Powiadomienia systemowe
- Sesja wygasła!
- Sesja wygasła!
Identyfikatory
Warianty tytułu
Hydrazine : documentation of proposed values of occupational exposure limits (OELs)
Języki publikacji
Abstrakty
Hydrazyna jest cieczą, stosowaną w różnych gałęziach przemysłu. Jak oszacowano, w Polsce, w 2011 r., w warunkach narażenia na hydrazynę i jej sole zatrudnionych było około 2000 osób. Związek ten wykazuje silne działanie drażniące oczy, skórę i drogi oddechowe. Hydrazyna została zaklasyfikowana do kategorii 1.B jako substancja rakotwórcza. Jej działanie rakotwórcze udowodniono na podstawie wyników badań na zwierzętach. Skutkiem narażenia były łagodne i złośliwe nowotwory: jamy nosa, płuc i wątroby. Brak jest jednoznacznych dowodów działania rakotwórczego dla ludzi. W Polsce obowiązuje dla hydrazyny wartość NDS 0,05 mg/m3 i wartość NDSCh 0,1 mg/m3. W ACGIH zaproponowano wartość TLV 0,013 mg/m3. W SCOEL nie ustalono wartości normatywnych, ponieważ uznano, że właściwym skutkiem oceny toksycznego działania hydrazyny jest działanie rakotwórcze i genotoksyczne, a ocena możliwego działania dla ludzi nie jest możliwa ze względu na istnienie różnic międzygatunkowych w działaniu rakotwórczym związku na górne drogi oddechowe. W Unii Europejskiej proponuje się wartość wiążącą BOELV 0,013 mg/m3. Na podstawie wyników badań eksperymentalnych na zwierzętach wykazano, że narządem krytycznym w wyniku narażenia na hydrazynę jest wątroba. Do ustalenia wartości NDS wykorzystano wyniki badań – przewlekłego narażenia inhalacyjnego chomików syryjskich na hydrazynę. Skutkiem krytycznym było działanie hepatotoksyczne: skrobiawica, hemosyderoza i rozrost przewodów żółciowych. Wartość LOAEL przyjęto na poziomie 0,332 mg/m3. Wyliczono wartość NDS 0,014 mg/m3 oraz, ze względu na działanie drażniące związku, ustalono wartość NDSCh 0,042 mg/m3, wraz z oznakowaniem: Carc. 1.B (substancja rakotwórcza kategorii 1.B), „Skóra” oraz „I” (substancja drażniąca). Po dyskusji i głosowaniu na 77. posiedzeniu Międzyresortowej Komisji ds. NDS i NDN w dniu 14.01.2015 r. przyjęto stężenie 0,013 mg/m3 za wartość NDS hydrazyny – wartość wiążącą, przyjętą przez ACSH – a wartość 0,039 mg/m3 za wartość NDSCh.
Hydrazine is a liquid used in various industries. In 2011 in Poland, approximately 2000 people were exposed to hydrazine and its salts. This compound is strongly irritating to the eyes, skin and respiratory system. Hydrazine has been classified to a carcinogen category 1.B. Carcinogenicity of hydrazine has been proven in animals. The results of exposure were benign and malignant tumors of the nasal cavity, lungs and liver. There is no conclusive evidence of carcinogenicity in humans. In Poland, TWA of 0.05 mg/m3 and STEL of 0.1 mg/m3 are valid. The ACGIH TLV proposed value of 0.013 mg/m3. The SCOEL did not establish normative values because proper effects to assess toxicity of hydrazine are carcinogenic and genotoxic effects. The assessment of possible effects in humans is not possible because of interspecific differences in the carcinogenic effects on the upper airways. The European Union propose a binding BOELV value of 0.013 mg/m3. Animal studies suggest that a liver is a critical organ as a result of exposure to hydrazine. The results of studies of chronic inhalation exposure of Syrian hamsters to hydrazine were used to determine the value of MAC-NDS. The critical effects were hepatotoxic: amyloidosis, hemosiderosis and proliferation of bile ducts. The LOAEL value is 0.332 mg/m3. Derived limit value is 0.014 mg/m3 and the STEL value is 0.042 mg/m3 because of the irritant effects. Labeling as Carc. 1.B (carcinogenic category 1.B), „Skin” and „I”(irritant) was suggested. After discussion and voting at the 77th meeting of the Interdepartmental Commission for MAC and MAI (January 14, 2015) exposure limit value TWA of 0.013 mg/m3 and STEL value of 0.039 mg/m3 was accepted. This values are consistent with binding values adopted by the ACSH.
Czasopismo
Rocznik
Tom
Strony
35--65
Opis fizyczny
Bibliogr. 87 poz., tab.
Twórcy
autor
- Instytut Medycyny Pracy im. prof. dr. med. Jerzego Nofera 91-348 Łódź ul. św. Teresy od Dzieciątka Jezus 8
autor
- Instytut Medycyny Pracy im. prof. dr. med. Jerzego Nofera 91-348 Łódź ul. św. Teresy od Dzieciątka Jezus 8
Bibliografia
- 1.ACGIH (2001) Documentation of the Threshold Limit Values for Chemical Substances and Biological Exposure Indices: Hydrazine. Cincinnati OH.
- 2.ACGIH (2013a) Guide to Occupational Exposure Values.
- 3.ACGIH (2013b) TLVs and BEIs Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices.
- 4.ACSH (2011) The Advisory Committee on Safety and Health at Work. Opinion Doc. 2011/12. Opinion on the approach and content of an envisaged proposal by the Commission on the amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 05/12/2012. EUROPEAN COMMISSION Employment, Social Affairs and Inclusion DG. Employment and Social Legislation, Social Dialogue. Health, Safety and Hygiene at Work [https://www.yumpu.com/en/document/ view/19542107/the-acsh-opinion-pdf-8096-kbeuropean- trade-union-institute- cyt. 2015-05-21].
- 5.Anderson D., Styles J.A. (1978) An evaluation of four short-term tests for detecting organic chemical carcinogens. Appendix 2. The bacterial mutation test. Br. J. Cancer 37, 924–930.
- 6.ATSDR (1997). Toxicological Profi le for Hydrazines. U.S. Department of Health & Human Services [http://www.atsdr.cdc.gov/toxprofi les/tp100.pdf].
- 7.Baker R.S.U., Mitchell G.A., Meher-Hornji K.M., Podobna E. (1983) Sensitivity of two Chinese hamster cel lines to SCE induction by a variety of chemical mutagens. Mutat. Res. 118, 103–116.
- 8.Becker R.A., Barrows L.R., Shank R.C. (1981) Methylation of liver DNA guanine in hydrazine hepatotoxicity: dose-response and kinetic characteristics of 7-methylguanine and of O6-methylguanine formation and persistence in rats. Carcinogenesis 2, 1181–1188.
- 9.Biancifi ori C. (1970) Hepatomas in CBA/Cb/Se mice and liver lesions in golden hamsters induced by hydrazine sulfate. J Nat Cancer Inst 44(4), 943– 953.
- 10.Blair I.A., Tinoco R.M., Brodie M.J. (1985) Plasma hydrazine concentrations in man after isoniazid and hydralazine administration. Hum. Toxicol. 4, 195– 202.
- 11.Bosan W.S., Shank R.C. (1983) Methylation of liver DNA guanine in hamster hiven hydrazine. Toxicol. Appl. Pharmacol. 79, 324–334.
- 12.Bosan W.S., Lambert C.E., Shank R.C. (1986) The role of formaldehyde in hydrazine-induced methylation of liver DNA guanine. Carcinogenesis 7, 413–418.
- 13.Bosan W.S., Shank R.C., McEwen I.D., Gaworski C.L., Newborne P.M. (1987) Methylation of DNA guanine during the course of induction of liver cancer in hamsters by hydrazine and dimethylnitrosamine. Carcinogenesis 8, 439–444.
- 14.Brandt B. (1960) Uber allergische Hauschaden durch Hydrazidsulfat. Dermatol. Wochenschr. 141, 376–381.
- 15.Centralny Rejestr Danych o Narażeniu na Substancje Chemiczne, ich Mieszaniny, Czynniki lub Procesy Technologiczne o Działaniu Rakotwórczym lub Mutagennym (2005-2011). Łódź, IMP [http://www.imp.lodz. pl/upload/centra/wykaz%20substancji%202015.pdf].
- 16.Drews A., Eversmann K., Fritze E. (1960) Oral poisoning with hydrazine. Med. Welt. 23, 1295–1279.
- 17.Duamin V.V., Denisov V.L., Andropova S.N., Maletin V.P. (1984) Infl uence of hydrazine on reproductive function of animals when administered in organisms by different routes. Gig. i Sanit. 9, 25–28.
- 18.EHC (1987) Environmental Health Criteria. Geneva, World Health Organization, nr 68 [http://www. inchem.org/documents/ehc/ehc/ehc68.htm].
- 19.Filov V.A., Gershanovich M.L., Danova L.A. (1995) Experience of the treatment with Sehydrin (Hydrazine Sulfate, HS) in the advanced cancer patients. Invest. New Drugs 13, 89–97.
- 20.Fitgerald B.E., Shank R.C. (1996) Methylation status of DNA cytosine during the course of induction of liver cancer in hamsters by hydrazine sulphate. Carcinogenesis 17, 2703–2709.
- 21.Fortney S.R. (1967) Effect of hydrazine on carbohydrate metabolism in vivo and in vitro. Aerospace Med. 38, 727–731.
- 22.Frost J., Hjorth N. (1959) Contact dermatitis from hydrazine hydrochloride in soldering fl ux. Cross sensitization to apressoline and isoniazid. Acta Derm. Venerolog. 39, 82–86.
- 23.Gershanovich M.L., Danova L.A., Ivin B.A. (1981) Results of clinical study on antitumor action of hydrazine sulfate. Nutr. Cancer 3, 7–12.
- 24.GIS (2014) Dane Stacji Sanitarno Epidemiologicznej. Główny Inspektorat Sanitarny [materiał niepublikowany].
- 25.Gershanovich M.L., Danova L.A., Ivin B.A. (1981) Results of clinical study on antitumor action of hydrazine sulfate. Nutr Cancer 3, 7–12.
- 26.GESTIS International Limit Values (2014) [http:// limitvalue.ifa.dguv.de/WebForm_ueliste2.aspx].
- 27.Gupta R.S., Goldstein S. (1981) Mutagen testing in the human fi broblast diphteria toxin resistance (HF Dipr) system [W:] Evaluation of short-term tests for carcinogens. Report of the International Collaborative Programme (Progress in Mutation Research, vol. 1) [Red.] F.J. de Serres, J. Ashby. Amsterdam, Elsevier, 614–625.
- 28.Harati Y., Niakan E. (1986) Hydrazine toxicity, pyridoxine therapy, and peripheral neuropathy. Ann. Intern. Med. 5, 728–729.
- 29.Haun C.C., Kinkhead E.R. (1973) Chronic inhalation toxicity of hydrazine. Springdield, VA, U.S. Department of Commerce, AMRL-TR-73-125 [cyt. Za EHC 1987].
- 30.IARC Monographs on the evaluation of cancerogenic risk of chemicals to humans. Reevaluation of some organic chemicals, hydrazine, and hydrogen peroxide (1999) vol. 71, Lyon, 991–1013.
- 31.IFA (2014) Gestis Substance Database. Hydrazine. Institut fűr Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung [http://gestis-en.itrust.de/ nxt/gateway.dll/gestis_en/000000.xml?f=templates$ fn=default.htm$3.0].
- 32.IRIS (2014) Integrated Risk Information System. Document Number: 0352. Hydrazine, Hydrazine sulfate [http://www.epa.gov/iris/subst/0352.htm cyt. 2015-05-20].
- 33.Ito K., Yamaamoto K., Kawanishi S. (1992) Manganese- mediated oxidative damage of cellular and isolated DNA by isoniazid and related hydrazines. Non-Fenton-type hydroxyl radical formation. Biochemistry 31, 11606–11613.
- 34.Kaneo Y., Iguchi S., Kubo H. (1984) Tissue distribution of hydrazine and its metabolites in rats. J. Pharmacobiodyn. 7, 556–562.
- 35.Kao Y.H., Chong C.H., Ng W.T., Lim D. (2007) Hydrazine inhalation hepatotoxicity. Occup Med 57, 535–537.
- 36.Keller W.C., Olson C.T., Back K.C. (1982) Evaluation of the embriotoxicyty of hydrazine in rats. AFAMRL-TR-82-29 (AD/119706). Air Force Aerospace Medicine Research Laboratory, Wright-Patterson Air Force Base, OH [cyt. za ACGIH 2001].
- 37.Kimball R.F. (1977) The mutagenicity of hydrazine and some of its derivatives. Mutat. Res. 39, 111–126.
- 38.Kirklin J.K., Watson M., Bondoc C.C., Burke J.F. (1976) Treatment of hydrazine-induced coma with pyridoxine. New Engl. J. Med. 294, 938–939.
- 39.Lee S.H., Aleyassine H. (1970) Hydrazine toxicity in pregnant rats. Arch. Environ. Health 21, 615–619.
- 40.List of MAK and BAT Values (2014) Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area Report 50. Deutsche Forschungsgemeinschaft authorized and signed by Professor Dr. Andrea Hartwig Chair of the Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Bonn. Weinheim, WILEY-VCH Verlag GmbH & Co. KGaA [http://onlinelibrary.wiley.com/ doi/10.1002/9783527682027.oth2/pdf].
- 41.Llewellyn B.M., Keller W.C., Olson C.T. (1986) Urinary metabolites of hydrazine in male Fischer 344 rats following inhalation or intravenous exposure. AAMRL-TR-86-025 [cyt. za ATSDR 1997].
- 42.Lyng R.D., Keller W.C., Back K.C. (1980) Effects of hydrazine on pregnant ICR mice. AFAMRL-TR-80-19 (AD/A084023). Air Force Aerospace Medicine Research Laboratory, Wright-Patterson Air Force Base, OH [cyt. za ACGIH 2001].
- 43.Mac Ewen W.D., Vernot E.H., Haun C.C., Kinkead E.R., Hall A. (1981) Chronic inhalation toxicity of hydrazine: Oncogenic effects. Air Force Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, Ohio. NTIS, Springfi eld, VA. [cyt.za IRIS 2014].
- 44.Mc Mahon R.E., Cline J.C., Thompson C.Z. (1979) Assay of 855 tests chemicals in ten tester strains using a new modifi cation of the Ames test for bacterial mutagens. Cancer Res. 39, 682–693.
- 45.Mac Rae W.D., Stich H.F. (1979) Induction of sister- chromatid exchanges in Chinese hamster ovary cells by thiol and hydrazine compounds. Mutat. Res. 68, 351–366.
- 46.Merck Index (1983) [Red.] M. Windholz. Merck & Co, 10. ed.
- 47.Morris J., Densem J.W., Walk N.J. (1995) Occupational exposure to hydrazine and subsequent risk of cancer. Occup. Environ. Med. 52, 43–45.
- 48.Noda A., Ishizawa M., Ohno K., Noda H. (1986) Relationship between oxidative metabolites of hydrazine and hydrazine-induced mutagenocity. Toxicol Lett. 31, 131–137.
- 49.Noda A., Sendo T., Ohno K. (1987) Metabolism and cytotoxicity of hydrazine in isolated rat hepatoMarek cytes. Chem Pharmacol. Bull. 35, 2538–2544.
- 50.Noda A., Noda H., Misaka A. (1988) Hydrazine radical formation catalyzed by rat microsomal NADPH-cytochrome P-450 reductase. Biochem. Biophys. Res. Commun. 153, 256–260.
- 51.NTP (1991) Chemical Repository. Hydrazine. Radian Corporation. Baza danych EXPUB. Expert Publishing LLC [http://www.expub.com/].
- 52.NTP (2011). Report on carcinogens, 12. ed. Hydrazine and hydrazine sulfate. Cas. Nos. 302-01-2 and 10034-93-2. Baza danych EXPUB, Expert Publishing LLC [http://www.expub.com/].
- 53.O’Leary J.F., Oikemus A. (1956) Treatment of hydrazine toxicity. Arch. Ind. Health 14, 569–570.
- 54.Parodi C.S., De Flora S., Cavanna M. (1981) DNA-damaging activity in vitro and bacterial mutagenicity of 16 hydrazine derivatives as related quantitatively to their carcinogenicity. Cancer Res. 41, 1469–1482.
- 55.Patrick R.L., Back E.C. (1965) Pathology and toxicology of repeated doses of hydrazine and 1,1-dimethylhydrazine in monkeys and rats. Ind. Med. Surg. 34, 430–435.
- 56.Perry P.E. , Thomson E.J. (1981) Evaluation of the sister chromatid exchange method in mammalian cells as a screening system for carcinogens [W:] Evaluation of short-term tests for carcinogens. Report of the International Collaborative Programme (Progress in Mutation Research, vol. 1) [Red.] F.J. de Serres, J. Ashby. Amsterdam, Elsevier, 561–569 [cyt. za EHC 1987].
- 57.Preece N.E., Nicholson J.K., Timbrell J.A. (1991) Identification of novel hydrazine metabolites by 15N-NMR. Biochem. Pharmacol. 9, 1319–1324.
- 58.Preece N.E., Forrow S., Ghatineh S., Langley G.C., Timbrell J.A. (1992) Determination of hydrazine in biofluids by capillary gas chromatography with nitrogen sensitive or mass spectrometric detection. J. Chromatogr. 573, 227–234.
- 59.Puchalska H. (1994) Hydrazyna. Podstawy i Metody Ochrony Środowiska Pracy 11, 7–34.
- 60.Reid F.J. (1965) Hydrazine Poisoning. Brit. Med. J. 20, 1246.
- 61.Ritz B., Morgenstern H., Froines J., Moncau J. (1999) Chemical exposures of rocket-engine test- -stand personel and cancer mortality in a cohort of aerospace workers. J. Occup. Environ. Med. 41, 154–161.
- 62.Ritz B., Zhao Y., Krishnadasan A., Kennedy N., Morgenstern H. (2006) Estimated effects of hydrazine exposure in cancer incidence and mortality in aerospace workers. Epidemiology 17, 154–161.
- 63.Rogan E.G., Walker B.A., Gingell R., Nagel D.L., Toth B. (1982) Microbal mutagenicity of selected hydrazines. Mutat. Res. 102, 413–424.
- 64.Rozporządzenie Parlamentu Europejskiego i Rady (WE) nr 1272/2008 z dnia 16 grudnia 2008 r. w sprawie klasyfikacji, oznakowania i pakowania substancji i mieszanin, zmieniającego i uchylającego dyrektywy 67/548/EWG i 1999/45/WE oraz zmieniającego rozporządzenie (WE) nr 1907/2006. Dz. Urz. UE L 353 z 31 grudnia 2008 r. z późn. zm.
- 65.Rozporządzenie Ministra Zdrowia z dnia 24 lipca 2012 r. w sprawie substancji chemicznych, ich mieszanin, czynników lub procesów technologicznych o działaniu rakotwórczym lub mutagennym w środowisku pracy. DzU poz. 890.
- 66.Runge-Morris M.A., Iacob S., Novak R.F. (1988) Characterization of hydrazine-stimulated proteolysis in human erythrocytes. Toxicol. Appl. Pharmacol. 94, 414–426.
- 67.SCOEL (2010) Recommendation from the Scientifi c Committee on Occupational Exposure. Limits for hydrazine. SCOEL/SUM/164.
- 68.Sin J.F., Bean CV.L., Dysart G.R., Taylor V.I., Bradley M.O. (1983) Evaluation of the alkaline elution/rat hepatocyte assay as a predictor of carcinogenic/mutagenic potential. Mutation Res. 113, 357–391.
- 69.Sinha B.K. (1987) Activation of hydrazine derivatives to free radicals in the perfused rat liver. A spin-trapping study. Biochim. Biophys. Acta 924, 261–269.
- 70.Smith E.B., Clark D.A. (1972) Absorption of hydrazine through canine skin. Toxicol. Appl. Pharmacol. 21, 186–193.
- 71.Sotaniemi E., Hirvonen J., Isomaki H., Takkunen J., Kaila J. (1971) Hydrazine toxicity in the human. Report of the fatal case. Ann. Clin. Res. 3, 30–33.
- 72.Sotomayer R.E., Chauhan P.S., Ehling U.H. (1982) Induction of unscheduled DNA synthesis in the germ cells of male mice after treatment with hydrazine or procarbazine. Toxicology 25, 201–211.
- 73.Speit G., Wick C., Wolf M. (1980) Induction of sister chromatyd exchanges by hydroxylamine, hydrazine and isoniazid and their inhibition by cysteine. Human Genet. 52, 155–158.
- 74.Springer D.I., Krivak B.M., Broderick D.I. (1981) Metabolic fate of hydrazine. J. Toxicol. Environ. Health 8, 21–29.
- 75.Steinhoff D., Mohr U. (1988) The question of carcinogenic effects of hydrazine. Exp. Pathol. 33, 133–143.
- 76.Steinhoff D., Mohr U., Schmidt W.M. (1990) The question of carcinogenic effects of hydrazine. Evaluation on the basis of new experimental results. Exp. Pathol. 39, 1–9.
- 77.Szymańska J.K., Szymczak W. (2012) Hydrazyna. Wytyczne Szacowania Ryzyka 1, 97–122.
- 78.Timbrell J.A., Scales M.D.C., Streeter A.J. (1982) Studies on hydrazine hepatotoxicity. 2. Biochemical fi ndings. J Toxicol. Environ. Health 10, 955–968.
- 79.Timbrell J., Harland S. (1979) Identifi cation and quantitation of hydrazine in the urine of patients treated with hydrazine. Clin. Pharmacol. Ther. 26(1), 81–88.
- 80.Tosk J., Schemeltz I., Hoffman D. (1979) Hydrazines as mutagens in a histidine-requiring auzotroph of Salmonella typhimurium. Mutat. Res. 66, 247–252.
- 81.Toth B. (1969) Lung tumor induction and inhibition of breast adenocarcinomas by hydrazine sulfate in mice. J. Natl. Cancer Inst. 42, 469–475.
- 82.Van Delft J.H., Steenwinkel M.J., de Groot A.J., van Zeeland A.A., Eberle-Adamkiewicz G., Rajewski M.F., Thomale J., Baan A.A. (1997) Determination of N7- and 06 methylguanine in rat liver DNA after oral exposure to hydrazine by use of immuno-chemical and electrochemical detection methods. Fundam. Appl. Toxicol. 35, 131–137.
- 83.Vernot E.H., MacEwen J.D., Bruner R.H., Haun C.C., Kinkhead E.R., Prentice D.E., Hubbard G.B., Young J.T. (1985) Long-term inhalation toxicity of hydrazine. Fund. Appl. Toxicol. 5, 1050–1064.
- 84.Von Wright A., Tikkanen L. (1980) Hydrazine and methylhydrazine as recA+- independent mutagens in Escherichia coli. Mutat. Res. 71, 269–271.
- 85.Wald N., Boreham J., Doll R. (1984) Occupational exposure to hydrazine and subsequent risk of cancer. Brit. J. Ind. Med. 41, 31–34.
- 86.Weber W. (1984) Acetylation pharmacogenetics: experimental models for human toxixity. Fed. Proc. 43(8), 2332–2337.
- 87.Wheeler C.E., Penn S.R., Cawley E.P. (1965) Dermatitis from hydrazine solder flux. Arch. Dermatol. 91, 235–239.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-a7c3dfe0-d42f-4139-a6dc-5a987c19cf05