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Appendix D - Dossier (PDF) - Tera

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date: 20–JUL–2005<br />

5. Toxicity Substance ID: 71–43–2<br />

______________________________________________________________________________<br />

Remark: A retrospective cohort study was carried out in 1982–1983<br />

among 28,460 benzene–exposed workers (15,643 males, 12,817<br />

females) from 233 factories and 28,257 control workers<br />

(16,621 males, 12,366 females) from 83 factories in 12<br />

largecities in China. All–cause mortality was<br />

significantly<br />

higher among the exposed (265.46/100,000 person–years) than<br />

among the unexposed (139.06/100,000 person–years), as was<br />

mortality from all malignant neoplasms (123.21/100,000<br />

versus 54.7/100,000, respectively). For certain cancers,<br />

increased mortality was noted among benzene–exposed males<br />

incomparison with that among unexposed males; the<br />

standardizedmortality ratios (SMR) were elevated for<br />

leukemia (SMR = 5.74), lung cancer (SMR = 2.31), primary<br />

hepatocarcinoma (SMR = 1.12), and stomach cancer (SMR =<br />

1.22). However, no analyses by duration of benzene<br />

exposure<br />

were performed for lung cancer, primary hepatocarcinoma, or<br />

stomach cancer to determine their relationship with<br />

benzene.<br />

For females, only leukemia occurred in excess among the<br />

exposed. Risk ofleukemia rose as duration to exposure to<br />

benzene increased up to 15 years, and then declined with<br />

additional years of exposure. Leukemia occurred among some<br />

workers with as little as 6 to 10 ppm average exposure and<br />

50 ppm–years (or possibly less) cumulative lifetime<br />

exposure<br />

(based on all available measurements for the exposed work<br />

units). Among the 30 leukemia cases identified in the<br />

exposed cohort, the proportion of subjects with acute<br />

lymphocytic leukemia was substantially lower and the<br />

proportion with acute nonlymphocytic leukemias was higher<br />

in<br />

the general population. During 1972 to 1981, the annual<br />

incidence of leukemia ranged from 5.83 to 28.33 per 100,000<br />

with higher rates occurring in the interval 1977 to 1981<br />

than in the earlier years of the study period.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

German rapporteur<br />

Flag: Risk Assessment<br />

07–JUL–2005 (1300)<br />

Remark: This is a case–control study of leukemia in relation to<br />

quantitative estimates of benzene exposure among petroleum<br />

distribution workers. There were 90 leukaemia cases and<br />

354controls from a previously studied United Kingdom<br />

petroleum worker population (Rushton, 1993). Exposure<br />

assessment was modelled after the Canadian effort<br />

(Armstrong<br />

et al., 1996). Leukaemia cell type information was obtained<br />

through death certificates and a cancer registration<br />

system.<br />

Benzene exposure concentrations were similar to the<br />

Canadian study, though slightly lower. Work history<br />

information was not as complete as the Canadian study, and<br />

<strong>Appendix</strong> D: Benzene SIDS <strong>Dossier</strong><br />

– 648/957 –

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