摘要
Background: The rapidly increasing level of contact allergy to methyldibromog lutaronitrile (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 determi ne whether 50 p.p.m. or 100 p.p.m. could be tolerated by MDBGN-sensitized indi viduals, 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 volunteerswith contact allergy to MDBGN and 10 healthy controls were exposed to repeated open application tests (ROATs) with t wo moisturizers with a high and a low lipid content, respectively, both containi ng MDBGN at a concentration of 50 p.p.m. The ROATs were performed on the left an d the right side of the neck for 14 days, or until a positive re action was seen. If a positive reaction did not develop within the first 14 d ays, two analogous moisturizers containing 100 p.p.m. MDBGN were applied for a f urther 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 der matitis 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 th e 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 con centration for use and the prohibition of MDBGN is scientifically well founded.
Background: The rapidly increasing level of contact allergy to methyldibromog lutaronitrile (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 determi ne whether 50 p.p.m. or 100 p.p.m. could be tolerated by MDBGN-sensitized indi viduals, 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 volunteerswith contact allergy to MDBGN and 10 healthy controls were exposed to repeated open application tests (ROATs) with t wo moisturizers with a high and a low lipid content, respectively, both containi ng MDBGN at a concentration of 50 p.p.m. The ROATs were performed on the left an d the right side of the neck for 14 days, or until a positive re action was seen. If a positive reaction did not develop within the first 14 d ays, two analogous moisturizers containing 100 p.p.m. MDBGN were applied for a f urther 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 der matitis 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 th e 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 con centration for use and the prohibition of MDBGN is scientifically well founded.
