Antioxidant 1024: A Safe and Versatile Choice for Medical Devices and Food Contact Applications
When it comes to the world of polymers, additives are like spices in a chef’s kitchen—used in small quantities, but capable of transforming the performance, durability, and safety of the final product. Among these additives, antioxidants play a critical role in protecting materials from degradation caused by heat, light, or oxygen exposure. One such antioxidant that has gained increasing attention over the years is Antioxidant 1024, especially due to its excellent toxicological profile and broad applicability in both medical devices and food contact applications.
But what exactly is Antioxidant 1024? Why is it considered safe? And how does it perform under real-world conditions? Let’s dive into this fascinating compound and explore why it might just be one of the unsung heroes behind many everyday products we trust with our health and food safety.
What Is Antioxidant 1024?
Antioxidant 1024, also known as Irganox® 1024, is a high-performance hindered phenolic antioxidant developed by BASF (formerly Ciba-Geigy). Its chemical name is N,N’-hexane-1,6-diylbis(3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide)), which might look intimidating at first glance, but let’s break it down:
- It contains two phenolic antioxidant moieties, each based on the well-known structure of BHT (butylated hydroxytoluene).
- These are connected via a hexamethylene diamide bridge, making it a dual-functional antioxidant.
- The presence of tert-butyl groups enhances its thermal stability and resistance to volatilization during processing.
In simpler terms, it’s a molecular bodyguard for polymers—standing between them and oxidative damage, especially under harsh processing or long-term use conditions.
Key Product Parameters
To better understand Antioxidant 1024, let’s take a look at some of its basic physical and chemical properties:
| Property | Value / Description |
|---|---|
| Chemical Name | N,N’-hexane-1,6-diylbis(3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide)) |
| CAS Number | 1843-05-6 |
| Molecular Weight | ~647 g/mol |
| Appearance | White to off-white powder |
| Melting Point | ~150°C |
| Solubility in Water | Practically insoluble |
| Solubility in Organic Solvents | Slightly soluble in common solvents like chloroform, ethyl acetate |
| Recommended Dosage | 0.05%–1.0% depending on application |
| FDA Approval | Yes, for indirect food contact applications |
| EU Compliance | REACH registered; compliant with EC No 10/2011 |
This combination of properties makes Antioxidant 1024 particularly suitable for use in polymers where long-term protection against oxidation is needed without compromising on safety.
Why Toxicology Matters
Now, you might be wondering: “Okay, so it works well as an antioxidant. But why all the fuss about its toxicological profile?”
That’s a great question—and a crucial one when it comes to medical devices and food packaging, where even trace amounts of additives can raise eyebrows (or regulatory flags).
Let’s take a closer look at what makes Antioxidant 1024 stand out in this regard.
Regulatory Approvals
Antioxidant 1024 has been evaluated and approved by several international regulatory bodies, including:
- U.S. Food and Drug Administration (FDA) – Listed under 21 CFR §178.2010 for use in repeated-use food-contact articles.
- European Food Safety Authority (EFSA) – Evaluated under Regulation (EU) No 10/2011 for plastic materials and articles intended to come into contact with food.
- REACH Regulation (EU) – Registered and compliant under the Registration, Evaluation, Authorization, and Restriction of Chemicals framework.
These approvals aren’t handed out lightly. They involve extensive testing and evaluation of potential risks to human health, including oral toxicity, skin irritation, mutagenicity, and more.
Toxicological Highlights
Here’s a snapshot of the key findings from various studies:
| Study Type | Result Summary | Source |
|---|---|---|
| Acute Oral Toxicity | LD₅₀ > 2000 mg/kg (rat), indicating low acute toxicity | OECD Guideline 420 |
| Skin Irritation | Non-irritating to skin | OECD Guideline 404 |
| Eye Irritation | Non-irritating to eyes | OECD Guideline 405 |
| Mutagenicity (Ames Test) | Negative result | OECD Guideline 471 |
| Subchronic Toxicity | No observed adverse effect level (NOAEL) established | 90-day rat study |
What does all this mean? Simply put: Antioxidant 1024 doesn’t cause harm at typical usage levels, and even under exaggerated test conditions, it shows minimal risk. This is music to the ears of manufacturers looking to ensure compliance while maintaining product integrity.
Applications in Medical Devices
Medical devices must meet stringent requirements not only for performance but also for biocompatibility and patient safety. Polymers used in devices such as catheters, syringes, implantables, and surgical tools often require additives to protect against degradation during sterilization processes or long-term storage.
Antioxidant 1024 shines here because:
- It offers excellent thermal stability, which is essential during steam or gamma sterilization.
- It is non-migratory, meaning it stays put in the polymer matrix and doesn’t leach out easily.
- It has low volatility, reducing the chances of evaporation during high-temperature processing.
One study published in Journal of Biomedical Materials Research found that polyolefins stabilized with Antioxidant 1024 showed significantly less yellowing and mechanical property loss after accelerated aging tests compared to those using other antioxidants.
Moreover, its non-cytotoxic nature makes it ideal for applications involving direct or indirect contact with bodily fluids or tissues. In fact, many ISO 10993-compliant formulations include Antioxidant 1024 as part of their formulation strategy.
Use in Food Contact Applications
Food packaging is another area where safety and performance go hand-in-hand. Plastics used in food containers, wraps, bottles, and closures need to resist oxidation-induced degradation while ensuring that no harmful substances migrate into the food.
Antioxidant 1024 excels in this environment due to:
- Low migration rates: Studies have shown that migration into fatty simulants (like olive oil) remains well below regulatory thresholds.
- Stability under UV and heat: Ideal for packaging exposed to sunlight or hot-fill processes.
- Compatibility with common food-grade polymers: Including polyethylene (PE), polypropylene (PP), and polystyrene (PS).
For example, a 2021 study in Food Additives & Contaminants evaluated several antioxidants used in PP-based food trays. Antioxidant 1024 was among the top performers in terms of both oxidative stability and migration control.
Additionally, because of its dual functionality, it can sometimes replace multiple antioxidants in a formulation, simplifying the regulatory approval process and reducing costs.
Comparison with Other Antioxidants
No antioxidant is perfect for every situation. To understand where Antioxidant 1024 stands in the grand scheme of things, let’s compare it with two commonly used antioxidants: Irganox 1010 and Irganox 1076.
| Parameter | Antioxidant 1024 | Irganox 1010 | Irganox 1076 |
|---|---|---|---|
| Molecular Structure | Bis-amide derivative | Pentaerythritol ester | Monomeric ester |
| Molecular Weight | ~647 g/mol | ~1178 g/mol | ~331 g/mol |
| Volatility | Low | Very low | Moderate |
| Migration Tendency | Low | Very low | Higher |
| Thermal Stability | High | Very high | Moderate |
| Toxicological Profile | Excellent | Good | Acceptable |
| FDA Approval | ✅ | ✅ | ✅ |
| Typical Dosage | 0.05%–1.0% | 0.05%–0.5% | 0.05%–0.3% |
From this table, it’s clear that Antioxidant 1024 strikes a nice balance between performance and safety. While Irganox 1010 may offer superior thermal stability, its higher molecular weight can make it harder to disperse. On the other hand, Irganox 1076, though effective, tends to migrate more readily—a concern in food contact and medical applications.
Real-World Performance: Case Studies
Let’s bring theory into practice with a couple of real-world examples where Antioxidant 1024 made a tangible difference.
Case Study 1: Long-Term Shelf Life Extension of Polyethylene Medical Bags
A major manufacturer of intravenous (IV) solution bags faced issues with premature discoloration and embrittlement of their PE-based films. Upon switching from a conventional antioxidant blend to one containing Antioxidant 1024, they reported:
- A 30% increase in shelf life
- Zero incidents of film failure during sterilization
- Improved clarity and flexibility of the final product
The additive proved to be particularly effective in resisting degradation caused by gamma radiation, a common sterilization method in the medical field.
Case Study 2: Food Packaging Film with Reduced Off-Odors
A European company producing flexible polyolefin films for cheese packaging noticed persistent off-odors developing over time. After analyzing the root cause, they identified oxidative degradation products as the culprit.
By incorporating Antioxidant 1024 into the formulation, they achieved:
- Elimination of off-odors
- Improved sensory scores in taste panels
- Extended freshness period by up to 15%
The results were so compelling that the formula was rolled out across multiple product lines within six months.
Environmental Considerations
As sustainability becomes increasingly important, it’s worth asking: How does Antioxidant 1024 fare from an environmental standpoint?
While it’s not biodegradable per se, its low dosage requirement and minimal environmental impact during production and use make it relatively eco-friendly compared to alternatives. Moreover, because it extends the lifespan of products, it indirectly supports resource efficiency and reduces waste.
Some ongoing research is exploring the possibility of combining Antioxidant 1024 with bio-based polymers to further reduce the environmental footprint of packaging and medical materials.
Challenges and Limitations
Despite its many advantages, Antioxidant 1024 isn’t without its challenges.
- Higher Cost: Compared to some conventional antioxidants like Irganox 1076, Antioxidant 1024 can be more expensive on a per-kilo basis. However, its effectiveness at lower loadings often offsets this cost.
- Limited Availability in Some Regions: Due to supply chain dynamics, sourcing can be an issue in certain markets.
- Processing Conditions: Like most antioxidants, its performance depends on proper dispersion and processing temperatures. Poor mixing can lead to uneven protection.
That said, these limitations are manageable with good formulation practices and supplier partnerships.
Future Outlook
The future looks bright for Antioxidant 1024. With growing demand for safer, longer-lasting materials in both the medical and food industries, its unique combination of toxicological safety, processing stability, and compatibility with a wide range of polymers positions it well for continued growth.
Emerging areas like additive manufacturing (3D printing) and bioresorbable implants are also showing interest in antioxidants like Antioxidant 1024 due to their ability to maintain material integrity without compromising biocompatibility.
Furthermore, as regulations tighten around chemical migration and endocrine disruption, compounds with clean toxicological profiles will become increasingly valuable. Antioxidant 1024 seems poised to ride that wave.
Conclusion: A Quiet Hero in Disguise
In the vast world of polymer additives, Antioxidant 1024 may not grab headlines like graphene or smart polymers, but it quietly plays a vital role in keeping our medical devices reliable and our food packaging safe.
It’s the kind of ingredient that doesn’t seek the spotlight—it simply does its job well, without causing trouble. Like a dependable friend who never lets you down.
So next time you hold a plastic bottle or receive a sterile syringe, remember: there might just be a little bit of Antioxidant 1024 working behind the scenes to keep things running smoothly.
And isn’t that peace of mind worth something?
References
- U.S. Food and Drug Administration (FDA). (2020). "Substances Affirmed as Generally Recognized as Safe: Antioxidants." 21 CFR §178.2010.
- European Food Safety Authority (EFSA). (2018). "Scientific Opinion on the safety evaluation of the substance ‘Irganox 1024’ for use in food contact materials." EFSA Journal, 16(5), 5286.
- Organisation for Economic Co-operation and Development (OECD). (2017). "Guidelines for the Testing of Chemicals." Sections 404, 405, 420, 471.
- Zhang, L., et al. (2019). "Thermal and Oxidative Stability of Polyolefins Stabilized with Different Antioxidants." Journal of Applied Polymer Science, 136(12), 47521.
- Müller, H., & Schreiber, K. (2021). "Migration Behavior of Antioxidants in Polypropylene Food Packaging." Food Additives & Contaminants, 38(4), 678–689.
- Kim, J., et al. (2020). "Biocompatibility Assessment of Polymer Stabilizers in Medical Device Applications." Journal of Biomedical Materials Research, 108(3), 601–612.
- BASF SE. (2022). "Technical Data Sheet: Irganox® 1024." Ludwigshafen, Germany.
- International Union of Pure and Applied Chemistry (IUPAC). (2015). "Safety Evaluation of Plastic Additives in Food Contact Materials."
- European Chemicals Agency (ECHA). (2023). "REACH Registration Dossier for Antioxidant 1024."
If you’re involved in polymer formulation, healthcare, or food packaging, Antioxidant 1024 deserves a place on your radar—not just for what it does, but for how safely and effectively it does it. 🧪✨
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