Abstract
Conclusion
In the 1999 safety assessment of isostearamidopropyl morpholine lactate, the Cosmetic Ingredient Review (CIR) Expert Panel (Panel) concluded that this ingredient was safe for use as a cosmetic ingredient in rinse-off formulations in the (then) present concentrations and practices of use.
1
The Panel also concluded the data were insufficient to support the safety of leave-on formulations and stated that the following data were needed to support the safety of leave-on products: skin penetration; if there is significant skin penetration, then both a 28-day dermal toxicity study and reproductive and developmental toxicity study are needed; a genotoxicity study in a mammalian system; if positive, a 2-year dermal carcinogenicity study using National Toxicology Program methods may be needed; and inhalation toxicity data.
No new data were found in the published literature that would result in any new information. The Panel reaffirmed that isostearamidopropyl morpholine lactate is safe for use in cosmetics in rinse-off formulations in the practices of use and concentration as given in Table 1, and that the data are insufficient to support the safe use in leave-on formulations.
Current and Historical Frequency and Concentration of Use of Bisabolol According to Duration and Exposure.
Abbreviation: NR = no reported use.
aBecause each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses.
bConcentration of use of 1-5% in hair preparations was reported, but the types of hair preparations were not specified; therefore it is not known if the products were leave-on or rinse-off, non-coloring or coloring, or sprays.
cNot specified whether this product is a spray or a powder or neither, but it is possible it may be a spray or a powder, so this information is caputured for both categories of incidental inhalation.
Discussion
Current and historical usage and use concentration data are presented in Table 1. In 1996, it was reported to the Food and Drug Administration (FDA) Voluntary Cosmetic Registration Program (VCRP) that isostearamidopropyl morpholine lactate was used in 20-product formulations; no use concentration data were reported by industry survey. The FDA data indicate 283 uses in 2015, and the ingredient is still reported to be used in 1 leave-on formulation. According to CIR procedures, ingredients deemed to have an insufficient data conclusion but are reported to be in use according to the VCRP, will be recategorized to have a conclusion of “Use Not Supported” if the data needed are not provided within 2 years. Therefore, if no data are submitted in response to these data needs by June 2017, the conclusion will be reclassified to Use Not Supported for leave-on use.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The articles in this supplement were sponsored bu the Cosmetic Ingredient Review. The Cosmetic Ingredient Review is financially supported by the Personal Care Products Council.