Regulatory Standards Governing the Use of Dicyclohexylamine in Cosmetics

Abstract

Dicyclohexylamine (DCHA) is an organic compound that has found applications in various industries, including cosmetics. However, its use in cosmetic products is subject to strict regulatory standards due to potential health and environmental concerns. This paper aims to provide a comprehensive overview of the regulatory standards governing the use of dicyclohexylamine in cosmetics. It will delve into product parameters, safety assessments, and compliance requirements, supported by relevant international and domestic literature. The article also includes detailed tables summarizing key regulations and references for further reading.

Introduction

Dicyclohexylamine, with the chemical formula C12H24N, is a colorless liquid or solid at room temperature. It is used in cosmetics primarily as a pH adjuster and buffering agent. Given its wide application, it is crucial to understand the regulatory landscape surrounding its use. This section provides an overview of the importance of regulatory standards and the role they play in ensuring consumer safety.

Chemical Properties and Uses

Property	Description
Molecular Formula	C12H24N
Molecular Weight	188.32 g/mol
Melting Point	27-29°C
Boiling Point	265°C
Solubility in Water	Insoluble

Dicyclohexylamine is commonly used in cosmetic formulations to adjust the pH of products such as creams, lotions, and shampoos. Its ability to buffer solutions makes it valuable in maintaining the stability of these products over time.

Regulatory Frameworks

The regulatory frameworks for dicyclohexylamine in cosmetics vary across different regions. Key regulatory bodies include:

1. European Union (EU)

   • Cosmetic Regulation (EC) No 1223/2009: Specifies permissible levels and conditions for the use of dicyclohexylamine.
   • Scientific Committee on Consumer Safety (SCCS): Provides safety assessments and recommendations.

2. United States (US)

   • Food and Drug Administration (FDA): Regulates the use of dicyclohexylamine under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
   • Cosmetic Ingredient Review (CIR): Conducts safety reviews and publishes guidelines.

3. Asia-Pacific Region

   • China: Governed by the National Medical Products Administration (NMPA) and follows the "Regulations on Supervision and Administration of Cosmetics."
   • Japan: Regulated by the Ministry of Health, Labour and Welfare (MHLW).

Safety Assessments and Compliance Requirements

Safety assessments are critical to ensure that dicyclohexylamine does not pose any undue risks to consumers. These assessments typically involve:

1. Toxicological Studies

   • Acute toxicity tests
   • Chronic toxicity tests
   • Skin irritation and sensitization studies

2. Risk Assessment

   • Exposure assessment
   • Hazard characterization
   • Risk characterization

Study Type	Findings	Reference
Acute Toxicity	LD50 > 5000 mg/kg (oral)	OECD Guideline 423
Chronic Toxicity	No observed adverse effect level (NOAEL) at 100 mg/kg/day	OECD Guideline 452
Skin Irritation	Mild irritant at concentrations above 5%	OECD Guideline 404

Product Parameters and Formulation Guidelines

Formulating cosmetics with dicyclohexylamine requires adherence to specific parameters to ensure both efficacy and safety. Below are some recommended guidelines:

Parameter	Recommended Range
pH Adjustment	pH 5.0-7.5
Concentration	≤ 1%
Stability Testing	Shelf life ≥ 24 months

International and Domestic Literature Review

Several studies have been conducted to evaluate the safety and efficacy of dicyclohexylamine in cosmetics. Notable contributions include:

1. International Journal of Cosmetic Science (IJCS)

   • A study published in IJCS evaluated the skin irritation potential of dicyclohexylamine. The results indicated that concentrations below 5% were generally well-tolerated.

2. Journal of Applied Toxicology (JAT)

   • Research in JAT explored the chronic toxicity of dicyclohexylamine in animal models. The findings suggested that long-term exposure at high doses could lead to liver damage.

3. Chinese Journal of Dermatology

   • A domestic study assessed the allergenic potential of dicyclohexylamine in human subjects. The research concluded that allergic reactions were rare but possible.

Case Studies and Practical Applications

Case studies provide real-world insights into the use and regulation of dicyclohexylamine in cosmetics. For instance, a case study from the EU examined the reformulation of a popular moisturizer to comply with new safety standards. The manufacturer successfully reduced the concentration of dicyclohexylamine while maintaining product performance.

Conclusion

In conclusion, the regulatory standards governing the use of dicyclohexylamine in cosmetics are stringent and multifaceted. Ensuring compliance with these standards is essential to protect consumer health and maintain product quality. Future research should focus on developing safer alternatives and refining existing formulations.

References

1. European Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
2. Food and Drug Administration (FDA). (2021). Federal Food, Drug, and Cosmetic Act (FD&C Act).
3. Scientific Committee on Consumer Safety (SCCS). (2020). Opinion on Dicyclohexylamine.
4. OECD Guidelines for the Testing of Chemicals. (2018). Test No. 423: Acute Oral Toxicity – Acute Toxic Class Method.
5. OECD Guidelines for the Testing of Chemicals. (2018). Test No. 452: Chronic Toxicity Studies.
6. OECD Guidelines for the Testing of Chemicals. (2018). Test No. 404: Acute Dermal Irritation/Corrosion.
7. International Journal of Cosmetic Science. (2019). Evaluation of skin irritation potential of dicyclohexylamine.
8. Journal of Applied Toxicology. (2020). Chronic toxicity of dicyclohexylamine in animal models.
9. Chinese Journal of Dermatology. (2021). Allergenic potential of dicyclohexylamine in human subjects.

This comprehensive review underscores the importance of adhering to regulatory standards for the safe and effective use of dicyclohexylamine in cosmetics.