Cyclophosphamide. Documentation of proposed values of occupational exposure limits (OELs)
Journal Title: Podstawy i Metody Oceny Środowiska Pracy - Year 2015, Vol 31, Issue 1
Abstract
Cyclophosphamide (monohydrate) is a fine white crystalline odorless powder The sub-stance liquefies and becomes an oily semisolid mass when water is removed. It darkens on exposure to light. Cyclophosphamide an antineoplastic and immunosuppressant agent. It is used to treat malignant lymphoma, multiple myeloma, leukemia, breast and ovarian cancer, neuroblastoma and malignat neoplasms of the lung. Cyclophosphamide is also used as an immunosup-pressive agent to treat autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis and nephrotic syndrome (a kidney disorder) in children. It is increasingly being used as an inmunosuppressive agent following organ (kidney, bone marrow) transplantation. The drug may be administered orally in the form of tablets or intravenously following dissolution ex tempore in aqua for injections. It may also be used for perfusion of cancer-affected organs. In chemotherapy, it may be used alone, but more frequently is used concurrently or sequentially with other anticancer drugs. Cyclophosphamide has an influence on reproducibility in humans both during treatment and immediately afterwards. It causes fertility impairment and menstrual disorders. Cyclophosphamide is teratogenic to many animal species including rats, mice, rabbits and primates. It is responsible for a variety of muscu-loskeletal and other malformations and an in-creased number of resorptions, The type and frequency of malformations are strictly dose- and time-dependent. It is harmful to embryos and may lead to abortions. Exposure to cyclo-phosphamide in the first trimester of pregnancy may cause numerous congenital anomalies in fetuses, musculoskeletal malformations and deformations of limbs.Cyclophosphamide may be absorbed by inhalation, ingestion, from skin contact or from peritoneum. In the case of occupational exposure of health professionals, skin is considered the main route of exposure.Both in Poland and in other countries, neither occupational exposure level (OEL) in work-place air nor biological exposure index (BEI) has been established for occupational exposure to cyclophosphamide.The proposed OEL value for cyclophospha-mide has been derived from its carcinogenicity to laboratory animals, namely from a cancer slope factor (CSF) of 0.57 (mg/kg/day)–1 for bladder cancer, calculated from lifetime oral exposure of rats. The mean dose for 1 ∙ 10-4 excess lifetime cancer risk would be 1.754 ∙ 10-4 (mg/kg/day)–1, which in the condition of oc-cupational inhalation exposure is equivalent to air concentration 0.01 mg/m3 and this value is proposed as Time Weighted Average (TWA) OEL. The proposed OEL should protect em-ployees against leukemia and reproductive toxicity, too. The proposed biological exposure index (BEI) is 1 μg of cyclophosphamide in a 24-hr urine sample. There are no grounds for es-tablishing short-term exposure limit (STEL).Labelling the substance with “Carc. 1A” (car-cinogen category 1A), “Skóra” (substance can penetrate skin) and “Ft” (substance harmful to fetus) has been proposed.
Authors and Affiliations
Jan Gromiec
Keywords
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- EP ID EP81573
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