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2. Larger context

Azo dyes are a specific type of dye characterized by their azo groups. An azo group consists of two nitrogen atoms connected by a double bond. In simpler terms, think of it as a pair of nitrogen buddies holding hands really tightly.

These azo dyes are big players in the dye world, making up about 60-70% of all dyes used in various industries. To give you a sense of their popularity, there are over 2,000 different types of azo dyes available in the market today. They're used for coloring various materials, from natural fibers like cotton, silk, and wool to man-made items like plastic and rubber. They even show up in paints and varnishes. Most common use cases are textiles: sportswear, swimsuits, underwear, hats, towels, etc.; leather goods: handbags, purses, wallets, chair covers, neck pouches, briefcases, leather jackets, and footwear; accessories: wristwatch straps, wigs, gloves, sleeping bags, etc, and among other things cosmetic products, such as colorants used in pigments.

Why are Azo dyes so commonly used?

The simple answer is that they are cost-effective and simple to apply. Plus, they pack a punch in the color department, offering bold and vibrant hues that really stand out. Whether it's a bright red shirt or a vividly colored piece of plastic, chances are, azo dyes had something to do with it. Thus, as long as there are some jurisdictions and ways to use it, using such dyes remains a very tempting option - especially in many Asian countries.

3. Azo dyes in pigments

On the left is a pigment bottle with the classification of its contents, breaking it down to colorants and additives and then colorants to dyes, pigments, and lacquers, and then all the way to Azo dyes. An attractive woman on the right.

To understand Azo Dyes, we first need some context. The term "Pigment" in the world of PMU refers to the final mixture of colorant and additives (solubles, binders, fillers, preservatives). Colorants can further be divided into Pigments, Dyes, and Lacquers.

Pigments

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

Dyes

In contrast to pigments, dyes are soluble substances that produce color by absorbing light. They are generally less stable than pigments and can fade more quickly when exposed to environmental factors like sunlight or water. For these reasons, dyes are generally unsuitable for permanent applications but are often used in textiles and other temporary color applications. One example is azo dyes, which are organic compounds that have raised health and safety concerns.

Lacquers

Lacquers are essentially dyes that have been rendered insoluble by precipitation or adsorption onto a substrate. This makes them behave more like pigments. They are less frequently used in permanent makeup applications due to potential safety concerns and regulations.

Thus, while pigments, dyes, and lacquers all serve as colorants, they differ in their chemical properties and uses. When discussing Azo Dyes, we focus on the colorant type known as “dyes.”

Dyes - organic pigment colorants

In the realm of colorants, pigments can indeed be either inorganic or organic. Inorganic pigments are typically derived from mineral sources. For example, Titanium Dioxide and Iron oxide are inorganic pigments commonly used in various applications, including cosmetics and permanent makeup like Powder Brows.

Organic pigments, on the other hand, are carbon-based and often derived from petrochemicals, though they can also come from plant or animal sources. Examples include Phthalocyanine Blue and Quinacridone pigments.

Classification of dyes in semi-permanent makeup

Now, when we have context for the dyes, let us explore their different classes. Those are the following.

Azo Dyes - known for vibrant colors and affordability.
Anthraquinone Dyes - appreciated for their bright and stable colors.
Indigoid Dyes - these can be considered a subset or a synthetic form of the Indigo dyes.
Phthalocyanine Dyes - stable blues and greens.
Nitro and Nitroso Dyes - these dyes are less commonly used in semi-permanent makeup and are classified in chemical-based classification.
Triarylmethane and Xanthene Dyes - are known for their bright and traditional colors.
Quinone-imine Dyes - range of yellows, oranges, and reds.
Sulfur Dyes - are often used in textiles for dark colors like blacks and browns.

When it comes to all dyes, they are primarily organic in nature. This means that dyes contain carbon atoms and hydrogen atoms in their molecular structure, aligning with the chemical definition of “organic.” Examples include Azo dyes and Anthraquinone dyes.

Azo dyes color index range - CI 11,000 to 36,999

The Color Index (CI) is a standardized colorant naming scheme used internationally for easy identification and classification. Each colorant is assigned a unique CI number, allowing for industry consistency. This is especially beneficial for artists and manufacturers to communicate accurately about specific colors.

According to the Color Index system, CI codes assigned to pigments can help indicate whether a pigment is organic or inorganic.

Organic Pigments: CI 10,000 to 76,999. Organic pigments typically have CI codes ranging from 10,000 to 76,999. These are carbon-based pigments, often used in various applications, from cosmetics to inks.

Inorganic Pigments: 77,000 to 77,999. Inorganic pigments usually have CI codes from 77,000 to 77,999. These are mineral-based and often used in permanent and semi-permanent applications due to their stability and fade resistance.

Azo dyes. As for Azo dyes, they generally fall within the CI codes of 11,000 to 36,999.

5. The risks related to Azo Dyes

First off, some Azo dyes can break down into substances called aromatic amines. These amines are a big red flag because they're known to be toxic and can be carcinogenic - that means they can cause cancer. Imagine applying something with that potential directly to your skin in the form of semi-permanent makeup. It's not a risk you want to take lightly.

Second, people can be allergic to Azo dyes. When used in something as permanent as a brow pigment, this can lead to long-term skin irritation or even severe allergic reactions. It's not just a matter of having an itchy brow for a few days; we're talking about potential swelling, redness, and other symptoms that nobody wants to deal with, especially on their face.

Third, in many places, Azo dyes are either restricted or outright banned for use in cosmetics, including semi-permanent makeup, due to these health risks. That means if you're using them, you might be operating outside of local laws, which can expose you to legal issues.

How Azo Dyes Become Cancerogenic

Azo dyes can become carcinogenic through a process known as photodegradation, which is triggered by exposure to ultraviolet (UV) light. UV light has enough energy to break chemical bonds in molecules, including those in azo dyes. When this happens, the dye can break down into smaller components like o-anisidine, which are potentially harmful.

These tiny, degraded particles are small enough to penetrate the human body's cellular structure. Once inside the cell, they can interact with cellular components, including DNA.

When these particles come into contact with DNA, they can cause mutations, which is a change in the DNA sequence. This is referred to as being "mutagenic." Over time, these mutations can disrupt normal cell regulation, leading the cell to divide uncontrollably—this is what's known as becoming "carcinogenic" or cancer-causing.

The nucleus of the cell, where the DNA resides, is particularly vulnerable. If the DNA within the nucleus is altered or damaged and the cell doesn't have a way to repair it, this can trigger the path toward cancer development.

6. Laser removal and Azo Dyes

Laser removal can also cause the breakdown of molecules like UV light, potentially releasing carcinogenic substances. Here's how it works.

Generation of carcinogenic elements

Laser removal techniques use concentrated beams of light energy to break down pigments embedded in the skin. This process is called photothermolysis. The laser's light energy targets the pigment, breaking it into smaller particles so that they can be more easily removed or absorbed by the body.

The problem arises when these pigments contain substances like azo dyes, which can break down into harmful components like o-anisidine. Like UV light, the laser energy has the potential to disrupt the chemical structure of these dyes. When that happens, the laser can inadvertently cause the release of potentially carcinogenic or mutagenic substances.

Formation of carcinogenic cells

Once these smaller, hazardous particles are produced, they can enter the body's cells just like in the case of UV-triggered degradation. Inside the cell, they can interact with cellular components, including the DNA within the nucleus. If these particles cause mutations in the DNA, it can lead to abnormal cell growth and eventually result in carcinogenic or cancer-causing conditions.

7. REACH and Azo Dyes

In the European Union, regulating chemicals, including those used in semi-permanent pigments for powder brows, is primarily governed by REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals). REACH is a robust framework designed to restrict the use of chemicals that risk human health.

Scrutinized aromatic amine compounds

Among the substances scrutinized under REACH are azo dyes or azo colorants, which can decompose into amines under certain conditions like hydrolysis. These amines can be harmful. In fact, REACH's Appendix 8 specifically lists 24 kinds of aromatic amine compounds that are either carcinogenic or otherwise detrimental to human well-being.

This means that REACH maintains a list of aromatic amine compounds in its Appendix 8 that are considered harmful, including carcinogenic ones. Pigments containing azo dyes that have the potential to break down into these prohibited amines are restricted in the EU. It's important to note that not all amines are banned, but those that are specifically listed.

Regulation (EC) No. 1223/2009

For cosmetics, including brow pigments, Regulation (EC) No. 1223/2009 also comes into play. This regulation outlines additional safety measures, focusing explicitly on certain prohibited azo dyes like o-dianisidine and Benzidine-based ones. These are banned in cosmetics due to their potential harm.

EU Ecolabel

Beyond regulatory frameworks, the EU Ecolabel Scheme is a voluntary system that provides an eco-friendly seal of approval, denoted by a flower-like label, to various consumer products. These include cosmetics and pigments. Products carrying this label meet particular ecological criteria and are considered safe for consumer use. Thus, if a product carries the EU Ecolabel, it has met a specific set of ecological criteria, making it less likely to contain harmful substances. However, it's important to specify that the label is a marker of environmental friendliness and doesn't directly imply that a product is 100% safe for all uses or individuals.

Lab testing

To ensure compliance with these stringent regulations, third-party lab testing is crucial. This testing verifies whether your product contains restricted azo dyes in prohibited concentrations. Some of the well-known testing agencies include Eurofins, QIMA, SGS, CIRS, and ATS. These labs can also advise you on which azo dyes require testing for your specific product and update you on any changes to the list of restricted azo dyes and their allowable limits.

8. Problems with REACH

No pigment is actually created for the cosmetic industry. The issue with REACH regulations for semi-permanent makeup (PMU) pigments is rooted in a key fact: none of the colorants used in PMU pigments were originally developed for the makeup industry. They are general-use colorants designed for a broad range of applications. This means there's no specialized list of colorants and dyes that are permitted for use in PMU pigments, leading to a regulatory gap.

A long list of unregulated organic compounds

This lack of industry-specific guidelines allows manufacturers to get creative, using various unregulated organic components in their pigments. The list of such components is extensive and isn't adequately monitored, making it a significant concern.

Laboratories can be gamed

Additionally, there's the issue of inconsistent lab testing. While paperwork might be for a sample sent to a laboratory, there are cases where the final product doesn't match the approved sample. This is particularly true among some Asian manufacturers who are keen to enter the EU market but may prioritize cost savings over quality and safety. These manufacturers may use labs that can be manipulated, making it even more crucial for consumers and professionals to exercise caution and due diligence.

“Telephatical testing” - why you should not use cheap pigments

It's essential to be cautious, as there can be instances where regulatory compliance isn't as rigorous as it should be. Though the standard procedure requires sending a sample to a certified lab for analysis, some loopholes exist. For example, there have been cases where laboratories in post-Soviet countries, despite having ISO 17025 certification, issued test reports without physically receiving or analyzing any sample.

These labs have, in essence, "telepathically tested" the product, providing documentation solely based on the fee being paid. This creates a serious consumer risk and highlights the need for thorough due diligence when selecting pigments and undergoing procedures like laser removal. That is one reason why, as an artist, you should not use cheap pigments and why, as a customer, you should always know what brand pigments your artists use.

Additionally, many online stores sell pigments with absurd fake certificates or paperwork signed by a random person without the credentials to analyze the substances. Unfortunately, this is sometimes the standard in some Asian countries.

9. Regulation in the US and elsewhere

In the United States, azo dyes are not broadly restricted across all industries, but they are subject to regulation in specific contexts. For example, the Food and Drug Administration (FDA) has regulations in place concerning the use of certain azo dyes in foods, drugs, and cosmetics. Some azo dyes are banned in food products due to potential health risks.

In the textile and apparel industry, while there isn't a comprehensive federal ban on azo dyes, certain states like California have their own regulations that restrict the use of specific chemicals, including some azo dyes that can break down into carcinogenic amines.

Looser than in Europe

In the case of semi-permanent makeup pigments, azo dyes would be regulated as color additives under the FDA's guidelines. The FDA approves color additives for specific uses and requires manufacturers to adhere to purity standards and other conditions for safe use. However, it's essential to note that the U.S. approach to chemical regulation is generally considered to be less precautionary than that of the European Union, which has more stringent restrictions under REACH and other regulations.

Wild West

Many developing countries and areas with informal economies have no comprehensive regulations on azo dyes, often due to limited resources, local policies, or a lack of awareness about the potential hazards associated with these substances. This means that locally produced or imported products in these regions may contain and do contain unregulated and banned azo dyes.

10. Conclusions

All pigments used in PMU have either pigments or dyes as colorants. Within the organic dyes, there's a color range for Azo Dyes: CI 11,000 to CI 36,999.

Azo dyes are a relatively cheap way to produce vibrant, beautiful colors. These dyes are used in various consumer products like textiles, leather goods, accessories, and cosmetic products, including PMU pigments for Powder Brows.

Azo dyes in pigments are generally not dangerous by themselves, although they can sometimes cause allergies. However, when exposed to UV light or a laser removal procedure, Azo dyes can break down into aromatic amines, such as o-anisidine. This breakdown is known as photodegradation. When these particles come into contact with DNA, they can cause mutations. This change in the DNA sequence is known as being "mutagenic." Over time, these mutations can disrupt normal cell function, causing cells to divide uncontrollably. This is referred to as being "carcinogenic" or cancer-causing.

In developing countries, there are effectively no regulations on using Azo dyes. In the USA, the FDA regulates them to some extent. Regarding pigments, regulations are mainly enforced by the EU through its REACH regulation package. However, this doesn't guarantee that all sold pigments are safe. Since no pigments are created solely for the beauty industry, various organic dyes can be used. There's also a long list of unregulated components that some creative producers use. Additionally, some producers sell pigments with fake certificates online or obtain documentation through corrupt means. This means the only way to ensure pigment quality is to buy from reputable producers.

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