Isostearamidopropyl Morpholine Lactate

The safety of Isostearamidopropyl Morpholine Lactate has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Isostearamidopropyl Morpholine Lactate was safe for use as a cosmetic ingredient in rinse-off formulations. The CIR Expert Panel also concluded that the available data were insufficient to determine the safety in leave-on formulations.

CIR Safety Review: Isostearamidopropyl Morpholine Lactate was nontoxic in acute oral toxicity studies. Although morpholine is considered a cutaneous, ocular, and mucous membraneA thin layer of animal or plant tissue that serves as a covering or lining for an organ or a part. irritant, and a sensitizer, Isostearamidopropyl Morpholine Lactate exhibited none of the sensitization and irritant reactions observed with morpholine. Isostearamidopropyl Morpholine Lactate was minimally irritating to eyes, and mildly irritating to intact and abraded skin. Although sensitization was not seen in clinical tests, some irritancy was noted.

Isostearamidopropyl Morpholine Lactate was not mutagenic in bacteria, with or without metabolic activation, although cellThe basic structural and functional unit of all organisms; cells may exist as independent units of life or may form colonies or tissues as in higher plants and animals. killing was seen at most test concentrations. Although Morpholine is readily nitrosated to form nitrosamines, N-nitroso impurities were not detected in Isostearamidopropyl Morpholine Lactate. Mutagenicity data on Isostearamidopropyl Morpholine Lactate in mammalian systems were not available, nor were data available on skin penetration or toxicity associated with inhalation exposures.

Accordingly, the safety of this ingredient in leave-on cosmetic formulations could not be determined. Based on the available data, this ingredient was considered safe for use in rinse-off cosmetic products. The CIREP concluded that additional data needed for assessing the safety of leave-on uses included: skin penetration; depending on the results, a 28-day dermal toxicity study and a reproductive and developmental study may be needed; one genotoxicity study in a mammalian system; if positive, a 2-year dermal carcinogenicity study may be needed; and inhalation toxicity data.

More information about nitrosamines.

Isostearamidopropyl Morpholine Lactate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…