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Does the New Standard for Eugenol Designed to Protect Against Contact Sensitization Protect Those Sensitized From Elicitation of the Reaction?

Svedman, Cecilia LU ; Engfeldt, Malin LU ; Api, Anne Marie; Politano, Valerie T.; Belsito, Donald V.; Gruvberger, Birgitta LU and Bruze, Magnus LU (2012) In Dermatitis 23(1). p.32-38
Abstract
Background:

Potential fragrance allergens used in daily products should have a concentration limited to levels that are at, or below, acceptable exposure levels based on the quantitative risk assessment for the induction of dermal sensitization. To date, there are insufficient data to discern any quantitative relationship between induction and elicitation concentrations for fragrance ingredients that have a potential for dermal sensitization. When available, these data should be used to confirm the effectiveness of quantitative risk assessment-based risk management procedures.



Objective:

In this study, the relationship between the allergen concentration and the time to elicit allergic contact... (More)
Background:

Potential fragrance allergens used in daily products should have a concentration limited to levels that are at, or below, acceptable exposure levels based on the quantitative risk assessment for the induction of dermal sensitization. To date, there are insufficient data to discern any quantitative relationship between induction and elicitation concentrations for fragrance ingredients that have a potential for dermal sensitization. When available, these data should be used to confirm the effectiveness of quantitative risk assessment-based risk management procedures.



Objective:

In this study, the relationship between the allergen concentration and the time to elicit allergic contact dermatitis in eugenol-sensitized patients was studied. The products used to elicit allergic contact dermatitis had a concentration of eugenol that was equal to, or below, the International Fragrance Association standard.



Methods:

Volunteers with and without known sensitization to eugenol were patch tested with various concentrations of eugenol (dilution series) and also underwent repeated open application tests (ROATs). This study model has previously been successfully used with stronger sensitizers.



Results:

In this study, allergic contact dermatitis, as evidenced by a positive ROAT, could not be elicited by any of the concentrations studied, including in those patients where the patch tests were positive.



Conclusions:

When tested in a 3-week ROAT at, or below, its current International Fragrance Association Standard, eugenol did not induce reactions even in those known to be sensitized. Whether this represents a false-negative result for a weak allergen is unknown. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Dermatitis
volume
23
issue
1
pages
32 - 38
publisher
BC Decker
external identifiers
  • wos:000300122000006
  • scopus:84865037157
ISSN
1532-8163
DOI
10.1097/DER.0b013e31823d17b8
language
English
LU publication?
yes
id
86faebdb-8941-4037-87b7-eddc344859ba (old id 2409663)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/22653067?dopt=Abstract
date added to LUP
2012-04-02 09:31:20
date last changed
2017-01-01 03:55:18
@article{86faebdb-8941-4037-87b7-eddc344859ba,
  abstract     = {Background: <br/><br>
Potential fragrance allergens used in daily products should have a concentration limited to levels that are at, or below, acceptable exposure levels based on the quantitative risk assessment for the induction of dermal sensitization. To date, there are insufficient data to discern any quantitative relationship between induction and elicitation concentrations for fragrance ingredients that have a potential for dermal sensitization. When available, these data should be used to confirm the effectiveness of quantitative risk assessment-based risk management procedures. <br/><br>
<br/><br>
Objective: <br/><br>
In this study, the relationship between the allergen concentration and the time to elicit allergic contact dermatitis in eugenol-sensitized patients was studied. The products used to elicit allergic contact dermatitis had a concentration of eugenol that was equal to, or below, the International Fragrance Association standard. <br/><br>
<br/><br>
Methods: <br/><br>
Volunteers with and without known sensitization to eugenol were patch tested with various concentrations of eugenol (dilution series) and also underwent repeated open application tests (ROATs). This study model has previously been successfully used with stronger sensitizers. <br/><br>
<br/><br>
Results: <br/><br>
In this study, allergic contact dermatitis, as evidenced by a positive ROAT, could not be elicited by any of the concentrations studied, including in those patients where the patch tests were positive. <br/><br>
<br/><br>
Conclusions: <br/><br>
When tested in a 3-week ROAT at, or below, its current International Fragrance Association Standard, eugenol did not induce reactions even in those known to be sensitized. Whether this represents a false-negative result for a weak allergen is unknown.},
  author       = {Svedman, Cecilia and Engfeldt, Malin and Api, Anne Marie and Politano, Valerie T. and Belsito, Donald V. and Gruvberger, Birgitta and Bruze, Magnus},
  issn         = {1532-8163},
  language     = {eng},
  number       = {1},
  pages        = {32--38},
  publisher    = {BC Decker},
  series       = {Dermatitis},
  title        = {Does the New Standard for Eugenol Designed to Protect Against Contact Sensitization Protect Those Sensitized From Elicitation of the Reaction?},
  url          = {http://dx.doi.org/10.1097/DER.0b013e31823d17b8},
  volume       = {23},
  year         = {2012},
}