ГОСТ ISO 10993-7— 2011
[86] Pharmaceutical Manufacturers’ Association. Application of the PMA procedure for setting residue limits for organic
volatile solvents in pharmaceuticals to ethylene oxide. Prepared by D.L. Conine and the PMA subcommittee of
Industrial Toxicologists. Procedures for setting limits for organic volatile solvents with chloroform. 1,4-dioxane,
ethylene oxide, and trichloroethylene as examples of the process. Committee on Rational Specifications for
Impurities in Bulk Drug Substances — Parmaceutical Manufacturers’ Association. In: Pharmacopeial Forum.
Washington. DC: PMA. May-June 1990; pp. 557—572
[87] RAGELIS. E.P.. FISHER. B.S.. KIMECK. B.A. and JOHNSON. C. Isolation and determination of chlorohydrins in
foods fumigated with ethylene oxide or propylene oxide. J. Assoc. Off. Anal. Chem. 51(3) 1968. pp. 709— 717
[88] ROMANO. S.J. and RENNER. J.A. Comparison of analytical methods for residual ethylene oxide analysis.
J. Pharm. Sci. 64(8) 1975: pp. 1412— 1417
[89] ROMANO. S.J.. RENNER. J.A. and LEITNER. P.M. Gas chromatography determination of residual ethylene oxide
by head space analysis. Anal. Chem. 45(14) 1973; pp. 2327—2330
[90] ROWE. V. and McCOLLISTER. S. Alcohols Chapter Fifty-Five. In: Clayton. G.; Clayton. F. (Eds.). Patty’s Industnal
Hygiene and Toxicology (0-ded. VoJ. 2C Toxicology). New York. NY: John Wiley & Sons. Inc. 1982: pp. 4675—4684
[91] ROWE. V. and WOLF. M. Glycols. Chapter Fifty. In: Clayton. G.: Clayton, F. (Eds.). Patty’s Industrial Hygiene and
Toxicology (3rd ed. Vol. 2C Toxicology). New York. NY: John Wiley & Sons. Inc. 1982: pp. 3817—3832
[92] RTECS. Registry of Toxic Effects of Chemical Substances 1985— 1986. National Institute for Occupational Safety
and Health. DHHS (NIOSH) Publication No. 87-1 14. Rockville. MD. 1987; pp. 2361—2362
[93] RTECS. Registry of Toxic Effects of Chemical Substances. National Institute for Occupational Safety and Health.
On line. Rockville. MD. 1990
[94] SCUDAMORE. K.A. and HEUSER. S.G. Ethylene oxide and its persistent reaction products in wheat flour and other
commodities, residues from fumigation or sterilization, and effects of processing. Pesticide Science. 2 1971; pp.
80—81
[95] SHIMIZU. H., OHARA. K. and SAWA. M. Sterile anterior segment inflammation presumably due to absorbed
ethylene oxide to the implanted intraocular lens. Rinsho Ganka (Japanese J. Сйп. Ophthalmol.) 40(1 I) 1986; pp.
1219— 1225
[96] SNELLINGS. W.. MARONPOT. R.. ZELENAK. J. and LAFFOON. C. Teratology study in Fischer 344 rats exposed to
ethylene oxide by inhalation. Tox. Appl. Pharm. 64 1982a; pp. 476— 181
[97] SNELLINGS. W.. ZELENAK. J. and WEIL. C. Effects on reproduction in Fischer rats exposed to ethylene oxide by
inhalation for one generation. Tox. Appl. Pharm. 63 1982b: pp. 382—388
[98] SNELLINGS. W.. WEIL. C. and MARONPOT. R. A subchronic inhalation study on the toxicologic potential of ethylene
oxide in B6C3FI mice. TOX. Appl. Pharm. 76 1984a; pp. 510—518
[99] SNELLINGS. W.. WEIL. C. and MARONPOT. R. A two-year inhalation study of the carcinogenic potential of ethylene
oxide in Fischer 344 rats. Tox. Appl. Pharm. 75 1984b; pp. 105— 117
[100] SNYDER. L.R. A rapid approach to selecting the best experimental conditions for high-speed liquid column
chromatography — Part 1 — Estimating initial sample resolution and the final resolution required by a given
problem. J. Chromatogr. So. 10 1972: pp. 201—212
[101] SPITZ. H.D. and WEINBERGER. J. Determination of ethylene oxide, ethylene chlorohydrin and ethylene glycol by
gas chromatography. J. Pharm. Sd. 60(2) 1971: pp. 271—274
[102] TANAKA. S., NAKAURA. S.. KAWASHIMA. K.. KASUYA. Y.andOMORI. Y. Studieson the hemolytic activity and dermal
irritability of ethylene oxide and its reaction products. Jap. J. Med. Instrum. 52(l) 1982; pp. 21—28
[103] TYL. R. Developmental ToxicityEvaluation of Ethylene Glycol Administrated by Gavage to DC(R)-1 Mice: Determination
of a «No-Observable-Effect Level» (NOEL). Report 51-591. Bushy Run Research Center. Union Carbide Corpora
tion. Export. PA. (Study sponsored by Ethylene Glycol Panel.) Washington. DC: Chemical Manufacturers’ Association.
1988
[104] U.S. Environmental Protection Agency. Health Assessment Document for Ethylene Oxide (EPA 600/8-84-009F).
Research Triangle Park. NC: EPA. 1985
[105] U.S. Food and Drug Administration. EO. ECH & EG. Proposed maximum residue limits and maximum levels of
exposure (HEW/FDA). Federa’Register. Washington, DC. 43(122) 1978
[106] U.S. Pharmacopeia. Chromatography (Section 621). United States Pharmacopeial Convention In: United States
Pharmacopeia (22nd ed). Easton. PA: Mack Publishing Co.. 1989
[107] WARREN. B. The determination of residual ethylene oxide and halogenated hydrocarbon propellants in sterilized
plastics. J. Pharm. Pharmacol. 23(suppl.) 1971: pp. 170S—175S
[108] WEIL. C. Statistics vs. safety factors and scientific judgement in the evaluation of safety for man. Tox. Appl. Pharm.
21 1972: pp. 454—463
[109] WOODARD. G. and WOODARD. M. Toxicity of residuals from ethylene oxide gas stenlization. Proceedings of the
Health Industry Association Technical Symposium. Washington. DC.; 1971: pp. 140—161
[110] WEINBERGER. J. GLC Determination of ethylene chlorohydrin following co-sweep extraction. 4. Pharm. Sci. 60(4)
1971; pp. 545—547
[111] WESLEY. F.. ROURKE. B. and DARBISHIRE. 0. The formation of persistent toxic chlorohydrins in foodstuffs by
fumigating with ethylene oxide and propylene oxide. J. Food. Sci. 30 1965: pp. 1037— 1042
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