Safety Evaluations and Usage Cases of Cyclohexylamine in Cosmetics and Personal Care Products
Introduction
Cyclohexylamine (CHA) is an organic compound with the chemical formula C6H11NH2. It is a colorless liquid with a strong, ammonia-like odor and is widely used in various industrial applications, including as a raw material for the production of resins, rubber, and dyes. In recent years, CHA has also found its way into the cosmetics and personal care industry due to its unique properties. However, the safety and efficacy of CHA in these products have been subjects of extensive research and debate. This article aims to provide a comprehensive overview of the safety evaluations and usage cases of cyclohexylamine in cosmetics and personal care products, supported by detailed product parameters and references to both international and domestic literature.
Chemical Properties and Structure
Molecular Formula and Structure
- Molecular Formula: C6H11NH2
- Molecular Weight: 101.16 g/mol
- Structure: Cyclohexylamine consists of a cyclohexane ring with an amino group (-NH2) attached to one of the carbon atoms.
Physical Properties
- Appearance: Colorless liquid
- Odor: Strong, ammonia-like odor
- Boiling Point: 134.7°C (274.5°F)
- Melting Point: -19.8°C (-3.6°F)
- Density: 0.862 g/cm³ at 20°C
- Solubility: Soluble in water, ethanol, and ether
Usage in Cosmetics and Personal Care Products
Common Applications
Cyclohexylamine is used in various cosmetic and personal care products for several purposes, including:
- pH Adjuster: CHA can be used to adjust the pH of formulations, making it useful in products like shampoos, conditioners, and skin care products.
- Preservative Enhancer: It can enhance the effectiveness of preservatives, thereby extending the shelf life of products.
- Emulsifier: CHA can act as an emulsifying agent, helping to blend oil and water components in formulations.
- Surfactant: It can function as a surfactant, improving the cleansing and foaming properties of products.
Specific Product Examples
| Product Type | Application | Concentration Range |
|---|---|---|
| Shampoo | pH Adjuster | 0.1% – 0.5% |
| Conditioner | Preservative Enhancer | 0.05% – 0.2% |
| Moisturizer | Emulsifier | 0.5% – 1.0% |
| Cleanser | Surfactant | 0.2% – 0.8% |
Safety Evaluations
Toxicological Studies
Several toxicological studies have been conducted to evaluate the safety of cyclohexylamine in cosmetics and personal care products. These studies focus on various aspects, including dermal irritation, sensitization, and systemic toxicity.
- Dermal Irritation: A study by the Cosmetic Ingredient Review (CIR) Expert Panel found that cyclohexylamine can cause mild to moderate skin irritation when applied topically. However, the irritation potential is generally low at concentrations typically used in cosmetic formulations (CIR, 2010).
- Sensitization: The same study reported that cyclohexylamine has a low potential for sensitization. However, individuals with sensitive skin may experience allergic reactions (CIR, 2010).
- Systemic Toxicity: Animal studies have shown that high doses of cyclohexylamine can cause liver and kidney damage. However, these effects are not observed at the low concentrations used in cosmetics (EPA, 2015).
Regulatory Status
- United States: The Food and Drug Administration (FDA) allows the use of cyclohexylamine in cosmetics and personal care products, provided that it meets certain purity standards and does not exceed safe concentration limits (FDA, 2021).
- European Union: The European Commission’s Scientific Committee on Consumer Safety (SCCS) has evaluated cyclohexylamine and concluded that it is safe for use in cosmetics at concentrations up to 1% (SCCS, 2018).
- China: The Chinese National Health Commission (NHC) permits the use of cyclohexylamine in cosmetics, with specific concentration limits and safety guidelines (NHC, 2020).
Case Studies and Practical Applications
Case Study 1: Shampoo Formulation
A leading hair care brand developed a new shampoo formulation using cyclohexylamine as a pH adjuster. The formulation included:
- Active Ingredients: Sodium Lauryl Sulfate (SLS), Cocamidopropyl Betaine, Panthenol
- Cyclohexylamine Concentration: 0.3%
- pH Range: 5.5 – 6.5
The shampoo was tested in a consumer trial involving 100 participants. Results showed that the product effectively cleaned the scalp and hair without causing significant irritation or allergic reactions. The pH stability of the formulation was maintained over a six-month period, demonstrating the effectiveness of cyclohexylamine as a pH adjuster (Smith et al., 2019).
Case Study 2: Moisturizer Development
A skincare company formulated a moisturizer using cyclohexylamine as an emulsifier. The key ingredients included:
- Active Ingredients: Glycerin, Hyaluronic Acid, Dimethicone
- Cyclohexylamine Concentration: 0.7%
- Texture: Lightweight, non-greasy
The moisturizer was subjected to a clinical trial involving 50 volunteers. The results indicated that the product improved skin hydration and elasticity without causing any adverse reactions. The emulsifying properties of cyclohexylamine contributed to the stable and homogeneous texture of the moisturizer (Johnson et al., 2020).
Conclusion
Cyclohexylamine is a versatile ingredient with multiple applications in cosmetics and personal care products. Its ability to adjust pH, enhance preservative effectiveness, and act as an emulsifier and surfactant makes it a valuable component in various formulations. However, its use must be carefully managed to ensure safety and compliance with regulatory guidelines. Future research should continue to monitor the long-term effects of cyclohexylamine in cosmetic products and explore new applications in the industry.
References
- CIR (Cosmetic Ingredient Review). (2010). Final Report on the Safety Assessment of Cyclohexylamine. International Journal of Toxicology, 29(1), 1-15.
- EPA (Environmental Protection Agency). (2015). Integrated Risk Information System (IRIS) for Cyclohexylamine. Retrieved from https://www.epa.gov/iris
- FDA (Food and Drug Administration). (2021). Guidance for Industry: Voluntary Cosmetic Registration Program (VCRP). Retrieved from https://www.fda.gov/cosmetics/guidance-documents-cosmetics/voluntary-cosmetic-registration-program-vcrp
- SCCS (Scientific Committee on Consumer Safety). (2018). Opinion on Cyclohexylamine. Retrieved from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_198.pdf
- NHC (National Health Commission of China). (2020). Standards for the Use of Cosmetics Ingredients. Retrieved from http://www.nhc.gov.cn/
- Smith, J., Brown, L., & Davis, M. (2019). Evaluation of Cyclohexylamine as a pH Adjuster in Shampoo Formulations. Journal of Cosmetic Science, 70(5), 345-356.
- Johnson, R., Wilson, K., & Thompson, H. (2020). Development and Clinical Evaluation of a Cyclohexylamine-Based Moisturizer. International Journal of Dermatology, 59(4), 456-465.