Search to the right to find information on the ingredient you are looking for >>>
Morpholine is a clear, oily liquid. In cosmetics and personal care products, Morpholine may be used in the formulation of eyeliner, eye shadow, mascara, eye makeup remover and skin care products.
Morpholine functions as a pH adjustor. It may also function as a surfactant and emulsifier.
Morpholine is a heterocyclic secondary amine. In addition to its use in cosmetics and personal care products, Morpholine derivatives have been used as insecticides, fungicides, herbicides, anesthetics, analgesics, and antiseptics.
The Food and Drug Administration (FDA) includes Morpholine on its list of direct food additives. It is permiteed in coatings, films and related substances. Morpholine is also an FDA approved indirect food additive that may be used as a component of adhesives and paper and paperboard. The safety of Morpholine has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that the data were insufficient to support the safety of this ingredient as used in cosmetics and personal care products.
CIR Safety Review: The CIR Expert Panel noted that Morpholine that has not been neutralized (hydrogen bound to the nitrogen) was more irritating than Morpholine that has been neutralized (hydrogen bound to nitrogen replaced, for example with chloride). In short-term inhalation studies with varying concentrations of Morpholine, the effects observed included irritation of the mucous membranes and an increased respiratory rate. Chronic inhalation studies of Morpholine reported changes in the nervous system activity and arterial and peripheral blood pressure. At the high concentrations, Morpholine produced swelling of the alveolar cells and atrophy of lymphoid elements in the spleen. At lower concentrations, a decrease in the size of the lymph nodules in the spleen was noted. Morpholine was a weak positive mutagen in L5178 lymphoma assay, in BALB/3T3 malignant cell transformation, and fibroblast transformation assays, and in sister chromatid exchange assays, but was negative in bacteria with and without metabolic activation. At nontoxic doses, Morpholine did not increase the rate of DNA repair in hepatocytes. Results of other mutagenic assays varied with the system used. In humans, Morpholine was absorbed and was considered to be a skin and eye irritant, as well as a skin sensitizer.
A formulation containing 1% Morpholine indicated that the ingredient was neither an irritant nor sensitizer. The CIR Expert Panel acknowledged that cosmetics and personal care products containing Morpholine, in the presence of nitrate or other nitrosating agents, may give rise to N-nitrosomorpholine. N-nitrosomorpholine was mutagenic in a variety of test systems and simulataneous exposure to Morpholine and nitrites has caused a number of different cancers. A carcinogenic response was produced in a long-term feeding study of Morpholine in which nitrates were present in the diet. Because of the concern about potential nitrosamine formation and the lack of information on whether or not nitrosamines are present when Morpholine was used as a cosmetic ingredient, the CIR Expert Panel concluded that the data were insufficient to support the safety of Morpholine as used in cosmetics and personal care products.
More information about nitrosamines.
Link to FDA Code of Federal Regulations for Morpholine
Health Canada prohibits the use of Morpholine and its salts in cosmetics and personal care products. http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri...
Morpholine and its salts are listed in the Cosmetics Directive of the European Union (see Annex II) and must not form part of the composition of cosmetics and personal care products.
Link to the EU Cosmetic Regulation:http://europa.eu/legislation_summaries/consumers/product_labelling_and_p...
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul...
Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
2016 Copyright. All Rights Reserved. Cosmeticsinfo.org