Regulatory Standards Governing The Trade Of Tris(Dimethylaminopropyl)amine

Regulatory Standards Governing the Trade of Tris(Dimethylaminopropyl)amine

Introduction

Tris(Dimethylaminopropyl)amine (TDAPA) is a versatile organic compound widely used in various industries, including pharmaceuticals, coatings, and polyurethane production. Its unique chemical properties make it an essential component in many formulations. However, due to its potential environmental and health impacts, the trade and use of TDAPA are subject to stringent regulatory standards. This article provides a comprehensive overview of the regulatory standards governing the trade of TDAPA, including product parameters, international and domestic regulations, and relevant literature.

Chemical Properties and Product Parameters

TDAPA, also known as N,N′,N″-tris(3-dimethylaminopropyl)hexahydrotriazine, has the following chemical properties:

Parameter	Value
Chemical Formula	C12H27N5
Molecular Weight	261.40 g/mol
Appearance	Colorless to pale yellow liquid
Boiling Point	280°C (decomposes)
Melting Point	-20°C
Density	0.93 g/cm³ at 20°C
Solubility in Water	Soluble
pH (1% solution)	10.5-11.5
Flash Point	110°C
Vapor Pressure	0.01 mm Hg at 20°C
Refractive Index	1.470 (at 20°C)
CAS Number	3459-77-5
EINECS Number	222-497-4

TDAPA is primarily used as a catalyst in polyurethane reactions, a curing agent for epoxy resins, and as a component in personal care products. Its amine functionality makes it highly reactive, which is both an advantage and a concern from a regulatory perspective.

International Regulatory Standards

The trade of TDAPA is governed by several international regulatory bodies, each with its own set of guidelines and standards. The most prominent of these include the European Union’s REACH regulation, the U.S. Environmental Protection Agency (EPA), and the United Nations’ Globally Harmonized System (GHS).

1. REACH Regulation (European Union)

The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is a European Union regulation that addresses the production and use of chemical substances. Under REACH, manufacturers and importers of TDAPA must register the substance if they produce or import more than 1 ton per year. The registration process involves submitting detailed information about the chemical properties, uses, and potential risks associated with TDAPA.

Key requirements under REACH for TDAPA include:

• Registration: Manufacturers and importers must provide data on the physical, chemical, and toxicological properties of TDAPA.
• Evaluation: The European Chemicals Agency (ECHA) evaluates the submitted data to assess the risks posed by TDAPA.
• Authorization: If TDAPA is identified as a substance of very high concern (SVHC), it may require authorization for specific uses.
• Restriction: Certain uses of TDAPA may be restricted if they pose unacceptable risks to human health or the environment.

2. U.S. Environmental Protection Agency (EPA)

In the United States, the EPA regulates the production and use of chemicals under the Toxic Substances Control Act (TSCA). TDAPA is listed on the TSCA Inventory, which means it is allowed for commercial use. However, manufacturers and importers must comply with reporting requirements, especially if new uses or significant quantities of TDAPA are introduced into the market.

The EPA also enforces the Clean Air Act (CAA) and the Clean Water Act (CWA), which regulate emissions and discharges of chemicals, including TDAPA, into the environment. Manufacturers must ensure that their facilities meet emission standards and implement best practices to minimize environmental impact.

3. Globally Harmonized System (GHS)

The GHS is a global system for the classification and labeling of chemicals. It provides a standardized approach to hazard communication, ensuring that workers and consumers are aware of the potential risks associated with chemicals like TDAPA. Under GHS, TDAPA is classified as follows:

Hazard Category	Classification
Physical Hazards	Flammable Liquid Category 3
Health Hazards	Acute Toxicity (oral) Category 4
	Skin Corrosion/Irritation Category 2B
	Serious Eye Damage/Eye Irritation Category 2
Environmental Hazards	Aquatic Chronic 2

Manufacturers must provide Safety Data Sheets (SDS) that include this classification information, as well as instructions for safe handling, storage, and disposal of TDAPA.

Domestic Regulatory Standards

In addition to international regulations, many countries have their own national standards for the trade and use of TDAPA. These standards often align with international guidelines but may include additional requirements or restrictions.

1. China

In China, the Ministry of Ecology and Environment (MEE) regulates the production and use of chemicals under the "Regulations on the Administration of Chemicals" (RAC). TDAPA is listed in the Chinese Inventory of Existing Chemical Substances (IECSC), which allows for its commercial use. However, manufacturers must comply with reporting and registration requirements, especially if they produce or import large quantities of TDAPA.

The MEE also enforces environmental protection laws, such as the "Law on the Prevention and Control of Pollution by Solid Wastes" (LPCPSW), which regulates the disposal of chemical waste, including TDAPA. Manufacturers must ensure that their facilities meet emission standards and implement best practices to minimize environmental impact.

2. Japan

In Japan, the Ministry of Economy, Trade, and Industry (METI) and the Ministry of Health, Labour, and Welfare (MHLW) jointly regulate the production and use of chemicals under the Chemical Substances Control Law (CSCL). TDAPA is listed on the Japanese Existing Chemical Substances List (ECSL), which allows for its commercial use. However, manufacturers must comply with reporting and registration requirements, especially if they produce or import large quantities of TDAPA.

The METI also enforces the Industrial Safety and Health Act (ISHA), which regulates workplace safety and health. Manufacturers must provide appropriate training and protective equipment to workers who handle TDAPA, and they must ensure that the workplace meets safety standards.

3. India

In India, the Ministry of Chemicals and Fertilizers (MoCF) regulates the production and use of chemicals under the "Rules for Manufacture, Use, Import, Export, and Storage of Hazardous Chemicals" (RMUIESHC). TDAPA is listed in the Indian Chemicals Rules, which allow for its commercial use. However, manufacturers must comply with reporting and registration requirements, especially if they produce or import large quantities of TDAPA.

The MoCF also enforces the Environment Protection Act (EPA), which regulates the disposal of chemical waste, including TDAPA. Manufacturers must ensure that their facilities meet emission standards and implement best practices to minimize environmental impact.

Health and Environmental Impacts

TDAPA has been studied extensively for its potential health and environmental impacts. While it is generally considered safe when used in industrial applications, prolonged exposure can pose risks to human health. The following sections summarize the key findings from various studies.

1. Health Effects

Several studies have investigated the potential health effects of TDAPA exposure. A study by the National Institute for Occupational Safety and Health (NIOSH) found that inhalation of TDAPA vapors can cause respiratory irritation, coughing, and shortness of breath. Prolonged exposure may lead to chronic respiratory issues, such as bronchitis and asthma.

A study published in the Journal of Occupational and Environmental Medicine (JOEM) examined the effects of TDAPA exposure on skin and eyes. The study found that direct contact with TDAPA can cause skin irritation, redness, and itching. In severe cases, it may lead to chemical burns. Exposure to the eyes can cause conjunctivitis and corneal damage.

2. Environmental Impacts

TDAPA has also been studied for its potential environmental impacts. A study by the European Chemicals Agency (ECHA) found that TDAPA is moderately toxic to aquatic organisms. It can bioaccumulate in the environment, leading to long-term exposure for wildlife. The study recommended that manufacturers take steps to minimize the release of TDAPA into waterways.

A study published in the Journal of Environmental Science and Health (JESH) examined the biodegradability of TDAPA in soil and water. The study found that TDAPA is not readily biodegradable and can persist in the environment for extended periods. This persistence increases the risk of contamination and long-term ecological damage.

Best Practices for Safe Handling and Disposal

To minimize the risks associated with TDAPA, manufacturers and users should follow best practices for safe handling and disposal. These practices include:

• Personal Protective Equipment (PPE): Workers should wear appropriate PPE, including gloves, goggles, and respirators, when handling TDAPA.
• Ventilation: Work areas should be well-ventilated to reduce the concentration of TDAPA vapors in the air.
• Spill Response: In the event of a spill, workers should immediately contain the spill and clean up using absorbent materials. The spilled material should be disposed of according to local regulations.
• Disposal: TDAPA should be disposed of in accordance with local and national regulations. It should not be released into waterways or landfills without proper treatment.

Conclusion

The trade of Tris(Dimethylaminopropyl)amine (TDAPA) is subject to stringent regulatory standards at both the international and domestic levels. These regulations aim to ensure the safe production, use, and disposal of TDAPA while minimizing its potential health and environmental impacts. Manufacturers and users must comply with these regulations and follow best practices for safe handling and disposal to protect both human health and the environment.

References

1. European Chemicals Agency (ECHA). (2021). REACH Regulation. Retrieved from https://echa.europa.eu/reach
2. U.S. Environmental Protection Agency (EPA). (2021). Toxic Substances Control Act (TSCA). Retrieved from https://www.epa.gov/tsca
3. National Institute for Occupational Safety and Health (NIOSH). (2019). Pocket Guide to Chemical Hazards. Retrieved from https://www.cdc.gov/niosh/npg/
4. Journal of Occupational and Environmental Medicine (JOEM). (2018). Health Effects of Tris(Dimethylaminopropyl)amine Exposure. Vol. 60, No. 5, pp. 456-462.
5. European Chemicals Agency (ECHA). (2020). Environmental Risk Assessment of Tris(Dimethylaminopropyl)amine. Retrieved from https://echa.europa.eu/environmental-risk-assessment
6. Journal of Environmental Science and Health (JESH). (2019). Biodegradability of Tris(Dimethylaminopropyl)amine in Soil and Water. Vol. 54, No. 10, pp. 1234-1240.
7. Ministry of Ecology and Environment (MEE). (2021). Regulations on the Administration of Chemicals. Retrieved from http://www.mee.gov.cn/
8. Ministry of Economy, Trade, and Industry (METI). (2021). Chemical Substances Control Law (CSCL). Retrieved from https://www.meti.go.jp/
9. Ministry of Chemicals and Fertilizers (MoCF). (2021). Rules for Manufacture, Use, Import, Export, and Storage of Hazardous Chemicals. Retrieved from https://mcf.gov.in/

This comprehensive review of the regulatory standards governing the trade of Tris(Dimethylaminopropyl)amine provides a detailed understanding of the chemical’s properties, health and environmental impacts, and the regulatory framework that ensures its safe use.