Quaternium-15 is a quaternary ammonium salt. It is most commonly used as part of what is usually a large "cocktail" of preservatives in personal and skin care products that require a long shelf life. It is a known formaldehyde donor. . It can cause contact dermatitis, a symptom of an allergic reaction, especially in those with sensitive skin, on an infant's skin, or on sensitive areas such as the genitals.

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Four common formaldehyde releasers to
avoid in your cosmetics and skin care
By: Dr. Mohammad Baghaei
Quaternium-15
Quaternium-15 is a quaternary ammonium salt. It is most commonly used as part of
what is usually a large "cocktail" of preservatives in personal and skin care products that
require a long shelf life. It is a known formaldehyde donor. . It can cause contact
dermatitis, a symptom of an allergic reaction, especially in those with sensitive skin, on
an infant's skin, or on sensitive areas such as the genitals.
The compound has even been identified by the EU (European Union) as an ingredient
that may not be safe in cosmetics and therefore, its use has been limited. It is also used
in latex paints, industrial types of adhesives and other home consumer products.
Quaternium-15 has also been identified as a potential immune irritant as allergic
responses have been reported.
Learn more:

Contact Dermatitis. 2010 Oct;63(4):187-91. doi: 10.1111/j.16000536.2010.01712.x.
Relationship between formaldehyde and quaternium-15 contact allergy. Influence
of strength of patch test reactions.
de Groot AC, Blok J, Coenraads PJ.
Abstract
BACKGROUND:
In groups of patients with formaldehyde allergy, many have positive patch tests to
quaternium-15. Conversely, of patients allergic to quaternium-15, over half also react to
formaldehyde.
By : Dr. Mohammad Baghaei
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OBJECTIVES:
To test our hypothesis that patients with stronger patch test reactions to formaldehyde
are more likely to react to quaternium-15, attesting to the aetiological role for
formaldehyde in such co-reactivity.
METHODS:
Retrospective analysis of all patients patch tested with formaldehyde and quaternium-15
in the European baseline series between 1994 and 2009 (TRUE test).
RESULTS:
In a group of 86 patients allergic to formaldehyde, 73% co-reacted to quaternium-15; in
the subgroup of 70 women, the percentage was 83. In both groups, more reactions
were observed to quaternium-15 in the patients with a ++ reaction compared to the
patients with a + reaction to formaldehyde. Conversely, stronger reactions to
quaternium-15 were significantly more often associated with formaldehyde sensitivity in
a group of 107 patients reacting to quaternium-15 and a subgroup of 88 women. In
men, such effects were not observed and only 5 of 16 (31%) men allergic to
formaldehyde also reacted to quaternium-15.
CONCLUSIONS:
In women, but not in men, stronger reactions to formaldehyde lead to more positive
quaternium-15 patch tests.
© 2010 John Wiley & Sons A/S.
PMID:20573164
[PubMed - indexed for MEDLINE]

Dermatitis. 2012 Jan-Feb;23(1):39-43. doi: 10.1097/DER.0b013e31823d1785.
Is quaternium-15 a formaldehyde releaser? Correlation between positive patch
test reactions to formaldehyde and quaternium-15.
Odhav A, Belsito DV.
Abstract
BACKGROUND:
The question of whether quaternium-15 is a formaldehyde releaser is controversial.
Understanding this relationship is critical because of the widespread use of quaternium15 and the need to properly advise formaldehyde-allergic individuals.
OBJECTIVES:
This study aimed to look for an association between allergy to quaternium-15 and
formaldehyde by correlating reactions to both and to correlate the intensity of positive
patch test results to formaldehyde with reactivity to quaternium-15.
METHODS:
This is a retrospective analysis of 1905 patients who underwent patch testing for allergic
contact dermatitis. Associations were analyzed by χ testing.
RESULTS:
Of all patients, 9.5% reacted to quaternium-15, 7.2% reacted to formaldehyde, and
5.4% reacted to both (P < 0.001). Of 137, 86 had strong (2 or 3+) and 51 had weak (1+
or +/-) formaldehyde reactions; there was no relationship between the severity of
formaldehyde reactivity and responsiveness to quaternium-15 (P = 0.229). Sex analysis
did not change these findings.
By : Dr. Mohammad Baghaei
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LIMITATIONS:
This study is limited by its retrospective analysis and small sample size.
CONCLUSIONS:
A statistically significant relationship exists between reactivity to quaternium-15 and
formaldehyde; however, the severity of the formaldehyde reaction does not predict
reactivity to quaternium-15. Despite coreactivity with formaldehyde, quaternium-15 may
not be a significant formaldehyde releaser. The coreactivity between quaternium-15 and
formaldehyde requires further studies.
PMID: 22653068
[PubMed - indexed for MEDLINE]
DMDM Hydantoin
DMDM hydantoin is an antimicrobial formaldehyde releaser preservative with the trade
name Glydant. DMDM hydantoin is an organic compound belonging to a class of
compounds known as hydantoins. It is used in the cosmetics industry and found in
products like shampoos, hair conditioners, hair gels and skin care products.
This ingredient is restricted for use in cosmetics in Japan due to safety concerns.
There are concerns that it may cause tissue irritation and also may interfere with
immunity. This may likely be due to the fact that it begins to release formaldehyde over
the life of whatever product it is present in since these are both health concerns
attributed to formaldehyde.
Learn more:
 Dermatitis. 2007 Sep;18(3):155-62.
Sensitivity of petrolatum and aqueous vehicles for detecting allergy to
imidazolidinylurea, diazolidinylurea, and DMDM hydantoin: a retrospective
analysis from the North American Contact Dermatitis Group.
By : Dr. Mohammad Baghaei
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Rietschel RL, Warshaw EM, Sasseville D, Fowler JF Jr, DeLeo VA, Belsito DV, Taylor
JS, Storrs FJ, Mathias CG, Maibach HI, Marks JG Jr, Zug KA, Pratt M; North American
Contact Dermatitis Group.
Abstract
OBJECTIVE:
To determine whether petrolatum or aqueous vehicles are more sensitive for detecting
allergy to imidazolidinylurea (IU), diazolidinylurea (DU), and dimethylol dimethyl
hydantoin (DM). The relationship of these allergens to formaldehyde sensitivity was also
explored.
METHODS:
Retrospective analysis of patients patch-tested by the North American Contact
Dermatitis Group. All patients were simultaneously tested to seven allergens
(formaldehyde, IU in petrolatum [pet], IU aqueous [aq], DU pet, DU aq, DM pet, and DM
aq). Data were analyzed in pairs with various "gold standard" definitions of "true allergy"
and adjusting for correlated data.
RESULTS:
Reaction to at least one of the seven allergens occurred in 2,398 patients. In all cases
except one (which just approached statistical significance), the petrolatum-based
allergen was statistically significantly more sensitive than the same allergen in an
aqueous base. Most of the patients allergic to the three preservatives were also allergic
to formaldehyde, but most formaldehyde-allergic patients were not allergic to the IU,
DU, or DM.
CONCLUSION:
Of these two vehicles, petrolatum is significantly more sensitive than an aqueous
vehicle is for detecting allergy to IU, DU, and DM.
PMID: 17725923[PubMed - indexed for MEDLINE]

Contact Dermatitis. 1988 Apr;18(4):197-201.
Patch test reactivity to DMDM hydantoin. Relationship to formaldehyde allergy.
de Groot AC, van Joost T, Bos JD, van der Meeren HL, Weyland JW.
Abstract
The relationship between contact allergy to formaldehyde and positive patch test
reactions to DMDM hydantoin was investigated. 35 formaldehyde-allergic patients were
patch tested with serial dilutions of formaldehyde (0.1%-0.3%-1.0% aq.) and DM
hydantoin (the non-formaldehyde-containing parent compound of DMDM hydantoin). 21
were also patch tested with MDM hydantoin (1 molecule formaldehyde) in serial
dilutions: 7 (33%) reacted to 1 or more concentrations. The other 14 were also tested
with DMDM hydantoin (2 molecules formaldehyde) in serial dilutions: 8 (57%) reacted to
1 or more concentrations. Patients patch-test-positive to formaldehyde 0.1% and/or
0.3% tended to show more patch test reactivity to (D)MDM hydantoin than those who
reacted only to 1%. Aqueous solutions of (D)MDM hydantoin in concentrations as used
By : Dr. Mohammad Baghaei
www. facedoux.com

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in cosmetic products therefore contain enough free formaldehyde to cause dermatitis in
a patch test system in some formaldehyde-allergic patients: 12 such patients applied a
cream containing 1% DMDM hydantoin to the flexor aspect of the lower arm twice daily
for 1 week; 4 (33%) developed dermatitis. The use of a cream containing 0.25% DMDM
hydantoin in these 4 patients still caused dermatitis in 1 and provoked itching in another.
An increase in the use of DMDM hydantoin in cosmetic products will also inevitable
increase the risk of cosmetic dermatitis in consumers allergic to formaldehyde.
PMID: 3378426
[PubMed - indexed for MEDLINE]
Ureas
Diazolidinyl urea is an antimicrobial preservative used in cosmetics. It is chemically
related to imidazolidinyl urea which is used in the same way. Diazolidinyl urea acts as a
formaldehyde releaser.It is used in many cosmetics, skin care products, shampoos and
conditioners, as well as a wide range of products including bubble baths, baby wipes
and household detergents. Diazolidinyl urea is found in the commercially available
preservative Germaben.
Commercial diazolidinyl urea is a mixture of different formaldehyde addition products
including polymers.
Learn more:

Contact Dermatitis. 1988 Apr;18(4):202-5.
Contact allergy to diazolidinyl urea (Germall II).
de Groot AC, Bruynzeel DP, Jagtman BA, Weyland JW.
Abstract
4 cases of contact allergy to diazolidinyl urea (Germall II) in a "hypoallergenic" brand of
cosmetics are described. 2 patients sensitized by these cosmetics were not allergic to
By : Dr. Mohammad Baghaei
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formaldehyde. 2 other patients already sensitive to formaldehyde had exacerbations of
dermatitis due to diazolidinyl urea. The following tentative conclusions were drawn. (i)
Contact allergy to diazolidinyl urea may or may not be due to formaldehyde sensitivity.
(ii) Patients allergic to formaldehyde may suffer contact allergic reactions from the use
of cosmetics containing diazolidinyl urea. (iii) Patients sensitized to diazolidinyl urea
may cross-react to imidazolidinyl urea and vice-versa. (iv) It is suggested that the
sensitizing potential of diazolidinyl urea is greater than that of imidazolidinyl urea. (v)
Aq. solutions may be preferable to pet. for patch testing with diazolidinyl urea.
PMID: 3378427[PubMed - indexed for MEDLINE]
 Contact Dermatitis. 2005 Nov;53(5):268-77.
Experimental elicitation of contact allergy from a diazolidinyl urea-preserved
cream in relation to anatomical region, exposure time and concentration.
Zachariae C, Hall B, Cottin M, Cupferman S, Andersen KE, Menné T.
Abstract
The elicitation potential of the cosmetic preservative diazolidinyl urea was studied in
formaldehyde- and diazolidinyl urea-sensitized volunteer patients using a stepwise
controlled exposure design. The test product was a facial moisturizer, preserved with
varying concentrations of diazolidinyl urea, ranging from 0.05% to 0.6%. A repeated
open application-like exposure test was performed on volunteers and a control group
with the test product containing increasing preservative concentrations, on arm, neck
and face, sequentially, for 2 weeks or until dermatitis developed. The preservative
action in the cream at different test concentrations was tested in microbial challenge
tests and was found effective at all concentrations tested. The study established a noneliciting concentration of diazolidinyl urea of 0.05% in formaldehyde-sensitive patients
and showed that the skin reactivity depends on the anatomical region, increasing from
the upper arm to neck and, possibly, to the face. The study design, beginning on the
upper arm and moving on to the neck and face seems to be relevant for the study of
reactions to cosmetic products. A clear dose-response relationship was seen regarding
preservative concentration in the product.
PMID:
16283905
[PubMed - indexed for MEDLINE]
Sodium Hydroxymethylglycinate
This is commonly used not only as a preservative, but also as an additive to hair care
products for straightening or softening effects. It has been identified as a potential
allergen.
It is actually considered to be one of the lowest of the donors since it does not tend to
release as much formaldehyde as those discussed previously. This ingredient can also
By : Dr. Mohammad Baghaei
www. facedoux.com

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be listed as any of the following: Glycine, N- (Hydroxymethyl) - Monosodium Salt;
Glycine, N- (Hydroxymethyl) -, Sodium Salt; N-(Hydeoxymethyl) Glycine, Sodium Salt.

Dermatitis. 2010 Mar-Apr;21(2):109-10.
Sodium hydroxymethylglycinate.
Russell K, Jacob SE.
Abstract
Sodium hydroxymethylglycinate (SHMG) is a preservative used in many commercially
available products, including shampoos, conditioners, soaps, moisturizers, body sprays,
baby wipes, room sprays, cleaning agents, and pesticides. It is in a class of chemicals
known as formaldehyde-releasing preservatives. Notably, members of this class have
been associated with allergic contact dermatitis, possibly due to the agents themselves,
the formaldehyde they release, or both. Studies on SHMG in animals have
demonstrated potential for sensitization and dermatitis, and formaldehyde-allergic
patients have been reported to improve when products containing SHMG are avoided.
Patients and providers need to be aware of this preservative.
PMID:
20233550
[PubMed - indexed for MEDLINE]
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