D L et al. Concomitant positive patch test results with standard
screening tray in North America 1985-1989. Contact Dermatitis 1995: 32;
289-292.
7. Geier J, Gefeller O. Sensitivity of patch tests with rubber mixes :
results of the information network of departments of dermatology from 1990
to 1993. Am J Contact Derma- titis 1995: 5: 143-149.
8. Dooms-Goossens A et al. Corticosteroid contact allergy: an EECDRG
multicentre study. Contact Dermatitis 1996: 35: 40-44.
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Address:
J. -M. Lachapelle
Unit of Dermato-allergology and Dermato-immunology
Lauvain University
30 clos Chapelle-aux-Champs
UCL 3033
B-1200 Bruxelles
Belgium
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