Azo Dyes in Pigments

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2. Larger Context

Azo dyes are a distinct type of dye, known for their azo groups. These groups consist of two nitrogen atoms joined by a double bond like two nitrogen atoms tightly holding hands.

These dyes are significant in the dye industry, comprising about 60-70% of all used across various sectors. There are over 2,000 types of azo dyes in the market, highlighting their popularity. They color various materials, including natural fibers like cotton, silk, wool, synthetic plastics and rubber. Azo dyes are also found in paints and varnishes. Their most common applications are in textiles (such as sportswear, swimsuits, underwear, hats, towels), leather goods (like handbags, wallets, chair covers, briefcases, jackets, footwear), accessories (wristwatch straps, wigs, gloves, sleeping bags), and cosmetics, particularly in pigments.

Why are azo dyes so widely used? They are cost-effective and easy to apply, offering bold and vibrant colors. From a bright red shirt to a vividly colored plastic item, azo dyes are often responsible for these hues. Thus, their use remains appealing, especially in many Asian countries where certain regulations and application methods are permitted.

3. Azo Dyes in Pigments

A pigment bottle with its contents explained in different categories.

We need context to comprehend Azo Dyes in permanent makeup (PMU). "Pigment" in PMU refers to a mix of colorants and additives like solubles, binders, fillers, and preservatives. Colorants are classified into Pigments, Dyes, and Lacquers.

Pigments

Pigments are insoluble color particles mixed with a carrier to form ink or pigment paste. They're made from various materials, including minerals, metals, or organic compounds. Pigments, known for their stability and fade resistance, are ideal for permanent or semi-permanent applications like tattoos and Powder Brows. Common inorganic pigments include iron oxides and titanium dioxide.

Dyes

Dyes differ from pigments as they are soluble and produce color by absorbing light. They're generally less stable than pigments and can fade faster under environmental factors like sunlight or water. Thus, they are less suitable for permanent applications but are used in textiles and other temporary color applications. Azo dyes, organic compounds, have raised health and safety concerns.

Lacquers

Lacquers are dyes made insoluble by precipitation or adsorption onto a substrate, making them behave more like pigments. They are used less in permanent makeup due to safety concerns and regulations.

While pigments, dyes, and lacquers are all colorants, they differ in chemical properties and uses. In discussing Azo Dyes, our focus is on “dyes.”

Dyes - Organic Pigment Colorants

Colorants can be inorganic or organic. Inorganic pigments, like Titanium Dioxide and Iron oxide, are used in various applications, including cosmetics and permanent makeup. Organic pigments are carbon-based, derived from petrochemicals or natural sources, like Phthalocyanine Blue and Quinacridone pigments.

Classification of Dyes in Semi-Permanent Makeup

Different classes of dyes include the following.

Azo Dyes: Known for vibrant colors and affordability.
Anthraquinone Dyes: Bright and stable colors.
Indigoid Dyes: Subset or synthetic form of Indigo dyes.
Phthalocyanine Dyes: Stable blues and greens.
Nitro and Nitroso Dyes: Less common in semi-permanent makeup.
Triarylmethane and Xanthene Dyes: Bright, traditional colors.
Quinone-imine Dyes: Yellows, oranges, and reds.
Sulfur Dyes: Used in textiles for dark colors.
Dyes are primarily organic, containing carbon and hydrogen atoms.
Azo Dyes Color Index Range - CI 11,000 to 36,999

The Color Index (CI) is a standardized naming system for colorants. Each colorant has a unique CI number for consistency in the industry. CI codes can indicate if a pigment is organic or inorganic.

Organic Pigments: CI 10,000 to 76,999, used in various applications.
Inorganic Pigments: CI 77,000 to 77,999 for stability and fade resistance.
Azo Dyes: Generally within CI 11,000 to 36,999.

Understanding these classifications helps artists and manufacturers communicate accurately about specific colors.

4. Colorants with Azo Dyes

Due to varying regulations and safety standards, Azo dyes are used differently across regions. Below is a list of well-known colorants containing Azo dyes, presented with their Color Index (CI) codes.

CI 11767: Yellow Pigment 97
CI 11783: Yellow Pigment Yellow 120
CI 12475 or 12475:1: Red Pigment Red 170
CI 14700: Red 4
CI 15510: Orange 1
CI 15850: Red 7
CI 15985: FD&C Yellow 6
CI 16035: Red 40
CI 19140:1: FD&C Yellow 5

It's important to remember that this list is not comprehensive, and new Azo dyes may enter the market. Additionally, a CI code doesn't guarantee the pigment's safety for all uses. Artists are likely familiar with colorants like Yellow 120, Red 170, Yellow 5, and Yellow Pigment 97 from their pigment bottles.

5. The Risks Related to Azo Dyes

Firstly, some Azo dyes can decompose into substances called aromatic amines, which are a significant concern. These amines are known to be toxic and potentially carcinogenic, meaning they can cause cancer. Applying something with this potential risk directly onto the skin, as in semi-permanent makeup, is not to be taken lightly.

Secondly, allergies to Azo dyes are possible. In semi-permanent brow makeup, this could lead to prolonged skin irritation or severe allergic reactions. The risks are not just temporary discomfort but may include swelling, redness, and other distressing symptoms, particularly concerning when they affect the face.

Thirdly, in many regions, the use of Azo dyes in cosmetics, including semi-permanent makeup, is restricted or banned due to these health risks. Using them could mean operating outside legal boundaries, potentially leading to legal issues.

How Azo Dyes Become Carcinogenic

Azo dyes can become carcinogenic through photodegradation, activated by ultraviolet (UV) light exposure. UV light can break chemical bonds in molecules, including in azo dyes, causing them to decompose into smaller, potentially harmful components like o-anisidine.

These degraded particles are small enough to penetrate cellular structures in the human body. Once inside a cell, they can interact with various components, including DNA. Contact with DNA can lead to mutations and changes in the DNA sequence, making them mutagenic. Over time, these mutations can disrupt normal cell functions, leading to uncontrolled cell division, a process known as becoming carcinogenic or cancer-causing.

The cell nucleus, which houses DNA, is particularly susceptible. If DNA in the nucleus is altered or damaged and the cell cannot repair it, this could initiate cancer development.

6. Laser Removal and Azo Dyes

Laser removal, similar to UV light exposure, can lead to the breakdown of molecules and potentially release carcinogenic substances. Here's an explanation of how this occurs.

Generation of Carcinogenic Elements

Laser removal uses concentrated beams of light to disintegrate pigments in the skin, a process known as photothermolysis. The laser targets the pigment, breaking it into smaller particles, making them easier to remove or absorb by the body.

The issue arises when these pigments include azo dyes, which can decompose into harmful components like o-anisidine. Laser energy, like UV light, can disrupt the chemical structure of these dyes. Consequently, the laser might unintentionally cause the release of potentially carcinogenic or mutagenic substances.

Formation of Carcinogenic Cells

The hazardous particles produced can penetrate the body's cells, mirroring the process of UV-triggered degradation. Inside the cell, they can interact with components, notably the DNA in the nucleus. If these particles induce DNA mutations, this can lead to abnormal cell growth, potentially resulting in carcinogenic conditions or cancer development.

7. REACH and Azo Dyes

In the European Union, regulating chemicals, including those in semi-permanent pigments for lip blush, is primarily overseen by REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals). REACH is a comprehensive system aimed at limiting the use of chemicals harmful to human health.

Scrutinized Aromatic Amine Compounds

Under REACH, azo dyes or azo colorants, which can break down into amines under certain conditions like hydrolysis, are closely monitored. These amines can be hazardous. Specifically, REACH's Appendix 8 lists 24 aromatic amine compounds identified as carcinogenic or harmful to human well-being.

This indicates that REACH keeps a record of aromatic amine compounds, including carcinogenic ones, in its Appendix 8. Pigments containing azo dyes that may degrade into these banned amines are restricted within the EU. It's essential to understand that not all amines are prohibited, only those explicitly listed.

Regulation (EC) No. 1223/2009

Regulation (EC) No. 1223/2009 is also relevant for cosmetics, including brow pigments. This regulation imposes additional safety measures, particularly targeting certain azo dyes like o-dianisidine and Benzidine-based ones, banned in cosmetics due to their potential risks.

EU Ecolabel

Apart from regulatory frameworks, the EU Ecolabel Scheme is a voluntary program that awards an eco-friendly certification, symbolized by a flower-like label, to various consumer products, including cosmetics and pigments. Products with this label meet specific ecological criteria, indicating safety for consumer use. However, the label primarily denotes environmental friendliness and does not guarantee 100% safety for all uses or individuals.

Lab Testing

To comply with these strict regulations, third-party lab testing is essential. This testing checks if a product contains restricted azo dyes in prohibited concentrations. Renowned testing agencies include Eurofins, QIMA, SGS, CIRS, and ATS. These labs assist in determining which azo dyes need testing for particular products and provide updates on changes to the list of restricted azo dyes and their allowable limits.

8. Problems with REACH

A significant issue with REACH regulations for semi-permanent makeup (PMU) pigments is that no colorants used in PMU were initially developed for the makeup industry. They are general-purpose colorants designed for various applications, creating a regulatory gap as no specific list of colorants is approved for PMU.

A Long List of Unregulated Organic Compounds

This absence of tailored guidelines allows manufacturers to use various unregulated organic components in their pigments. This extensive, poorly monitored list poses a substantial safety concern.

Inconsistent Laboratory Testing

Another problem is inconsistent lab testing. Sometimes, the final product differs from the approved sample sent for testing. This issue is particularly noticeable among Asian manufacturers eager to enter the EU market, who may sacrifice quality and safety for cost savings. They might use laboratories susceptible to manipulation, emphasizing the need for vigilance and thorough verification by consumers and professionals.

“Telepathical Testing” and the Risks of Cheap Pigments

Caution is necessary due to instances of lax regulatory compliance. Standard procedure mandates sending a sample to a certified lab for analysis, but there have been loopholes. For instance, despite having ISO 17025 certification, some labs in post-Soviet countries have issued test reports without physically receiving or examining any sample.

These labs conduct "telepathic testing," issuing certificates based solely on payment, posing a significant consumer risk. This underscores the importance of carefully selecting pigments and procedures like laser removal. Artists should avoid cheap pigments, and customers should be aware of the brands used by their artists.

Fake Certificates in Online Sales

Moreover, many online stores sell pigments accompanied by dubious certificates or paperwork signed by unqualified individuals. This practice, unfortunately common in some Asian countries, highlights the need for thorough background checks and validation of pigment sources.

9. Regulation in the US and Elsewhere

In the United States, the regulation of azo dyes varies by industry. The Food and Drug Administration (FDA) enforces rules on certain azo dyes in foods, drugs, and cosmetics. For instance, some azo dyes are prohibited in food products due to health concerns.

There's no comprehensive federal ban on azo dyes in the textile and apparel sector. However, states like California have specific regulations restricting certain chemicals, including azo dyes, that can degrade into carcinogenic amines.

Less Stringent than Europe

Azo dyes fall under the FDA's purview as color additives for semi-permanent makeup pigments. The FDA permits color additives for certain applications and mandates compliance with purity standards and safety conditions. However, the regulatory framework in the U.S. is often seen as less stringent compared to the European Union, where REACH imposes tighter controls.

Lax Regulations in Developing Countries

Many developing countries and regions with informal economies lack comprehensive regulations on azo dyes. This is often due to resource constraints, local policies, or insufficient awareness of the risks associated with these substances. As a result, products made or imported in these areas may contain unregulated or banned azo dyes.

10. Conclusions

In permanent makeup (PMU), all pigments contain either pigments or dyes as colorants. Azo Dyes range from CI 11,000 to CI 36,999 within the organic dyes category.

Azo dyes are an affordable option for producing vibrant, attractive colors. These dyes are found in various consumer products, including textiles, leather goods, accessories, and cosmetics like PMU pigments for Lip Blush.

While Azo dyes in pigments are generally safe, they can sometimes cause allergies. However, their safety concern mainly arises when exposed to UV light or during laser removal procedures. Under these conditions, Azo dyes can decompose into aromatic amines, such as o-anisidine, through photodegradation. This degradation can lead to mutagenic effects, altering the DNA sequence and potentially causing uncontrollable cell division, known as carcinogenesis.

In developing countries, regulations on Azo dyes are virtually non-existent. In the USA, the FDA regulates these dyes to a certain extent. In Europe, the use of pigments is mainly governed by the REACH regulation. Despite this, not all pigments on the market are guaranteed to be safe. Since pigments are not exclusively created for the beauty industry, some manufacturers may use various organic dyes, including unregulated components. Furthermore, issues with fake certificates and corrupt practices in certification have been observed. Therefore, purchasing from reputable manufacturers is crucial to ensure the quality and safety of pigments.

Azo Dyes in Pigments

"Azo dyes may not be as harmless as they appear. While some concerns about harmful pigment substances are overstated, Azo dyes can be risky in specific situations. Our article delves deeply into this topic to provide a clearer understanding."

1. Background

2. Larger Context

3. Azo Dyes in Pigments

Pigments

Dyes

Lacquers

Dyes - Organic Pigment Colorants

Classification of Dyes in Semi-Permanent Makeup

4. Colorants with Azo Dyes

5. The Risks Related to Azo Dyes

How Azo Dyes Become Carcinogenic

6. Laser Removal and Azo Dyes

Generation of Carcinogenic Elements

Formation of Carcinogenic Cells

7. REACH and Azo Dyes

Scrutinized Aromatic Amine Compounds

Regulation (EC) No. 1223/2009

EU Ecolabel

Lab Testing

8. Problems with REACH

A Long List of Unregulated Organic Compounds

Inconsistent Laboratory Testing

“Telepathical Testing” and the Risks of Cheap Pigments

Fake Certificates in Online Sales

9. Regulation in the US and Elsewhere

Less Stringent than Europe

Lax Regulations in Developing Countries

10. Conclusions