Document Detail

Methyldibromoglutaronitrile in leave-on products elicits contact allergy at low concentration.
MedLine Citation:
PMID:  15491422     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The rapidly increasing level of contact allergy to methyldibromoglutaronitrile (MDBGN) in Europe is of concern. In April 2003, the EU Commission prohibited the use of MDBGN in leave-on cosmetic products, such as creams and lotions, until a level of safe use can be defined. Industry risk assessment has indicated that such a safe level could be 50-100 p.p.m. OBJECTIVES: To determine whether 50 p.p.m. or 100 p.p.m. could be tolerated by MDBGN-sensitized individuals, and to evaluate if the risk for elicitation of MDBGN allergy is higher for a leave-on product with a high lipid content than for a product with a low lipid content. METHODS: Eighteen volunteers with contact allergy to MDBGN and 10 healthy controls were exposed to repeated open application tests (ROATs) with two moisturizers with a high and a low lipid content, respectively, both containing MDBGN at a concentration of 50 p.p.m. The ROATs were performed on the left and the right side of the neck for 14 days, or until a positive reaction was seen. If a positive reaction did not develop within the first 14 days, two analogous moisturizers containing 100 p.p.m. MDBGN were applied for a further 14 days. Clinical assessments were done on days 2, 3, 7, 14, 21 and 28 or when a reaction developed. RESULTS: Eleven of 18 (61%) subjects developed dermatitis on the test area, of whom 10 developed a positive reaction to the 50 p.p.m. moisturizer, seven having a positive reaction on day 2 or 3. Reactions to the low-lipid moisturizer were the more frequent. All participants used more of the low-lipid moisturizer than the high-lipid moisturizer. The controls all had negative ROATs. CONCLUSIONS: Even 50 p.p.m. cannot be regarded as a safe concentration for use and the prohibition of MDBGN is scientifically well founded.
L Kynemund Pedersen; T Agner; E Held; J D Johansen
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The British journal of dermatology     Volume:  151     ISSN:  0007-0963     ISO Abbreviation:  Br. J. Dermatol.     Publication Date:  2004 Oct 
Date Detail:
Created Date:  2004-10-19     Completed Date:  2005-02-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  817-22     Citation Subset:  IM    
National Allergy Research Centre for Consumer Products and Department of Dermatology, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
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MeSH Terms
Cosmetics / toxicity
Dermatitis, Allergic Contact / etiology*
Dose-Response Relationship, Drug
Emollients / toxicity
Lipids / analysis
Middle Aged
Nitriles / toxicity*
Patch Tests / methods
Preservatives, Pharmaceutical / toxicity
Risk Assessment / methods
Reg. No./Substance:
0/Cosmetics; 0/Emollients; 0/Lipids; 0/Nitriles; 0/Preservatives, Pharmaceutical; 35691-65-7/1,2-dibromo-2,4-dicyanobutane

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