Biomaterial Database

Safety assessment of hydroxypropyl methylcellulose as a food ingredient. 2007

George A Burdock

Burdock Group, 2001 9th Ave Suite 301, Vero Beach, FL 32960, USA. gburdock@burdockgroup.com

Hydroxypropyl methyl cellulose (HPMC; CAS No. 9004-65-3) is an odorless and tasteless, white to slightly off-white, fibrous or granular, free-flowing powder that is a synthetic modification of the natural polymer, cellulose. It is used in the food industry as a multipurpose food ingredient. 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. The JECFA has evaluated the food uses of HPMC and established an acceptable daily intake (ADI) of 'not specified' for such uses. Based on the no-observed-adverse-effect level (NOAEL) of 5000 mg/kg body weight/day from a 90-day feeding study in rats, a tolerable intake for ingestion of HPMC by humans of 5 mg/kg body weight/day is posited and, as such, is more than 100-fold greater than the estimated current consumption of 0.047 mg/kg body weight/day.

UI	MeSH Term	Description	Entries
D008747	Methylcellulose	Methylester of cellulose. Methylcellulose is used as an emulsifying and suspending agent in cosmetics, pharmaceutics and the chemical industry. It is used therapeutically as a bulk laxative.	BFL,Celevac,Cellothyl,Cellulone,Citrucel,Cologel,Dacryolarmes,Methocel,Methyl Cellulose,Muciplasma,Cellulose, Methyl
D003257	Consumer Product Safety	The sum total of measures taken and regulatory policies enacted to ensure the safe use of consumer products.	Safety, Consumer Product,Product Approval,Product Approvals,Product Safety, Consumer
D005503	Food Additives	Substances used in the processing or storage of foods or animal feed including ANTIOXIDANTS; FOOD PRESERVATIVES; FOOD COLORING AGENTS; FLAVORING AGENTS; ANTI-INFECTIVE AGENTS; EXCIPIENTS and other similarly used substances. Many of the same substances are used as PHARMACEUTIC AIDS.	Additive, Food,Additives, Food,Food Additive
D005524	Food Technology	The application of knowledge to the food industry.	Technology, Food,Food Sciences,Food Science,Science, Food,Sciences, Food
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D051381	Rats	The common name for the genus Rattus.	Rattus,Rats, Laboratory,Rats, Norway,Rattus norvegicus,Laboratory Rat,Laboratory Rats,Norway Rat,Norway Rats,Rat,Rat, Laboratory,Rat, Norway,norvegicus, Rattus
D019055	No-Observed-Adverse-Effect Level	The highest dosage administered that does not produce toxic effects.	NOAEL,No-Observed-Effect Level,Acceptable Daily Intake,Tolerable Daily Intake,Acceptable Daily Intakes,Daily Intake, Acceptable,Daily Intake, Tolerable,Daily Intakes, Acceptable,Daily Intakes, Tolerable,Intake, Acceptable Daily,Intake, Tolerable Daily,Intakes, Acceptable Daily,Intakes, Tolerable Daily,Level, No-Observed-Adverse-Effect,Level, No-Observed-Effect,Levels, No-Observed-Adverse-Effect,Levels, No-Observed-Effect,No Observed Adverse Effect Level,No Observed Effect Level,No-Observed-Adverse-Effect Levels,No-Observed-Effect Levels,Tolerable Daily Intakes
D065347	Hypromellose Derivatives	Polymeric compounds that contain repeating units of hydroxypropyl methylcellulose. The properties of hypromellose polymers can vary greatly and are defined by their molecular weight, the percentage of hydroxyl groups, the percentage of hydroxypropyl groups, and viscosity measurements. They are found a broad variety of commercial products such as FOOD ADDITIVES; EXCIPIENTS; and LUBRICANTS.	HPMC 2910,HPMC-K-100 M,Hydroxypropyl Methylcellulose,Hydroxypropylmethylcellulose,Hypromellose,K-8515,K8515,MHPC Polymer,Methocel E,Methoxyhydroxypropylcellulose,Methyl Hydroxypropyl Cellulose,Methyl-hydroxypropyl-cellulose,Derivative, Hypromellose,Derivatives, Hypromellose,HPMC K 100 M,HPMCK100 M,Hypromellose Derivative,K 8515