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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). Some studies were unfit for evaluation due to methodological shortcomings. In the only relevant study, the dietary administration of even high doses of microcrystalline cellulose (E 460) (30%, 15,000 mg/kg bw) to rats for 72 weeks did not affect survival, feed efficiency or haematology. Apart from some dystrophic calcification in renal tubules, no other relevant lesions were noted and tumour incidence did not differ with that of controls. Several studies were conducted in rats with methyl cellulose (E 461) via feed or drinking water or by gavage at concentrations up to 5% (2,500 mg methyl cellulose/kg bw per day) and for up to 2 years. 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. In the only identified study, the daily dosing of male and female rats (0, 1,500, 3,000 or 6,000 mg hydroxypropyl cellulose/kg bw) via gavage for 6 months did not cause adverse effects (including carcinogenicity) apart from a decrease in body weight in high-dosed rats (statistically significant in females only). Apart from a decrease in body weights of high-dosed males, no other significant adverse findings were reported and there was no indication of a carcinogenic effect in rats of either sex dietary exposed to HPMC (E 464) up to 20% (10,000 mg/kg bw per day) for 1 year. Carboxy methylcellulose (E 466) was tested in mice and rats at dosages of 0, 10,000 or 100,000 mg/kg diet (equivalent to 0, 1,500 or 15,000 mg/kg bw per day for mice and to 0, 500 or 5,000 mg/kg bw per day for rats) for up to 104 weeks. Despite the increase in feed intake, a treatment related decrease in body weight was noted at the end of the treatment. 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.

3.3 Efficacy

Major Producers:

The largest HPMC manufacturers are global chemical and pharmaceutical companies that have manufacturing capabilities in several countries. Among these, we can mention Dow Chemical Company, Ashland, and Shin-Etsu Chemical. These companies are known for their ability to produce high-quality HPMC suitable for a wide range of applications, including those requiring high standards such as the pharmaceutical and food industries.

Importance in the Gluten Free Food Industry:

In the context of gluten-free, the importance of HPMC has grown alongside the growing awareness and diagnosis of celiac disease and other gluten sensitivities. The need for gluten-free products that maintain the sensorial and structural qualities of traditional foods has driven the search for effective additives such as HPMC.

Current Considerations:

Although HPMC is widely used and generally considered safe, the current trend in the food industry is moving towards less processed and more natural ingredients. This may influence consumer perceptions of HPMC and other similar additives. However, its effectiveness as a gluten substitute in gluten-free preparations still makes it a valuable ingredient for many producers and consumers.

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This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.