You may find that this adhesive makes your hands feel sticky or slippery after use. It is manufactured reacting partially depolymerised cellulose with methyl groups and containing a small degree of hydroxypropyl substitution (Figure11). In the absence of data, the FEEDAP Panelis not in the position to conclude on the safety of HPMC for the user. The EFSA ANS Panel(2018) concluded that modified celluloses including ethyl and methyl, hydroxypropyl celluloses, would not be absorbed intact and not fermented in the gastrointestinal tract of animals (rat) or humans; they are excreted essentially unchanged mainly via the faeces (more than 90% of the administrated doses), while only minor amounts of metabolites and derivedproducts are excreted via urine or expired air (as 14CO2) and there is no indication for accumulation in the body. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. National Library of Medicine Moreover, the extent of cellulose digestion is a compromise between the rate of hydrolysis and the retention time in the rumen related to the particle size of the forage. Epub 2008 Feb 13. (EFSA Panelon Additives and Products or Substances used in Animal Feed), 2012b. The main findings of the studies evaluated in the previous assessments, in particular in the ANS Panelopinion (EFSA ANS Panel, 2018) are summarised below. There are many fields of application for hypromellose, including:[5]. Substitution of cellulose with ethyl, methyl, hydroxypropyl, hydroxypropylmethyl and carboxymethyl groups may increase the resistance of cellulose to degradation. 8600 Rockville Pike They were looking for a substance that would be able to bind the ingredients inside of medicine capsules together without breaking down too quickly. 2011 Jan 26;59(2):741-6. doi: 10.1021/jf103817h. Moreover, the FEEDAP Panelalso noted that methyl cellulose and carboxymethyl cellulose have been used for a long time as vehicles for nonwatersoluble substances in several invivo genotoxicity assays and are recommended for this use by the current OECD test guidelines (e.g. Unauthorized use of these marks is strictly prohibited. HPMC is [3] Its Codex Alimentarius code (E number) is E464. That is, the higher the concentration of the methoxy group, the lower the critical temperature. FOIA Data on chronic toxicity and carcinogenicity are available for microcrystalline cellulose (E 460), methyl cellulose (E 461) hydroxypropyl cellulose (E 463), HPMC (E 464) and sodium carboxymethyl cellulose (E 466). If your symptoms or health problems do not get better or if they become worse, call your doctor. 4,500mg/kg bw (for mixture with guar gum) and 4,600mg/kg bw (for mixture with sodium carboxymethyl cellulose). Product and Company Identification Product Name Hydroxypropyl Methylcellulose CAS Number 9004-65-3 Parchem - fine & specialty chemicals 415 Huguenot Street New Rochelle, NY 10801 (914) 654-6800 (914) 654-6899 parchem.com info@parchem.com Ophthalmology, 90 (1983 . In addition, some suppliers refer to methyl cellulose as the common name for hydroxypropyl methyl cellulose (HPMC) and Hydroxyethyl methyl cellulose (HEMC). For all examined parameters, no adverse effects were reported and also the observed tumours did not differ in type and number in treated and control groups. This use is petitioned as an alternative to gelatin (animal based) capsules. The following steps are involved in this process: Hydroxypropyl Methylcellulose was first discovered in the 1950s by scientists at Dow Chemical Company. Hydroxypropyl Methylcellulose - Memorial Sloan Kettering Cancer Center For microcrystalline cellulose (E 460) the identified NOAELs in rats ranged from 3,769mg/kg body weight (bw) per day to 9,000mg/kg bw per day and in all cases corresponded to the highest levels of the test substance. This includes both food and cosmetics. HPMC can be difficult to remove from formulations. Overall, the data set for genotoxicity is not complete for all the substances and several studies were not in line with the current standard. HPMC is a water-soluble polymer made from cellulose modified with hydroxypropyl groups. Check with your Developing Core/Shell Capsules Based on Hydroxypropyl Methylcellulose and Gelatin through Electrodynamic Atomization for Betalain Encapsulation. Hydroxypropyl methyl cellulose is authorised to be used as a food additive in accordance with Annex II to Regulation (EC) No(1333/2008)3 with specific purity criteria defined in Commission Regulation (EU) No231/2012.4. Goniosol, Goniotaire, Goniovisc, ImproVue, Isopto Tears, Natural Balance Tears, Natures Tears, OcuCoat Viscoadherent, Pure & Gentle Lubricant, Systane Overnight Therapy. Methyl cellulose and HPMC are two types of cellulose-based polymers commonly used in building materials. Synonyms: Hydroxypropyl Methylcellulose; Propylene Glycol Ether of Methylcellulose; Modified Cellulose; HPMC; Hypromellose Substitution type 2910 4000 mPa s CAS #: 9004-65-3 . ), Viscometer spindle number (1 ~ 4 for Brookfield LV, 1 ~ 7 for Brookfield RV, etc. The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature. The NOAEL for both maternal and developmental toxicity were the highest experimental dosages, i.e. [11] Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The FEEDAP Panelconcluded that hydroxypropyl methyl cellulose is considered safe for all animal species. Scientific Opinion on DLmethionine, DLmethionine sodium salt, the hydroxy analogue of methionine and the calcium salt of methionine hydroxy analogue in all animal species; on the isopropyl ester of methionine hydroxy analogue and DLmethionine technically pure protected with copolymer vinylpyridine/styrene in dairy cows; and on DLmethionine technically pure protected with ethylcellulose in ruminants. The other ingredients in this group are all modified cellulose polymers. Hydroxypropyl Methylcellulose Global Market Report 2023 - GlobeNewswire It can be used in products that need to be clear, or it can be used to add opacity. Some of these drugs need to be shaken before use. (Joint FAO/WHO Expert Committee on Food Additives), 1990. Based on the above results, a NOAEL of 285mg methyl cellulose (E 461) mg/kg bw per day could be identified in rats. Safety and efficacy of hydroxypropyl methyl cellulose for all animal HPMC is widely used in the food, pharmaceutical, and cosmetics industries. On the other side, animals with large fermentation chambers in the intestine, such as ruminants, horses and rabbits, utilise large amounts of cellulose as energy source. FDA (U.S. Food and Drug Administration). It can irritate you if it gets into your eyes or skin. NLM (National Library of Medicine). In particular, Article 10(2) of that Regulation also specifies that for existing products within the meaning of Article 10(1), an application shall be submitted in accordance with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of seven years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC. Marine and freshwater fish harbour an intestinal microbiota less abundant than in mammals, made of aerobic and facultative anaerobic bacteria. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on hydroxypropyl methyl cellulose as a feed additive for all animal species. Consequently, the FEEDAP Panelconcludes that the use of HPMC in animal nutrition is of no concern for consumer safety. Guidance on the assessment of the safety of feed additives for the target species. 7Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. PDF Safety Data Sheet - Parchem The applicant claims that the feed additive HPMC is specified to be manufactured to meet the specifications set for its use as a food additive. Guidance on studies concerning the safety of use of the additive for users/workers. The use of hydroxypropyl methyl cellulose in animal nutrition is of no concern for consumer safety. Hydroxypropyl methylcellulose is also used in toothpaste and tooth whitening products because it increases viscosity without adding flavor or color.Hydroxypropyl methylcellulose is often called HPMC for short. 2008. Cellulose is a linear homopolymer consisting of repeating dglucopyranosyl units linked via (1,4) glycosidic bonds. HPMC is more water soluble and is therefore used in more industries than methyl cellulose. After fully dissolved in water, it will form a transparent viscous solution. If you have questions about side effects, call your doctor. Call your doctor for medical HPMC is derived from cellulose, which is a natural polymer. It is commonly used as a food additive and as a thickening agent in many products, including cosmetics, pharmaceuticals, and construction materials. Hydroxypropyl methylcellulose (Fig. Some surfactants and other ingredients make HPMC incompatible with others. The intrinsic digestibility of cellulose depends on the origin and treatment of the forage. MeSH Keep all drugs out of the reach of children and pets. Both methyl cellulose and HPMC are widely used and have a variety of applications. pharmacist if you have questions about the best way to throw out drugs. Read all information given to you. OJ L 268, 18.10.2003, p. 29. What Are The Hydroxypropyl Methylcellulose Side Effects - ECHEMI The following conclusions apply only to hydroxypropyl methyl cellulose meeting the food additive specifications. Data sources include IBM Watson Micromedex (updated 14 May 2023), Cerner Multum (updated 28 May 2023), ASHP (updated 10 Apr 2023) and others. SAFETY DATA SHEET Revision Date 20-Feb-2020 Revision Number 2 1. This includes your doctors, nurses, pharmacists, and dentists. The production process for Hydroxypropyl Methylcellulose involves the esterification of cellulose with propylene oxide followed by hydrolysis and neutralization. The most relevant feeding studies with HPMC (E 464) were performed in rats which tolerated up to 10%, corresponding to 9,000mg test item/kg bw per day. Several studies were conducted in rats with methyl cellulose (E 461) via feed or drinking water or by gavage at concentrations up to 5% (2,500mg methyl cellulose/kg bw per day) and for up to 2years. Hydroxypropyl methyl cellulose (HPMC; CAS No. Before Components CAS-No.IARCACGIH - Carcinogens NTPOSHA HCS - Carcinogens Australia - Notifiable Carcinogenic The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of HPMC as a feed additive. Bethesda, MD 20894, Web Policies However, molar substitution is also often expressed in percentages. It is manufactured by reacting alkali cellulose with propylene oxide at elevated pressure and temperature to yield a highly substituted cellulose ether, with . Its an excellent thickener. Hydroxypropyl methyl cellulose is intended to be used as a technological additive (functional group: emulsifier, stabiliser, thickener, gelling agent and binder) in feedingstuffs for all animal species, with no recommendation of a minimum or maximum content. Methyl cellulose is a water-soluble polymer made from cellulose. Before In the absence of data, the FEEDAP Panelwas not in the position to conclude on the safety of hydroxypropyl methyl cellulose for the user. Acknowledgments: The Panelwishes to acknowledge the contribution of Angelica Amaduzzi to this opinion. There was no indication for carcinogenic effects for all tested compounds. Hydroxypropyl Methylcellulose : Importance, Usage, Pros And Cons Brand names: GenTeal Mild to Moderate, GenTeal Mild, GenTeal Severe, Gonak, Goniosoft, The molecular weight of the HPMC affects the transparency and viscosity of HPMC solutions. See how this product scores for common concerns. You may need to purchase one that is specifically designed for HPMC. It is also used as a binder in tablet manufacturing and as a film-forming agent in cosmetics. In fact, cellulose-based polymers are essential additives for formulations such as tile adhesives, wall fillers, ETICS/EIFS and others. : 44779 CAS-No 9004-65-3 Synonyms No information available Recommended Use Laboratory chemicals. The inflexibility/viscosity of the resulting mass, however, is directly related to the concentration of the methoxy group (the higher the concentration is, the more viscous or less flexible the resulting mass is)[citation needed]. Cellulose and cellulose derivatives were evaluated for their safety by JECFA (1990), which allocated a group ADI of not specified. while you are pregnant. Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. Although the data set available for the different celluloses is not complete and most of the studies were old and do not meet the current requirements of toxicological testing, the ANS Panelconsidered that the physicochemical, structural, biological and kinetic similarities between the modified celluloses make it possible to apply a readacross approach among the different celluloses. Since 1976 I have used a solution of hydroxypropyl methycellulose to prevent corneal endothelial damage during intraocular lens implantation. http://www.pubmed.gov. A generalised structure of HPMC is shown in Figure11. The degree of substitution of the hydroxypropyl groups affects the transparency and the viscosity of HPMC solutions. Therefore, the use of HPMC as a feed additive is considered safe for the environment. MikaZone is the trademark of Meikais cellulose etherand its derivatives. HPMC is also very versatile. The additive is considered to be efficacious in feedingstuffs for all animal species. Theyre non-toxic, biodegradable and non-carcinogenic. HPMC is a white, powdery substance that is soluble in water and other solvents. HPMC is approved by FDA as both a direct and an indirect food additive, and is approved for use as a food additive by the EU. Details of the supplier of the safety data sheet Hydroxypropyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser and thickener) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. . Fluxactive Reviews: Real Customer Reviews, Where To Buy, Pros And Cons! All Rights Reserved. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. There was no indication for carcinogenic effects for all tested compounds. The Scientific Committee for Food (SCF, 1994, 1999) who assessed five closely related cellulose derivatives, also allocated a group ADI of not specified. In poultry, most data in the literature tend to demonstrate that the cellulose complex from plant feedingstuffs that exhibits high crystallinity and water insolubility is not digested (Janssen and Carr, 1985). To get the best bargain, make sure to compare rates from several providers.HPMC is a better alternative to consider when picking an additive for your construction projects. So if youre using a product that contains this ingredient, you shouldnt worry about it affecting your test results. Typically, this critical (congealing) temperature is inversely related to both the solution concentration of HPMC and the concentration of the methoxy group within the HPMC molecule (which in turn depends on both the degree of substitution of the methoxy group and the molar substitution). A digestibility study carried out in the trout and the carp administered a purified (devoid of lignin and reduced amount of hemicelluloses) crystalline cellulose extracted from wood (fibre length 150m, diameter 45m), showed the practical absence of cellulose degradation in both species (Bergot and Breque, 1983). Hydroxyethylcellulose, Hydroxypropylcellulose, Methylcellulose, Hydroxypropyl Methylcellulose, and Cellulose Gum are modified cellulose polymers that are used in cosmetic products at concentrations up to 10%. It is normally found in levels that are less than five percent of the total constitution of the product and is considered safe by many health regulatory groups. EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of HPMC in animal feed. It is also not comedogenic, so it does not cause acne breakouts. This means that CMC can be used in a wider range of products. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary. It has a wide range of uses, including as a thickener (as a substitute for cornstarch), a stabilizer (to prevent ingredients from separating or settling), a binding agent (to hold ingredients together), or an emulsifier (to blend two substances that dont dissolve well in each other). : 9004-65-3 HS Code: 3912900000 Send An Email Now Get A Quote Online Hydroxypropyl Methylcellulose (HPMC) is an odorless, non-toxic white powder. As far as cellulose is associated to lignin, hemicelluloses and cutin in natural forages, a wide range of digestibility is observed (30 to 90%). EFSA ANS Panel The following conclusions apply only to HPMC meeting the food additive specifications. If youre wondering whether hydroxypropyl methylcellulose will show up on a drug test, the answer is probably not. Since there are maximum three possible sites of substitution with each cellulose molecule, this average value is a real number between 0 and 3. No specific data on the efficacy of HPMC in feedingstuffs were provided. Hydroxypropylcellulose (HPC) is a cellulose ether in which hydroxyl groups on the cellulose backbone have been hydroxypropylated. Digestibility of cellulose was shown to amount to 16% of the administered dose, whereas values of 14% and 18% were reported for fibre (cellulose being the main component) (review from the NRC, 1977). Methyl cellulose is a water-soluble polymer made from cellulose. A proper identification and characterisation of hydroxypropyl methyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. HPMC is made by treating cellulose with propylene oxide and methyl chloride. The https:// ensures that you are connecting to the Federal government websites often end in .gov or .mil. In this post, well take a closer look at this fascinating substance and learn more about its many uses. doi: 10.1006/rtph.1999.1335. The applicant did not provide new studies on the safety of HPMC, but made reference to previous assessment of celluloses (as a group) performed by other scientific bodies. Conducting a patch test is recommended. Modified celluloses. Histological examination revealed no intestinal abnormality or evidence of the passage of the additive across the intestinal wall in either species and the tumour incidences were comparable among groups. Cellulose is considered suitable and is processed by using naturally occurring fibers through alkali fusion, grafting response, washing, drying, grinding and other processes. EFSA FEEDAP Panel The Applicant states that the specific purity criteria set in Commission Regulation (EU) 231/2012 for the use of methyl cellulose and hydroxyropyl methyl cellulose as food additives are also applicable when using them as feed additives. There is only a modest volume of research. EWG Skin Deep | What is HYDROXYPROPYL METHYLCELLULOSE Some of the most common uses for HPMC are: How is Hydroxypropyl Methylcellulose produced? Setting a maximum content in complete diets is not considered necessary. Development of Inhalable Spray Dried Nitrofurantoin Formulations for the Treatment of Emphysema. In ruminants, cellulose is first hydrolysed by ruminal microorganisms into cellobiose, then is fermented to pyruvate and finally volatile fatty acids. The study on rabbits was discarded due to poor experimental design. Additionally, if youre undergoing a hair follicle test, hydroxypropyl methylcellulose could potentially be detected.In most cases, however, hydroxypropyl methylcellulose will not show up on a drug test. Scientific Opinion on the safety and efficacy of hydroxypropyl methyl cellulose for all animal species. When applied, a hypromellose solution acts to swell and absorb water, thereby expanding the thickness of the tear-film. 1 Executive Summary 2 3 Hydroxypropyl methylcellulose (HPMC) was petitioned as an ingredient of hard capsules used for encapsulating 4 powdered herbs. The Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1990) assessed the compound together with six other cellulose derivatives and allocated a group acceptable daily intake (ADI) of not specified. Be ready to tell or show what was In summary, cellulose is a natural part of feed and plays a physiological role in nutrition of animals (see Section3.2.1). The concentration of the HPMC solution affects the viscosity of the solution. The global hydroxypropyl methylcellulose market is expected to grow from $4.14 billion in 2022 to $4.40 billion in 2023 at a compound annual growth rate (CAGR) of 6.3%.The Russia-Ukraine war . Unable to load your collection due to an error, Unable to load your delegates due to an error. 8600 Rockville Pike HPMC has several side effects. In the absence of data, the FEEDAP Panelis not in the position to conclude on the safety of ethyl cellulose for the user. I. Throw away unused or expired drugs. the contents by NLM or the National Institutes of Health. SCF National Library of Medicine No maternal or fetal toxicity was detected in Golden hamsters exposed via gavage (vehicle corn oil) up to 1,000mg methyl cellulose (E 461) mg/kg bw per day from day 6 to 10 of gestation followed by a caesarean section at day 20. Rabbits tolerated up to 7,500mg HPMC/kg bw per day administered via the diet (30day exposure) and dogs up to 1,500mg HPMC/kg bw per day, in either case being the highest tested dosages. It helps keep food fresh longer by creating a protective coating on the surface of the product. However, the absence of significant metabolism in the rat and the human indicates that, despite an increase of water solubility, the etherification of cellulose would strongly limit the action of microbial cellulases. Five batches of the additive were analysed for some of the above specifications, resulting in: methoxyl groups (four batches) 23.529.2%, hydroxypropoxyl groups (four batches) 5.28.4%, loss on drying (one batch) 1.2% and sulfated ash (one batch) 0.6%. Among those meeting the current criteria for toxicological testing, the no observed adverse effect level (NOAEL) values for the different modified celluloses were identified most often corresponding to the highest tested level or changes in body or organ weights. The FEEDAP Panelused the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peerreviewed scientific papers, to deliver the present output. Cellulose is a crucial structural component of plants and is found in the cell walls of all plants. Various benchmark tests are used to qualify hypromellose: Because hypromellose solution is a non-newtonian solution and exhibits pseudoplastic, more specifically, thixotropic behavior, various test methods are available, and the results of different methods and viscosimeters do not necessarily correspond to each other. Int J Toxicol. SCF While HPMC is a very effective adhesive, it can be hard to find at a reasonable cost in some places. 2Association Management & Regulatory Services Ltd, Kerkweide 27, 2265 DM Leidschendam, Netherlands. It can be used in many different contexts, such as building, adhesives, coatings, and sealants. Post-application, celluloid attributes of good water solubility reportedly aid in visual clarity. Hydroxypropyl Methylcellulose is a water-soluble fiber that can be turned into a thick gel when mixed with water. It can be used to thicken liquids, so its often used in shampoo, conditioner, and other hair care products. 10.2903/j.efsa.2020.6214 Would you like email updates of new search results? Eisele J, Haynes G, Kreuzer K, Rosamilia T. Regul Toxicol Pharmacol. Bethesda, MD 20894, Web Policies In the formulation of dry mortar in the building materials industry, the use of cellulose-based polymers is common. The DS of HPMC is usually between 0.7 and 1.4. Hydroxypropyl methylcellulose (HPMC) is a non-fermentable semi-synthetic dietary fibre, based on cellulose (Burdock, 2007), which is a carbohydrate consisting of anhydroglucose units (Reppas, Swidan, Tobey, Turowski, & Dressman, 2009). In the horse, digestion of plant structural carbohydrates (including cellulose) occurs in the hindgut (colon and overall caecum). Do this for 1 to 2 minutes. But gastrointestinal microbes can split cellulose, the main degradation products are shortchain fatty acids. A generalised structure of hydroxypropyl methyl cellulose. Their reproductive ability was seemingly not affected and no abnormalities were found in the F1derived fetuses. Hypromellose solutions were patented as a semisynthetic substitute for tear-film. Hydroxypropyl methylcellulose (HPMC) is a good option if you require an additive to raise the caliber of your construction projects. No specific information was submitted. Both HPMC and MC are cellulose-based polymers derived from plant cellulose. The in utero exposure to the highest dose (5,000mg/kg bw per day) may be considered as the NOAEL of methyl cellulose (E 461) for this study. The main difference between the two is that HPMC has been modified with hydroxpropyl groups. Hydroxypropyl Methylcellulose Information - Drugs.com WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. If hydroxypropyl methylcellulose is put in the mouth or swallowed, call a doctor or poison control center right away. The additive consists of pure HPMC and is free from any other added components. This makes it ideal for use in foods such as yogurt and ice cream, as it prevents them from separating or clumping together. Hydroxypropyl Methylcellulose: Cosmetic Ingredient INCI - SpecialChem The HPMC is very stable. Hydroxypropyl methyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. Its also used as a thickening or binding agent.While hydroxypropyl methylcellulose is not likely to show up on a drug test, there are a few potential exceptions. Be sure you know if this product needs to be shaken before using it. Be sure you know if you need to avoid wearing contact lenses