High-Purity DINCH & ATBC: Safe Non-Phthalate Plasticizers for Medical and Food Applications
DOBO Technical R&D TeamUpdated 9 on Nov 2026Oct 28, 2026
How high-purity DINCH (CAS 166412-78-8) and ATBC (CAS 77-90-7) are specified for medical tubing, blood bags, food wrap, and toys: COA limits, migration testing, sterilization validation, and required documentation for regulated programs.
High-Purity DINCH & ATBC: Safe Non-Phthalate Plasticizers for Medical and Food Applications
Why do medical and food-contact programs prioritize purity over plasticizer cost?In these applications, plasticizers are evaluated based on what they do not release. Residual acidity, catalyst residues, color bodies, and volatile fractions that remain undetectable in a general PVC compound can become extractables, odors, or discoloration issues in tubing, blood bags, or food packaging films. DINCH (CAS 166412-78-8) and ATBC (CAS 77-90-7) are the two most commonly specified non-phthalate chemistries for this segment, selected for specification consistency rather than headline price.
What "high purity" actually means on a Certificate of Analysis
Purity in this segment isn't defined by a single assay value. A high-purity grade means a high assay alongside tightly controlled residual fractions that drive migration and odor, consistently across every batch.
| Parameter | Why It Matters for Medical and Food Contact Applications | Typical high-purity target |
|---|---|---|
| Assay / ester content | Determines the amount of non-plasticizing material present | ≥ 99.5% |
| Acid value | Residual acidity can catalyze degradation and increase extractables. | ≤ 0.05 mgKOH/g |
| Color (APHA) | Color bodies travel into transparent film and tubing | ≤ 30 |
| Volatility loss | Volatile components cause odors and fogging. | ≤ 0.20% |
| Water content | Moisture impacts clarity and processing stability. | ≤ 0.10% |
| Batch-to-batch variation | Consistency of the final product | Narrow, batch-specific documentation |
The last row is what buyers often overlook. A supplier that meets specifications once isn't the same as one whose fifth batch performs like the first. In a validated medical process, only the latter is truly useful.
DINCH: the cyclohexane dicarboxylate pathway
DINCH is diisononyl cyclohexane-1,2-dicarboxylate, CAS 166412-78-8. Unlike phthalates, DINCH is a cyclohexane dicarboxylate with low migration and low volatility, making it ideal for PVC medical tubing, blood bags, infusion sets, children's toys, and food wrap film. Its compatibility with PVC closely matches the phthalates it replaces, requiring only minor processing adjustments during conversion. This efficiency has made DINCH the default non-phthalate choice for medical programs needing rapid transition.
Two practical considerations shape this specification. First, migration performance depends on the plasticizer's interaction with PVC and the part's surface-to-volume ratio; therefore, a thin film and a thick tube made from the same compound will not behave identically and must be tested separately. Second, the sterilization method matters: gamma irradiation, ethylene oxide, and steam each stress the formulation differently, so the plasticizer selection must be validated against the specific method used.
ATBC: the citrate route
ATBC is acetyl tributyl citrate, CAS 77-90-7. It is a citrate ester with an established toxicological profile and excellent clarity. Widely used in food packaging films, toys, baby products, medical flexible goods, and adhesives and coatings where a non-phthalate plasticizer is required. Compared to DINCH, ATBC is generally more volatile and less permanent, making it better suited for thin films, short-life applications, and processes with moderate temperatures. It is less suitable for thick sections exposed to sustained heat.
The practical choice isn't which chemistry is "better," but which failure mode the application can tolerate: for long-contact medical devices, migration and extraction point to DINCH; for thin food packaging films, cost and clarity favor ATBC.
Comparing the two against a phthalate baseline
| Dimensions | DINCH | ATBC | DOP (for reference only) |
|---|---|---|---|
| Chemistry | Cyclohexane dicarboxylate | Citrate ester | Orthophthalate |
| Migration direction | Low | Low to moderate | Higher |
| Volatility direction | Low | Moderate | Moderate |
| Clarity and color | Good | Good | Good |
| Processing window | Near phthalates | Slightly narrower | Wide |
| Regular fit | Medical tubing, bags, toys, and food wrap | Food packaging films, toys, infant products, adhesives | General industrial PVC |
The table is a screening tool, not a qualification. Regulatory status depends on the article, the market, and the migration test actually performed on the finished product.
Qualification path for a regulated product
| Step | Activity | Output |
|---|---|---|
| 1 | Define article, contact type, and market | Target regulation list and test matrix |
| 2 | Request sample and batch COA | Verify specifications against target limits |
| 3 | Load test at intended capacity | Hardness, clarity, processing behavior |
| 4 | Migration or extraction testing, as applicable | Compliance evidence for the article |
| 5 | Sterilization or Service Simulation | Confirm that the article survives its process |
| 6 | Validation batches and batch-to-batch review | Release documentation consistency |
Steps 4 to 6 are where programs typically slow down and reveal a supplier's documentation discipline. A complete package should include a per-batch COA, an MSDS, and a clear statement of the regulatory standard the grade complies with, along with referenced test reports rather than summaries.
Documentation required before the first order
- Per-batch certificate of analysis with the parameters listed above
- Safety Data Sheet in the receiving site's language
- Composition Statement and Non-Phthalate Confirmation
- Migration or extraction test direction available for the specified contact type
- Packaging and shelf-life information, including drum, IBC, and Flexitank options
Frequently asked questions
No, DINCH is not a phthalate. It is a non-phthalate plasticizer used as an alternative to traditional phthalates in PVC products.No. DINCH is a cyclohexane dicarboxylate, distinct from ortho-phthalates like DOP.
Can ATBC and DINCH be blended?They are compatible in many PVC systems. Blending is sometimes used to balance cost against permanence, but the blend must be qualified as its own formulation rather than assumed from the two components.
Does food-contact grade certification guarantee approval in every market?Approval applies to the finished product and the specific test conducted; the grade provides the initial evidence.
What sample sizes are available?A 1kg complimentary sample is shipped for lab evaluation. Trial order MOQ is 1 MT; bulk shipments use 23 MT flexitank containers from Ningbo or Shanghai.
Next
Provide the article type, contact category, sterilization method, and target market. Our technical team will recommend the appropriate grade pathway and documentation set for your qualification file. The statements here indicate selection directions; compliance is verified via the finished product test report and batch COA.
Related grade
ATBC · ATBC Acetyl Tributyl Citrate (Food-Contact Guidelines)
CAS77-90-7
Regulatory and standards references
The links below lead to official EU, US, and ISO sources for the compliance frameworks discussed on this page. DOBO does not control third-party content; the official text and regulations of the buyer's market take precedence.
- ECHA — Understanding REACHEU registration, evaluation, authorisation and restriction of chemicals (REACH), including the Candidate List of substances of very high concern.
- EUR-Lex — Directive 2011/65/EU (RoHS 2)Restriction on the use of certain hazardous substances in electrical and electronic equipment; Annex II lists restricted substances and their maximum concentrations.
- eCFR — 21 CFR 175.300US FDA regulations for resinous and polymeric coatings intended for repeated use as food-contact surfaces, including extraction testing conditions.
- ASTM — Plastic and plasticizer standardsASTM International publishes the test methods referenced in our TDS, including plasticizer sampling and chemical analysis, tensile properties, and heat-aging procedures.
- ASTM — Plastic and Plasticizer Testing StandardsASTM International has published the test methods referenced in the TDS, covering sampling and chemical analysis of plasticizers, as well as tensile properties and thermal aging procedures.
- ISO — ISO 10993-1Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process, establishing the foundation for biocompatibility programs.
Request a 1 kg Free Sample & Full COA/TDS
Test ATBC in your own formulation. The request below is pre-filled with the grade discussed in this whitepaper, along with the specification, documentation, and sample shipping confirmation.
Related technical reading
- Medical-Grade DINCH vs. DOP/DEHP Safety Review (EN 71-3 & FDA Compliance)Contact-safety assessment of ultra-pure DINCH (CAS 166412-78-8) for medical, toy, and food-contact PVC: migration behavior, biocompatibility testing guidance, and required documentation.
- ESBO Synergistic Heat Stabilization for Rigid and Soft PVCHow epoxidized soybean oil works with Ca/Zn stabilizers in flexible PVC: HCl scavenging, zinc burn control, typical 3-7 phr dosage ranges, and processing checks.
- ATBC Bio-Based Non-Toxic Plasticizer for Food WrapATBC Citrate Ester (CAS 77-90-7) for Food Wrap: Bio-Based Chemistry, Migration Risks in Thin Films, Comparison with DINCH and ESBO, and How Food-Contact Regulations Guide Selection