2-Toliloamina : dokumentacja proponowanych dopuszczalnych wielkości narażenia zawodowego

• Autorzy: Pałaszewska-Tkacz A. , Świdwińska-Gajewska A , Czerczak S.

Identyfikatory

DOI

10.5604/01.3001.0012.4768

Warianty tytułu

EN

o-Toluidine : documentation of proposed values of occupational exposure limits (OELs)

• Języki publikacji: PL

Abstrakty

PL

2-Toliloamina jest substancją wielkotonażową stosowaną w przemyśle: gumowym, barwiarskim, farmaceutycznym oraz do produkcji herbicydów i jako surowiec do przemysłowej produkcji innych związków chemicznych. Szacowana liczba osób zawodowo narażonych na 2-toliloaminę w UE wynosi 5 500, z czego ponad połowa jest zatrudniona w: przemyśle chemicznym, przy produkcji włókien chemicznych oraz produktów gumowych. W warunkach narażenia zawodowego 2-toliloamina wchłania się do organizmu drogą inhalacyjną i przez skórę i niezależnie od drogi narażenia związek ten jest wydalany głównie z moczem. Wśród skutków ostrego inhalacyjnego narażenia na duże stężenia 2-toliloaminy (> 25 mg/m3) są opisywane: podrażnienie górnych dróg oddechowych, oczu i skóry objawiające się uczuciem pieczenia twarzy, oczu, gardła oraz kaszlem, skrócenie oddechu, osłabienie, nudności, wymioty, bóle i zawroty głowy, szum w uszach, methemoglobinemia, hematuria i zaburzenia czynności nerek oraz krwotoczne zapalenie pęcherza moczowego. W badaniach epidemiologicznych analizowano najczęściej grupę substancji, jaką są aminy aromatyczne (w tym 2-toliloamina). Dostępne dane dotyczą głównie narażenia w przemyśle barwiarskim oraz gumowym. Jako skutki narażenia przewlekłego opisywano: methemoglobinemię, hematurię oraz uszkodzenie nabłonka pęcherza moczowego z czasem prowadzące do rozwoju nowotworów złośliwych tego narządu. Działanie rakotwórcze 2-toliloaminy zostało również potwierdzone w badaniach przeprowadzonych na zwierzętach doświadczalnych, w tym na szczurach i myszach. Narażenie drogą pokarmową na 2-toliloaminę wywoływało nowotwory pęcherza moczowego, przede wszystkim u samic szczura, w mniejszym stopniu u samców. U samic szczura F344, narażanych wraz z paszą na 2-toliloaminę, obserwowano statystycznie znamienny, zależny od dawki, wzrost częstości występowania raka z komórek przejściowych pęcherza moczowego. Ponadto u myszy i szczurów występowały: włókniaki i włókniakomięsaki w tkance podskórnej, naczyniaki i naczyniakomięsaki zlokalizowane w jamie brzusznej i pęcherzu moczowym, międzybłoniaki różnych narządów, mięsakonaczyniaki w różnych narządach, raki z komórek wątrobowych i gruczolaki. U zwierząt doświadczalnych 2-toliloamina wykazuje umiarkowaną toksyczność ostrą: wartości LD50 dla podania dożołądkowego mieszczą się w przedziale 670 ÷ 2 951 mg/kg mc. W badaniach toksyczności ostrej u szczurów narażanych inhalacyjnie obserwowano: sinicę, skurcze i drżenia mięśni, trudności w oddychaniu, czerwono-brązowy wyciek z nosa, zmętnienie rogówki, spadek masy ciała, obniżenie temperatury ciała, ospałość, skrajne wyczerpanie. Opisane w literaturze skutki narażenia podprzewlekłego i przewlekłego zwierząt doświadczalnych na 2-toliloaminę obejmują zmiany w obrębie: śledziony, układu krwiotwórczego oraz nerek i pęcherza moczowego. Na podstawie wyników większości badań mutagenności w układach bakteryjnych nie potwierdzono działania mutagennego 2-toliloaminy, jedynie w nielicznych pracach opisywano wynik dodatni testów po aktywacji metabolicznej. Zarówno w badaniach w warunkach in vitro, jak i in vivo, potwierdzono natomiast indukcję uszkodzeń DNA przez 2-toliloaminę. 2-Toliloamina ma klasyfikację zharmonizowaną w UE jako substancja rakotwórcza kategorii zagrożenia 1.B z przypisanym zwrotem H350 – może powodować raka. Eksperci SCOEL zaliczyli ją do grupy A kancerogenów, czyli substancji rakotwórczych mających właściwości genotoksyczne. W Niemczech, w DFG, zaliczono 2-toliloaminę do kategorii 1. kancerogenów, czyli do sub¬stancji, które powodują raka u człowieka i substancji, co do których przyjmuje się, że znacząco wpływają na ryzyko wystąpienia raka. W IARC zaklasyfikowano ją do grupy 1., czyli związków o potwierdzonym działaniu rakotwórczym na ludzi. Na podstawie ilościowej oceny ryzyka wystąpienia nowotworu w wyniku narażenia zawodowego oszacowano, że w przy 40-letnim okresie narażenia na 2-toli¬loaminę o stężeniu 1 mg/m3 dodatkowe ryzyko wystąpienia raka pęcherza moczowego wynosi 2,4 ÷ 3,1 10-4 (w zależności od metody szacowania). Wartości dopuszczalnych stężeń 2-toliloaminy obowiązujące w krajach członkowskich UE oraz na świecie wynoszą: 0,5 ÷ 0,9; 4,5 ÷ 8,8 oraz 22 mg/m³. W Polsce obowiązująca wartość NDS wynosi 3 mg/m3. W SCOEL nie zaproponowano wiążącej wartości BOELV, uznając 2-toliloaminę za genotoksyczny kancerogen. W dyrektywie Parlamentu Europejskiego i Rady (UE) 2017/2398 z dnia 12 grudnia 2017 r. zmieniającej dyrektywę 2004/37/WE w sprawie ochrony pracowni¬ków przed zagrożeniem dotyczącym narażenia na działanie czynników rakotwórczych lub mutagenów pod¬czas pracy przyjęto stężenie 0,5 mg/m3 (0,1 ppm) jako wartość wiążącą dla 2-toliloaminy (na podstawie: ana¬lizy socjoekonomicznej, oceny ryzyka środowiskowego oraz ryzyka wystąpienia raka pęcherza moczowego u pracowników narażonych zawodowo). Zaproponowano zmniejszenie wartości NDS 2-toliloaminy do poziomu 0,5 mg/m3, co wpłynie na blisko dziesięciokrotne zmniejszenie ryzyka zachorowania na raka pęcherza moczowego pracowników. Ponadto, zgodnie z danymi Głównego Inspektoratu Sanitarnego (GIS), w Polsce w latach 2015-2016 nie stwierdzono narażenia na 2-toliloaminę o stężeniach > 3 mg/m3 oraz > 1,5 mg/m3 (0,5 wartości NDS), natomiast w warunkach narażenia na stężenia z zakresu 0,3 ÷ 1,5 mg/m3 (0,1 ÷ 0,5 wartości NDS) pracowało jedynie kilkanaście osób. Nie ma podstaw do ustalenia wartości najwyższego dopuszczalnego stężenia chwilowego (NDSCh). Jako wartość dopuszczalnego stężenia w materiale biologicznym (DSB) 2-toliloaminy zaproponowano pozostawienie jak dotychczas 2% poziomu MetHb we krwi. Normatyw oznakowano: „skóra” (wchłanianie substancji przez skórę może być tak samo istotne, jak przy narażeniu drogą oddechową) oraz „Carc. 1B” (substancja rakotwórcza kategorii zagrożenia 1.B).

EN

o-Toluidine is a substance produced in large amounts and used in rubber, dyeing and pharmaceutical industries and in the production of herbicide and other chemical compounds. The estimated number of people occupationally exposed to o-toluidine in EU is 5 500, half of them is employed in chemical industry in the production of chemical fibers and rubber products. In the conditions of occupational exposure, o-toluidine is absorbed by skin and by inhalation. Regardless of route of exposure this compound is excreted in urine. The effects of acute inhalation exposure to high concentrations (> 25 mg/m3 ) of o-toluidine are irritation of upper respiratory tract, irritation of eyes and skin, which is manifested by face, eyes and pharynx burning, cough, shortness of breath, weakness, nausea, vomit, headache and dizziness, tinnitus, methemoglobinemia, hematuria and hemorrhagic cystitis. In epidemiological studies, the mostly analyzed group of substances was aromatic amines (including o-toluidine). Available data mainly refer to exposure in dyeing and rubber industries. Described effects of chronic exposure are methemoglobinemia, hematuria and damage of bladder epithelium leading to malignant tumor of this organ. Carcinogenicity of o-toluidine was confirmed in tests on experimental animals, including rats and mice. Oral exposure to o-toluidine results in bladder cancer, primarily in female rats, to a lesser extent in male rats. In female rats F344 exposed to o-toluidine with feed, increase of the incidence of cancer from the bladder transitional cells was observed. Furthermore, in mice and rats fibromas and fibrosarcomas in subcutaneous tissue, angiomas and angiosarcomas in abdominal cavity and bladder, mesotheliomas of various organs, angiosarcomas in various organs, hepatocellular carcinomas and adenomas were observed. In experimental animals, o-toluidine exhibits moderate acute toxicity, LD50 values for intragastric administration are within the range 670 – 2951 mg/kg bw. In acute toxicity studies, rats exposed by inhalation to o-toluidine had cyanosis, contractions and muscle tremor, difficulty in breathing, red-brown rhinorrhea, corneal opacification, body weight loss, body temperature decrease, lethargy and extreme exhaustion. The effects of subchronic and chronic exposure of experimental animals to o-toluidine described in the literature include changes in the spleen, hematopoietic system, kidneys and bladder. Most of the mutagenicity tests in bacterial systems do not confirm mutagenicity of o-toluidine. A few works only described positive test result after metabolic activation. Both in vitro and in vivo studies confirmed induction of DNA damage by o-toluidine. o-Toluidine has harmonized classification in the EU as a category 1B carcinogen with assigned phrase H350 – may cause cancer. SCOEL experts classified it to group A of carcinogens, which means carcinogens with genotoxic properties. In Germany, DFG has ranked o-toluidine into category 1 of carcinogens, so substances that cause cancer in humans and substances that are believed to significantly affect the risk of cancer. IARC classified it into group 1, compounds with confirmed human carcinogenicity. On the basis of a quantitative assessment of the risk of cancer as a result of occupational exposure, it has been estimated that at a 40-year exposure period to o-toluidine at a concentration of 1 mg/m3 , the additional risk of bladder cancer ranges from 2.4 – 3.1 • 10-4 (depending on the estimation method). The values of the determining exposure limits of o-toluidine applicable in the EU member states and in the world are 0.5 – 0.9 mg/m3 ; 4.5–8.8 mg/m3 and 22 mg/m3 . In Poland, the applicable OEL value is 3 mg/m3 . In SCOEL, no BOELV had been proposed, considering o-toluidine as a genotoxic carcinogen. Directive 2017/2398 of the European Parliament and of the Council (EU) of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work, a concentration of 0.5 mg/m3 was adopted (0.1 ppm) as a binding value for o-toluidine (based on socio-economic analysis, environmental risk assessment and risk of bladder cancer in professionally exposed workers). It has been proposed to reduce the OEL value of o-toluidine to 0.5 mg/m3 , which will affect a nearly tenfold reduction in the risk of bladder cancer workers. In addition, according to CSI (Chief Sanitary Inspectorate) data in Poland, no exposure to o-toluidine in concentrations > 3 mg/m3 and > 1.5 mg/m3 (0.5 OEL values) have been found in years 2015–2016, while in conditions of exposure to concentrations from within the range of 0.3 – 1.5 mg/m3 (0.1 – 0.5 of the OEL value), a dozen or so people only worked. There is no basis for determining the short-term exposure limit value (STEL). As a value of biological exposure index (BEI) of o-toluidine, it has been proposed to leave 2% level of the MetHb in the blood. The standard was labeled “skin” (the absorption of substances through the skin may be as important as in inhalation) and “Carc. 1B” (carcinogenic substance of category 1B).

Słowa kluczowe

PL

2-toliloamina; narażenie zawodowe; toksyczność; NDS

EN

o-toluidine; occupational exposure; toxicity; MAC-TWA

• Wydawca: Centralny Instytut Ochrony Pracy - Państwowy Instytut Badawczy
• Czasopismo: Podstawy i Metody Oceny Środowiska Pracy
• Rocznik: 2018
• Tom: Nr 3 (97)
• Strony: 77--117
• Opis fizyczny: Bibliogr. 186 poz., rys., tab.

Twórcy

autor

Pałaszewska-Tkacz A.

• Instytut Medycyny Pracy im. prof. dr. med. Jerzego Nofera 91-348 Łódź ul. św. Teresy od Dzieciątka Jezus 8

autor

Świdwińska-Gajewska A

• Instytut Medycyny Pracy im. prof. dr. med. Jerzego Nofera 91-348 Łódź ul. św. Teresy od Dzieciątka Jezus 8

autor

Czerczak S.

• Instytut Medycyny Pracy im. prof. dr. med. Jerzego Nofera 91-348 Łódź ul. św. Teresy od Dzieciątka Jezus 8

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Uwagi

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).