MYRISTYL ALCOHOL
MYRISTYL ALCOHOL (CAS 112-72-1) is a saturated fatty alcohol used primarily as a formulation aid such as a lubricant or release agent in industrial and indirect food contact applications. It is present on the FDA inventory of indirect food additives authorized under various food contact substance provisions. The compound is a long-chain fatty alcohol with low volatility and minimal solubility in water, typical of C14 fatty alcohols used across industrial formulations.
What It Is
MYRISTYL ALCOHOL is a long-chain saturated fatty alcohol with the chemical designation tetradecan-1-ol and molecular formula C14H30O. It belongs to the class of fatty alcohols which are aliphatic alcohols derived from the reduction of fatty acids. These types of substances are characterized by a straight hydrocarbon chain with a terminal hydroxyl group, conferring amphiphilic properties that make them useful in formulation and surface-active applications. The specific CAS Registry Number for MYRISTYL ALCOHOL is 112-72-1, which allows for unambiguous identification of the compound across scientific, regulatory, and industrial contexts. This compound is known by a variety of other names including tetradecyl alcohol, 1-tetradecanol, C14 alcohol, fatty alcohol (C14), and 1-hydroxytetradecane. These synonyms may appear in technical specifications, safety data sheets, or chemical inventories. In its pure form, MYRISTYL ALCOHOL typically appears as a waxy, white solid with physical properties consistent with long-chain alcohols, such as a relatively high melting and boiling point compared to shorter-chain alcohols. As a member of the saturated fatty alcohols, it is non-volatile under typical ambient conditions and exhibits very low water solubility. These characteristics influence how it behaves in formulations and why it is selected for specific technical functions.
How It Is Made
The production of MYRISTYL ALCOHOL generally involves the reduction of the corresponding fatty acid or its derivatives. In commercial practice, the process begins with myristic acid, a 14-carbon saturated fatty acid which can be obtained from natural sources like nutmeg butter or coconut oil, or synthesized from petrochemical feedstocks. The fatty acid is then subjected to a catalytic hydrogenation process where a catalyst such as nickel is used under elevated temperature and pressure to reduce the carboxylic acid group to a primary alcohol. This hydrogenation step replaces the carbonyl group of the fatty acid with a hydroxyl group, yielding the fatty alcohol. After this chemical transformation, the reaction mixture is typically purified through distillation and other refining steps to achieve the desired purity level. Commercial grades of MYRISTYL ALCOHOL may vary in purity, and specifications commonly define the minimum content of the primary alcohol alongside acceptable levels of residual impurities. In addition to hydrogenation, alternative synthesis approaches may include hydroformylation of shorter-chain olefins followed by hydrogenation, or other chemical routes that yield the long-chain alcohol structure. Once manufactured, the product is typically marketed and distributed as solid flakes, beads, or wax-like pellets to facilitate handling and incorporation into industrial processes.
Why It Is Used In Food
MYRISTYL ALCOHOL is included in certain indirect food additive regulations primarily because of its role in food contact materials and processing aids rather than as a direct additive to food products. In such contexts, the compound provides technical functionality, such as acting as a lubricant, release agent, or formulation aid in the manufacture of packaging materials or food processing equipment. These applications rely on the compound’s physical and chemical properties, particularly its low volatility and high melting point which make it suitable for imparting surface properties to polymers or coatings. In the food industry, indirect additives like MYRISTYL ALCOHOL are used to ensure that food does not stick to processing equipment or packaging surfaces during production, filling, or storage. For example, when incorporated into polymeric materials, the fatty alcohol can migrate to the material surface and reduce friction, thereby improving the efficiency of processing lines or the ease of release of food products. Its function as a lubricant or release agent is technical in nature and not intended to modify the nutritional or sensory attributes of food. This technical rationale underpins regulatory frameworks which authorize such compounds for specified food contact uses with defined conditions. The specific FDA regulatory references d in the inventory listing reflect these allowable uses. The inclusion on the FDA inventory indicates that MYRISTYL ALCOHOL has been evaluated for these indirect uses and is permitted under the relevant sections of the CFR for food contact materials.
Adi Example Calculation
To illustrate how ADI concepts might apply in a food contact context, consider a hypothetical scenario where a compound has an ADI of 1 mg/kg bw/day. For an individual weighing 70 kilograms, the hypothetical ADI would be 70 mg per day. If migration from a food contact material to food were estimated at 0.1 mg per day for that individual, the exposure would be well below the hypothetical ADI and thus considered within a safe range. In this example, it is crucial to emphasize that the numeric values are illustrative and not based on an established ADI for MYRISTYL ALCOHOL. Regulatory decisions regarding indirect food additives often hinge on migration studies, exposure assessments, and safety factors rather than direct calculation of daily intake because the expected exposure through migration is typically minimal.
Safety And Health Research
Safety assessments of chemical substances used in food contact applications are generally focused on evaluating the potential for migration from materials to food and the associated exposure levels. For substances like MYRISTYL ALCOHOL that function as formulation aids or release agents, toxicological data often include acute toxicity studies, dermal irritation profiles, and assessments of systemic toxicity at relevant exposure levels. Regulatory inventories like the FDA’s list of indirect food additives provide a means to ensure that substances with appropriate safety profiles and technical justification are permitted for intended uses under defined conditions. Studies on the toxicological profile of MYRISTYL ALCOHOL indicate that it has relatively low acute toxicity when administered in high doses in laboratory animals, as suggested by historical oral LD50 values reported in toxicology databases. These observations are consistent with other long-chain fatty alcohols which are generally considered to have low systemic toxicity at typical exposure levels. Nevertheless, comprehensive safety assessments consider a range of endpoints such as genotoxicity, chronic toxicity, reproductive and developmental toxicity, and potential for irritation or sensitization. For food contact substances, regulators focus on the potential for incidental ingestion through migration and whether the exposure would remain below levels of concern. It is important to note that safety evaluations incorporated into regulatory decisions are based on the best available scientific evidence, and ongoing research may lead to updates or revisions in authorization status. In contexts such as cosmetic ingredient safety assessments, panels may review data on irritation and sensitization but these evaluations are specific to that use case rather than food contact. Overall, the safety profile of MYRISTYL ALCOHOL in authorized indirect food applications is managed through regulatory frameworks that aim to ensure that incidental exposure remains within safe limits.
Regulatory Status Worldwide
MYRISTYL ALCOHOL is listed in the FDA’s inventory of indirect food additives that are authorized for use in food contact substances under various sections of the Code of Federal Regulations. The inventory specifies that this substance is recognized under the relevant parts of 21 CFR including provisions for formulation aids, lubricants, and release agents when used in accordance with good manufacturing practice and under specified conditions. The specific CFR sections d in the FDA inventory listing provide the regulatory framework for these authorized uses. These sections cover indirect additives such as food contact substances that may migrate into food under controlled conditions. The presence of MYRISTYL ALCOHOL in these inventories indicates that the regulatory authority has evaluated its technical function and potential for incidental exposure through contact with food. In other jurisdictions such as the European Union, regulatory evaluation of substances used as indirect food additives or flavoring agents may follow separate authorization processes. For example, the European Food Safety Authority (EFSA) conducts safety assessments of food flavorings and additives when they are submitted for authorization or re-evaluation. The EFSA Panel on Food Additives and Flavourings regularly reviews scientific data to determine whether such substances present risks under proposed conditions of use. The regulatory framework in the EU includes Regulation EC 1331/2008 which establishes the procedures for authorizing food additives and flavorings. While MYRISTYL ALCOHOL may be evaluated for certain indirect applications, specific authorization status in the EU for this compound as an indirect food contact additive would depend on the completion of a formal application and scientific assessment. Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) maintains a database of evaluations of food additives and contaminants which can include information on safety assessments and acceptable uses. Whether MYRISTYL ALCOHOL has been evaluated by JECFA specifically for food contact applications would require confirmation through the WHO JECFA database. At present, in the absence of a specific JECFA evaluation record linked to this compound, regulatory safety assessments remain grounded in national or regional frameworks such as the FDA inventory.
Taste And Functional Properties
MYRISTYL ALCOHOL itself is not used as a flavoring agent or a direct food ingredient, and as such does not contribute a taste profile to foods at the low levels associated with its food contact applications. The compound’s sensory impact is minimal in the context of food contact because it is present on material surfaces rather than incorporated into the food matrix as an additive. In formulation science outside of food contact, long-chain fatty alcohols such as this can impart a waxy or fatty mouthfeel when present at higher concentrations in certain products, but this is distinct from its indirect use in food contact. Functionally, MYRISTYL ALCOHOL exhibits properties typical of long-chain alcohols. It has very low water solubility and high melting and boiling points compared to shorter-chain alcohols, which influence how it behaves in formulations. Its long hydrocarbon chain confers hydrophobic properties that make it effective at modifying surface characteristics when blended with polymers or surfactant systems. It can contribute to increased viscosity, improved texture in certain cosmetic formulations, and enhanced stability of emulsions when used in non-food products. In the context of its authorized uses, these physical and functional properties provide benefits for reducing friction, improving release from surfaces, and stabilizing formulations without directly affecting the sensory attributes of food.
Acceptable Daily Intake Explained
An Acceptable Daily Intake (ADI) is a concept used by food safety authorities to describe the maximum amount of a substance that can be consumed daily over a lifetime without appreciable health risk. ADIs are typically derived from toxicological studies in animals, applying safety factors to account for differences between animals and humans and variations within human populations. For indirect food additives like MYRISTYL ALCOHOL, which are used in food contact materials, the focus is often more on ensuring that migration to food remains minimal rather than establishing a numeric ADI. In cases where a regulatory body such as JECFA or EFSA has not established a specific ADI for a substance, safety assessment centers on exposure estimates and whether incidental contact would be negligible. When an ADI is provided by a regulatory authority, it is usually expressed in milligrams of substance per kilogram of body weight per day (mg/kg bw/day). This number represents a level of exposure that is expected to pose no significant risk over a lifetime. It is important to emphasize that an ADI is not a recommended intake, but rather a safety benchmark. For substances used indirectly where migration to food is low, the pragmatic goal of regulatory oversight is to ensure that any potential exposure through food contact does not exceed conservative safety thresholds. In the absence of a formally established ADI for MYRISTYL ALCOHOL, safety frameworks rely on data showing low toxicity at relevant exposure levels and conditions of authorized use.
Comparison With Similar Additives
MYRISTYL ALCOHOL shares functional similarities with other long-chain fatty alcohols such as STEARYL ALCOHOL (C18) and CETYL ALCOHOL (C16). These compounds are also used as formulation aids, lubricants, and emollients in industrial and personal care applications. Like MYRISTYL ALCOHOL, STEARYL ALCOHOL and CETYL ALCOHOL have low water solubility, high melting points, and are used to modify surface properties or enhance texture in various formulations. In food contact applications, these fatty alcohols may be included in indirect additive lists when they perform similar technical functions such as acting as slip agents or release aids in packaging materials. Compared to shorter-chain alcohols such as LAURYL ALCOHOL (C12), the longer carbon chain of MYRISTYL ALCOHOL imparts greater hydrophobicity and different physical properties that can influence how it interacts with polymer matrices or surfaces. These differences in chain length can affect melting point, viscosity, and how readily the alcohol migrates to surfaces. In regulatory contexts, each fatty alcohol must be assessed on its own merits, considering its specific physical properties and potential for migration. Despite these differences, the broader category of long-chain fatty alcohols tends to exhibit low systemic toxicity and similar functional roles in formulation science.
Common Food Applications Narrative
When considering the role of MYRISTYL ALCOHOL in food-related contexts, it is important to understand that the compound is not added directly to foods as a flavor enhancer, preservative, or nutrient. Instead, its applications are tied to the equipment, processes, and materials that come into contact with food during production, packaging, or storage. For instance, the manufacturing of polymer films, coatings, or processing surfaces may utilize MYRISTYL ALCOHOL to help ensure that food items do not adhere to machinery or packaging surfaces. This can be critical in high-speed processing environments where sticking or friction could lead to product loss, contamination, or damage to equipment. Examples of where this type of compound is relevant include the production of baking trays and conveyor belts, where a release aid can facilitate the movement of dough, baked goods, or other food items without sticking. Similarly, food packaging films may incorporate fatty alcohols into their surface layers to help reduce static or improve slip, which can assist in automated packaging lines. In all these scenarios, the compound’s technical role is associated with the engineering and performance of food contact materials rather than any direct contribution to food composition. This narrative aligns with how regulatory frameworks classify and authorize such substances, focusing on the safety of contact and migration from materials rather than direct ingestion at significant levels. By controlling and limiting the ways in which MYRISTYL ALCOHOL may be used in food contact applications, regulators aim to ensure that any incidental exposure remains low and safe within established food safety principles.
Safety & Regulations
FDA
- Notes: FDA inventory listing indicates authorized use as an indirect food additive under multiple CFR sections but specific numeric criteria were not confirmed in the linked source.
EFSA
- Notes: No specific EFSA ADI or approval detail for this compound as a food additive was found in the d sources.
JECFA
- Notes: No JECFA evaluation with numeric ADI or INS number was identified in the WHO JECFA database.
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