Antioxidant 245 for food contact and sensitive medical applications due to its excellent toxicological profile

2025-06-30by admin

Antioxidant 245: A Safe and Versatile Protector for Food Contact and Medical Applications

In the world of modern materials science, antioxidants play a crucial role in preserving the integrity and longevity of polymers. Among them, Antioxidant 245, also known as Irganox 245, has carved out a niche for itself—not just because of its performance, but because of its safety profile, which makes it ideal for use in food contact applications and even in sensitive medical devices.

If you’ve ever wondered how your plastic water bottle doesn’t taste like old socks or why your IV drip tubing doesn’t degrade under UV light, chances are Antioxidant 245 is quietly working behind the scenes. Let’s dive into what makes this compound so special, why it’s trusted in high-stakes environments, and how it compares to other antioxidants on the market.


🌟 What Exactly Is Antioxidant 245?

Antioxidant 245, chemically known as Pentaerythrityl tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate), belongs to the family of hindered phenolic antioxidants. These compounds act by scavenging free radicals—those pesky little molecules that cause oxidative degradation in plastics, leading to discoloration, brittleness, and reduced lifespan.

Think of Antioxidant 245 as a bodyguard for polymers. It intercepts the troublemakers before they can wreak havoc, ensuring that the material remains stable, flexible, and safe—even when exposed to heat, oxygen, or UV radiation.


⚙️ Key Technical Parameters

Let’s take a look at some of the key physical and chemical properties of Antioxidant 245:

Property Value
Chemical Name Pentaerythrityl tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)
Molecular Weight ~1114 g/mol
Appearance White to off-white powder or granules
Melting Point 70–80°C
Density ~1.15 g/cm³
Solubility in Water Practically insoluble
Solubility in Common Solvents Soluble in organic solvents (e.g., acetone, toluene)
Recommended Dosage 0.05–1.0% depending on application
Regulatory Status FDA approved (US), EU 10/2011 compliant

These parameters make Antioxidant 245 particularly suitable for incorporation into polyolefins, polyurethanes, and thermoplastic elastomers—materials commonly used in food packaging and medical devices.


🍽️ Why Use Antioxidant 245 in Food Contact Materials?

Food safety is no joke. When we store food in plastic containers, drink from bottles, or wrap sandwiches in cling film, we trust that those materials won’t leach harmful chemicals into our meals. That’s where regulatory compliance comes in—and Antioxidant 245 shines here.

✅ FDA Approval & EU Compliance

Antioxidant 245 is listed under the U.S. Food and Drug Administration (FDA) regulations in 21 CFR §178.2010, allowing its use in food-contact polymers. In the European Union, it complies with Regulation (EU) No 10/2011, which governs plastic materials and articles intended to come into contact with foodstuffs.

This means that even if the antioxidant migrates slightly into food (as all additives do to some extent), it does so within strictly defined limits that pose no health risk to consumers.

🧪 Toxicological Profile

One of the standout features of Antioxidant 245 is its low toxicity. According to studies conducted by the European Food Safety Authority (EFSA), long-term exposure to low doses of this antioxidant does not result in adverse effects such as endocrine disruption, carcinogenicity, or developmental toxicity.

Here’s a summary of its toxicological data based on animal studies:

Study Type NOAEL (mg/kg/day) Notes
Acute Oral Toxicity >2000 Non-toxic
Subchronic Toxicity 500 No observed adverse effect level
Reproductive Toxicity 250 No significant impact detected
Genotoxicity Negative results No DNA damage observed

Source: EFSA Journal (2019); BASF Product Safety Data Sheet


🏥 Sensitive Medical Applications: Can Plastics Be Trusted?

When it comes to healthcare, especially devices that come into direct contact with the human body—like catheters, syringes, or dialysis tubes—the stakes are sky-high. Any leaching of harmful substances could lead to serious complications.

That’s why materials used in these contexts must pass rigorous biocompatibility tests, often following ISO 10993 standards. And guess what? Antioxidant 245 has been shown to meet these requirements with flying colors.

🧬 Biocompatibility Testing Results

Test Type Result Standard Used
Cytotoxicity Pass ISO 10993-5
Sensitization Pass ISO 10993-10
Irritation Pass ISO 10993-10
Systemic Toxicity Pass ISO 10993-11
Genotoxicity (Ames test) Negative OECD Guideline 471

Source: Medical Device Materials II, Elsevier (2006)

These findings support the use of Antioxidant 245 in medical-grade polymers, especially those used in short- to medium-term implants or disposable devices.


🔬 Mechanism of Action: How Does It Work?

To understand why Antioxidant 245 is so effective, let’s take a peek inside the molecular machinery of polymer oxidation.

Polymers, especially polyolefins like polyethylene and polypropylene, are prone to autoxidation—a process initiated by heat, light, or metal ions. This leads to the formation of reactive free radicals, which then trigger a chain reaction of oxidative breakdown.

Antioxidant 245 works by donating hydrogen atoms to these free radicals, effectively neutralizing them before they can propagate further damage. Because of its four hindered phenol groups, each molecule can quench multiple radicals, making it highly efficient compared to single-function antioxidants.

In layman’s terms: one Antioxidant 245 molecule is like four tiny soldiers standing guard over your plastic, ready to disarm any threats that come knocking.


📊 Comparing Antioxidant 245 with Other Common Antioxidants

How does Antioxidant 245 stack up against its peers? Here’s a side-by-side comparison with two widely used antioxidants: Irganox 1010 and Irganox 1076.

Feature Antioxidant 245 Irganox 1010 Irganox 1076
Molecular Structure Tetrafunctional Tetrafunctional Monofunctional
Molecular Weight ~1114 g/mol ~1178 g/mol ~533 g/mol
Volatility Low Moderate High
Migration Tendency Very low Moderate High
Regulatory Approvals FDA, EU 10/2011 FDA, EU FDA, EU
Cost Moderate High Low
Suitability for Food/Medical Use Excellent Good Limited due to migration

As seen above, while Irganox 1010 offers similar protection, its higher cost and moderate volatility make Antioxidant 245 a more practical choice for sensitive applications. Meanwhile, Irganox 1076, though cheaper, tends to migrate more easily, making it less desirable in regulated environments.


🛠️ Application Examples

Now that we know how good Antioxidant 245 is, let’s see where it actually gets used.

🥤 Beverage Bottles

Polyethylene terephthalate (PET) bottles used for soft drinks, juices, and water benefit greatly from the addition of Antioxidant 245. It prevents yellowing and maintains clarity, ensuring that your lemonade stays looking fresh and clean.

🧴 Cosmetic Packaging

From shampoo bottles to moisturizer jars, cosmetic packaging demands both aesthetics and safety. Antioxidant 245 ensures that the packaging doesn’t degrade under sunlight or during storage, without compromising skin safety.

💉 Medical Tubing

Flexible PVC or thermoplastic elastomer tubing used in hospitals often contains this antioxidant to prevent embrittlement and maintain flexibility, even after sterilization processes like gamma irradiation.

🥫 Food Packaging Films

Flexible films made from polyethylene or polypropylene that wrap everything from cheese to frozen dinners rely on Antioxidant 245 to stay strong and odor-free.


🧪 Stability Under Sterilization Conditions

Sterilization is a necessary evil in the medical world. But it’s harsh on materials. Processes like autoclaving, gamma irradiation, and ethylene oxide treatment can accelerate oxidative degradation.

Thankfully, Antioxidant 245 holds up well under these conditions. Studies have shown that medical-grade polypropylene compounded with this antioxidant retains its mechanical strength and color stability even after multiple sterilization cycles.

One study published in Radiation Physics and Chemistry (2014) demonstrated that samples containing Antioxidant 245 showed significantly less yellowing and retained more than 90% of their original tensile strength after gamma irradiation, compared to unmodified controls.


🌱 Environmental Considerations

With increasing emphasis on sustainability, it’s worth asking: how eco-friendly is Antioxidant 245?

While it is not biodegradable in the traditional sense, it has a low aquatic toxicity profile, meaning it doesn’t pose a major threat to marine life if it ends up in waterways. Furthermore, because it is used in small quantities and remains bound within the polymer matrix, environmental release is minimal.

Some researchers are exploring ways to recover and recycle polymers containing antioxidants like 245, although this is still an emerging area of research.


🧑‍🔬 Future Outlook

The future looks bright for Antioxidant 245. As global demand for safer, longer-lasting plastics continues to rise—especially in the food and medical sectors—this antioxidant will likely remain a go-to additive.

Ongoing research includes optimizing its compatibility with bio-based polymers and enhancing its performance under extreme conditions. For instance, companies like BASF and Clariant are investing in next-generation formulations that combine Antioxidant 245 with UV stabilizers or anti-microbial agents for multi-functional protection.


🧾 Summary Table: Why Choose Antioxidant 245?

Reason Explanation
Regulatory Compliance Approved by FDA and EU for food and medical use
Low Migration Minimal leaching into food or bodily fluids
Excellent Toxicological Profile Non-carcinogenic, non-mutagenic, non-endocrine disrupting
Strong Oxidative Protection Multi-functional structure provides robust defense against free radicals
Compatibility with Polymers Works well with polyolefins, polyurethanes, and thermoplastics
Stability During Sterilization Maintains integrity after gamma, ethylene oxide, and autoclave treatments
Cost-Effective Offers good value compared to alternatives

🧠 Final Thoughts

In a world increasingly concerned with safety, transparency, and performance, Antioxidant 245 stands out as a quiet hero. It may not be glamorous, but it’s reliable, versatile, and essential for keeping our food safe and our medical devices functional.

So the next time you sip from a plastic bottle or watch a nurse hook up an IV line, remember there’s a little antioxidant doing a big job behind the scenes—keeping things fresh, safe, and intact.

After all, isn’t it comforting to know that sometimes, the best heroes wear lab coats instead of capes?


📚 References

  1. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). (2019). "Safety evaluation of pentaerythrityl tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)." EFSA Journal, 17(1), e05589.

  2. BASF SE. (2021). Product Safety Data Sheet – Antioxidant 245. Ludwigshafen, Germany.

  3. ISO 10993-1:2018. Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

  4. Radiat Phys Chem. (2014). “Effect of antioxidants on gamma irradiated polypropylene.” Radiation Physics and Chemistry, 104, 142–147.

  5. Lutz, M.F., et al. (2006). Medical Device Materials II: Proceedings of the 2nd International Symposium. Elsevier.

  6. European Commission. (2011). Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

  7. U.S. Food and Drug Administration. (2020). Code of Federal Regulations Title 21, Section 178.2010 – Antioxidants.


If you found this article informative and engaging, feel free to share it with fellow material scientists, packaging engineers, or anyone curious about the unsung heroes of polymer chemistry!

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