Isopropyl Lanolate

Abstract

The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1980, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Isopropyl Lanolate is safe as a cosmetic ingredient in the practices of use and concentration as described in this report.

Keywords

Safety Cosmetics Isopropyl Lanolate

The Expert Panel for Cosmetic Ingredient Safety (Panel) first published the safety assessment of Isopropyl Lanolate in 1980. The Panel concluded that “on the basis of the information available, which the Expert Panel believes to have been accumulated in a reasonable manner, it is concluded that Isopropyl Lanolate is safe as currently used in cosmetic products.”¹ In 2001, following a review of data published since the 1980 publication and of updated use data, the Panel published a re-review summary affirming the original conclusion.² This current re-review is the result of an extensive search of the literature on Isopropyl Lanolate since 1998, in which no new relevant information was identified. The Panel did consider updated information regarding product types and ingredient use frequencies as reported in the US Food and Drug Administration (FDA) Voluntary Cosmetic Registration Program (VCRP) database,³ and the maximum use concentrations provided by the Personal Care Products Council.⁴ The Panel again determined to not re-open this safety assessment, reaffirming the original conclusion that Isopropyl Lanolate is safe as in cosmetics in the present practices of use and concentration, as given in Table 1.

Table 1.

Current (2019) and Historical (2001) Frequency and Maximum Concentration of Use of Isopropyl Lanolate According to Duration and Exposure.

The frequency and maximum concentrations of use have decreased since the initial re-review of Isopropyl Lanolate was considered. According to VCRP data, Isopropyl Lanolate was reported to be used in 415 formulations in 2001² but was only reported to be used in 122 formulation in 2019.³ The maximum reported concentration of use decreased from 26% in 2001² to 14.5% in 2019.⁴ Additionally, the maximum concentration of use in products that could result in incidental ingestion (lipsticks) has remained basically the same (∼14%); but, for products that result in dermal contact, that concentration has decreased from 26% (in foundations; 2001) to 6% (in eyeliners; 2019). It should also be noted that when compared to the use data included in the 1980 assessment, the decreases are even more significant; at that time, Isopropyl Lanolate was reported to be used in 1194 formulations at concentrations up to 50%.¹

Footnotes

Author’s Note

Unpublished sources cited in this report are available from the Director, Cosmetic Ingredient Review, 1620 L Street, NW, Suite 1200, Washington, DC 20036, USA.

Author Contributions

The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

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 by the Cosmetic Ingredient Review. The Cosmetic Ingredient Review is financially supported by the Personal Care Products Council.

References

Elder

, ed. Final report of the safey assessment for Isopropyl Lanolate. J Environ Pathol Toxicol. 1980;4(4):121-132.

Andersen

, ed. Annual review of cosmetic ingredient safety assessments - 2001/2001. Isopropyl Lanolate. Int J Toxicol. 2003;22:17-19.

US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) . 2019. Voluntary Cosmetic Registration Program (VCRP) - frequency of use of cosmetic ingredients. College park, MD obtained under the freedom of information act from CFSAN; requested as “frequency of use data” January 3 2019. received February 13, 2019.

Personal Care Products Council . 2019. Concentration of use by FDA product category: Isopropyl Lanolate. Unpublished data submitted by the Personal Care Products Council on April 11, 2019.