CELLULOSE
Molecular Formula. C6H7O2(OH)3
CAS No 9004-34-6, 9006-02-4, 39394-43-9, 58968-67-5, 61991-21-7, 61991-22-8,
84503-75-3, 99331-82-5
RTECS No FJ5691460
Abbreviation. MCC (microcrystalline cellulose).
Composition. Cellulose is a natural polymer, the main component of the cell walls of the more highly developed plants. It is found in greatest quantity in wood, and in the fibers of cotton, flax, etc.
Application. Used as a filler in the production of some plastics, in fiber form as packing material, and in pharmaceutical practice. C. ethers and esters are widely used synthetic polymers.
Migration Data. Chocolates, boiled sweets, toffees, cakes, and meat pies were wrapped in regenerated C. films that contained various mixtures of glycol softeners. It was shown that higher levels of migration occurred for propylene glycol than for triethylene glycol, and the presence of coating reduced the migration of both softeners. Mono- and diethylene glycol levels in the food samples were below 10 mg/kg. 1
Short-term Toxicity. Sprague-Dawley rats received 500, 2500, or 5000 mg MCC/kg BW (25% w/v in tap water) by oral gavage for 90 days. MCC particles were not observed in any tissue examined. No ill effects were found in any other parameter or organ evaluated. The NOAEL was found to be more than 5000 mg/kg BW, which was the highest dosage tested.
Long-term Toxicity. Chronic ingestion of purified C. over the entire life-spans in rats and mice does not result in any increase in spontaneous disease. Purified C. does not display promotional activity in the mammary gland, the colon, or the bladder of rats and does not significantly alter the absorption or the metabolism of dietary components.
Reproductive Toxicity including deviations in neonate development was not observed in animals exposed orally to purified C.3
Carcinogenicity. Ingestion of cellulose was not carcinogenic in lifetime feeding studies in rats and mice .3
Chemobiokinetics. Ingestion of purified C. does not significantly alter the absorption or metabolism of the main dietary components. 3
Regulations.
EU (1990). C. is available in the List of authorized monomers and other starting substances, which shall be used for the manufacture of plastic materials and articles intended to come into contact with foodstuffs (Section A).
Great Britain (1998). C. is authorized without time limit for use in the production of polymeric materials and articles in contact with food or drink or intended for such contact.
Recommendations. EU (1995). C. is a food additive generally permitted for use in foodstuffs. References:
1. Castle, L., Cloke, H. R., Crews, C., and Gilbert, J., The migration of propylene glycol, mono-, di-, and triethylene glycols from regenerated cellulose film into food, Z. Lebensmitt. Untersuch. Forsch., 187, 463, 1988.
2. Kotkoskie, L. A., Butt, M. T., Selinger, E., Freeman, C., and Weiner, M. L., Qualitative investigation of uptake of fine particle size microcrystalline cellulose following oral administration in rats, J. Anat., 189, 531, 1996.
3. Anderson, R. L., Owens, J. M., and Timms, C. W., The toxicity of purified cellulose in studies with laboratory animals, Cancer Lett., 63, 83, 1992.
CELLULOSE ACETATES
CAS No 9004-35-7, 9035-69-2 (cellulose diacetate),
9012-09-3 (cellulose triacetate)
Abbreviation. CA.
Composition. CA are partially acetylated cellulose: ester of cellulose and acetic acid (R = CH3). Several CA differ from one another only in the degree of acetylation.
Synonym and Trade Names. Acetate cotton; Acetose; Bioden; Cellidor; Cellulose 2,5-acetate.
Properties. White or colorless flakes or powder. Triacetate and tetracetate cellulose are insoluble in water and alcohol. It is easily deformed by heat, acids, bases, and some solvents, but it is resistant to fats and oils. Maximum continuous service temperature for CA is 80°C.
Applications. Used in the manufacture of rubber and celluloid substitutes, and in the production of films (together with acetic acid, acetone, and caprolactam). Intended for use in aqueous and alcoholic media with pH 3.0 to 8.0 up to 50°C. CA is used to produce transparent, water resistant, non-combustible film for packing medicines and foodstuffs. CA membranes are used in the dairy industry for utilizing whey and producing high-purity milk proteins for children, in the pharmaceutical industry, for desalination of salty waters, and for concentrating juices.
Migration of CA constituents into contact fluids
was found to be negligible (traces). At 40°C, triethanolamine was discovered in
the extract at a concentration of 1.4 mg/l and was therefore subsequently
eliminated from CA formulation.1
Aqueous extracts of film plasticized with triacetin (glycerol
triacetate) and triethylene glycol dipropionate are transparent, colorless, and
have no sediment. The extracts exhibit a foreign odor and sourish taste,
irrespective of temperature or exposure. Triacetin migrates at the level of 1.1
to 1.6 mg/l and triacetin degradation product (acetic acid) migrate at the level
of 0.5 to 2.0 mg/l. Triethylene glycol propionate was found in the aqueous
extracts at the level of 0.8 to 2.5 mg/1.2
No increase in oxidizability level was found in distilled
water or in 2.0% citric acid solution after a 10-day contact with MGA type of CA
membranes. At 20 and 60°C, the extracts had no foreign odor. Only
"MGA-640" CA membrane induced a small change in the taste of extracts.
There was no migration of acetone and caprolactam from the membranes.
Migration into quiches of diethyl phthalate at the level of
2.0 to 4.0 mg/kg from CA film purchased from retails and take-away outlets was
determined.
Short-term Toxicity. Sprague-Dawley rats were exposed to a dietary admixture of CA at dose levels of 0.5, 2.5, and 5.0 g/kg BW for 3 months. There were no treatment-related changes in hematology, clinical chemistry and urinalysis. Gross pathology and histopathology examination revealed no evidence of an adverse effect related to ingestion of CA.5
Long-term Toxicity. Rats received aqueous extracts from MGA CA membrane instead of the drinking water over a period of 8 months. The exposure caused no toxic effect.'
Reproductive Toxicity.
Embryotoxicity. There were no effects on
reproduction in rats given aqueous extracts of CA membranes as their drinking
water.' Sound embryotoxic action was observed in rats that consumed aqueous
extracts of CA films treated with formamide, over the entire gestation period (Shtannikov
et al., 1972).
Regulations. U.S. FDA (1998) approved use of CA as the basic polymer in the manufacture of resinous and polymeric coatings for the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. Affirmed to be GRAS as a substance migrating to food from paper and paperboard products.
References:
1. Selivanov, S. B., Hygiene Investigation and Assessment of Reverse Osmosis Method for Desolination of Drinking Water in "Filter-Press "-Type Installations, Author's abstract of thesis, 2nd Moscow Medical Institute, Moscow, 1977, 18 (in Russian).
2. Kas'an, V. N., in Proc. IV All-Union Sci.-Techn. Conf. Synthesis and Applications of Polymeric Materi als Used in Food Industry, Minsk, 1980, 128 (in Russian).
3. Kodner, M. S. and Mamayeva, Z. A., in Proc. of IV All-Union Conf Membrane Methods for Mixture Separation, April 12-14, 1977, Vladimir, 1977, 414 (in Russian).
4. Castle, L., Mercer, A. J., Startin, J. R., and Gilbert, J., Migration from plasticized films into foods. 3. Migration of phthalate, sebacate, citrate and phosphate esters from films used for retail food packaging, Food Addit. Contam., 5, 9, 1988.
5. Thomas, W. C., McGrath, L. F., Baarson, K. A., Auletta, C. S., Daly, I. W., and McConnell, R. F., Subchronic oral toxicity of cellulose acetate in rats, Food Chem. Toxicol., 29, 453, 1991.
CELLULOSE ACETATE BUTYRATE
CAS No 9004-36-8
Abbreviation. CAB. Synonym. Cabufocon.
Properties. White powder with a characteristic butyric acid odor. M. p. 127 to 240°C. Solubility in water is negligible.
Applications. Used in the manufacture of coatings. Cabufocon is a contact lens material. Toxicity. Expected to exhibit a low ingestion hazard.
Regulations. US FDA (1998) approved use of CAB (1) in adhesives as a component of articles intended for use in packaging, transporting, or holding food, subject to the conditions prescribed in 21 CFR part 175.105; (2) in production of hot-melt strippable food coatings which may be applied to food, subject to the conditions prescribed in 21 CFR part 175.230; (3) as the basic polymer in the manufacture of resinous and polymeric coatings for the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the conditions prescribed in 21 CFR part 175.300; and (4) in the manufacture of cellophane for packaging food in accordance with the conditions prescribed in 21 CFR part 177.1200.
CELLULOSE ACETATE PROPIONATE
CAS No 9004-39-1
Abbreviation. CAP.
Composition. A mixed ester of cellulose and acetic and propionic acids (R = CH3 and C2H5). The technical grade product consists of 1.5 to 7.0% acetyl groups and 39 to 45% propionyl groups.
Applications. Used in the production of films.
Migration Data. Aqueous extracts of films plasticized with triacetin (glycerol triacetate) and triethylene glycol dipropionate are transparent, colorless, and have no sediment. The cold and hot extracts exhibited a foreign odor and a sourish taste. Triacetin plasticized films released the plasticizer at the level of 1.1 to 1.6 mg/l. 1
Reproductive Toxicity. Mice were treated i/p with doses of 100 mg CAP/kg BW on days 3 through 7 of pregnancy. The treatment caused an increase in post-implantation mortality.2
Regulations. U.S. FDA (1998) approved use of CAP in production of hot-melt strippable food coatings which may be applied to food, subject to the conditions prescribed in 21 CFR part 175.230.
References:
1. Kas'an, V. N., in Proc. IV All-Union Sci.-Techn. Conf Synthesis and Applications of Polymeric Materials Used in Food Industry, Minsk, 1980, 128 (in Russian).
2. Guttnerm, J., Klaus, S., and Heinecke, H., Embryotoxicity of intraperitoneally administered hydroxyethylcellulose in mice, Anat Anzeiger, 149, 282, 1981.
HYDROXYETHYL CELLULOSE
Molecular Formula. {~C6H7O2 (OH)3-X[(OCH2CH2),OH]x~}n
CAS No 9004-62-0
Abbreviation- HEC.
Synonyms and Trade Names. Cellosize QP; Hydroxyethyl cellulose ether; Natrosol. Composition. Cellulose ester, the product of its interaction with ethylene oxide.
Properties. White free flowing powder, without taste and odor. Readily soluble in hot and cold water; insoluble in organic solvents, fat, and oils.
Applications. A thickener in latex paints; protective colloid, binder stabilizer, paper sizing agent.
Acute Toxicity. Administration of a single oral dose of up to 23 g HEC/kg BW (50% solution in com oil) caused no toxic effect °3 Ingestion of large quantities induced intestinal obstruction- Toxic action was noted at the doses in excess of 2.0 g/kg (Dreisbach, 1977).
Long-term Toxicity. Rats received 0.2, 1.0, or 5.0% HEC in their diet over a period of 2 years. The treatment produced no adverse effects on growth, food intake, life-span, frequency of extraneous infections, body measurements, kidney and liver weights, hematology analyses, occurrence of neoplasms. Histological examination revealed no changes in the visceral organs.03
Allergenic Effect. Skin sensitization seems to be unusual (Dreisbach, 1977).
Chemobiokinetics.
Observations in man. Following ingestion, cellulose ethers are not
absorbed but eliminated unchanged with feces. 03
Regulations. US FDA (1998) approved use of HEC (1) as a constituent of food-contact adhesives which may safely be used as a component of articles intended for use in packaging, transporting, or holding food in accordance with the conditions prescribed in 21 CFR part 175.105; (2) in the manufacture of resinous and polymeric coatings for the food-contact surface of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the conditions prescribed in 21 CFR part 175.300; and (3) in the manufacture of cellophane for packaging food in accordance with the conditions prescribed in 21 CFR part 177-1200. Water insoluble HEC film may be safely used (4) in packaging food in accordance with the conditions prescribed in 21 CFR part 177.1400-
Standards. Russia (1995). RAL: 1.0 mg/l.
source: Sheftel, VO. Indirect Food Additives and Polymers. Lewis Boca Raton (2000)
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