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3817902 
Journal Article 
Final report on the safety assessment of Quaternium-22 
Andersen, FA 
1995 
Yes 
Journal of the American College of Toxicology
ISSN: 0730-0913 
14 
6 
485-497 
WOS:A1995TN20100009 
The quaternary ammonium salt Quaternium-22 is used as a film former, hair conditioning agent, and antistatic agent in a wide variety of cosmetic products. This ingredient has reportedly also been used as an emollient and skin conditioner. It is supplied in water with 60% solids (Quaternium-22). Impurities include 3-dimethylaminopropylamine (DMAPA) at concentrations up to 2.45%, and ethylene chlorohydrin (ECH) up to 0.097%. The maximum concentration of Quaternium-22 in formulations is 5.0%. An acute oral toxicity study in rats using 6% Quaternium-22 failed to kill any of the animals. Exposure to 0.5% Quaternium-22 was a slight irritant in a 28-day dermal toxicity study in rabbits; no other adverse reactions related to the test substance were found. Ocular exposure to 8.5% Quaternium-22 produced minimal conjunctival irritation, but 6% did not. Intracutaneous injections of 6% Quaternium-22 did not produce irritation or sensitization in Guinea pigs. No evidence of mutagenesis was seen in the Ames test. Clinical data revealed no irritation or sensitization, nor was there any evidence of photosensitization. While there was some concern over the toxicity of the DMAPA and ECH impurities, the absence of any toxicologic or mutagenic findings on exposure to material containing these impurities suggested there were no adverse effects associated with either the ingredient or any impurities. In order that exposure to these impurities be kept low, however, it was recommended that the concentration of this ingredient in cosmetic products should be limited so that the concentration of DMAPA not exceed 0.2% and that of ECH not exceed 0.008-this is consistent with the expected use of Quaternium-22 at less than or equal to 5% solids. Accordingly, it was concluded that the cosmetic ingredient Quaternium-22 is safe in the present practices of use. 
Quaternium-22; rat; guinea pig; 3-dimethylaminopropylamine; ethylene chlorohydrin