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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 />

thereport), a statistically significant excess of all<br />

leukaemias was found for employees experiencing the highest<br />

number (more than 40) of peaks. There were 5 total<br />

leukaemias versus 1.25 expected [SMR = 4.0, 95% CI = (1.3,<br />

9.2)]. The SMR for AML in these workers was slightly<br />

higher(4.8 based on two cases), but was not statistically<br />

significant.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

German rapporteur<br />

Flag: Risk Assessment<br />

07–JUL–2005 (565)<br />

Remark: In the present investigation, all cohort studies of<br />

petroleum workers in the United States and the United<br />

Kingdom were combined into a single database for<br />

cell–type–specific leukemia analysis. The majority of<br />

theseworkers were petroleum refinery employees, but<br />

production, pipeline, and distribution workers in the<br />

petroleum industrywere also included. The combined cohort<br />

consisted of 208,741 petroleum workers employed between<br />

1937<br />

and 1989. Cell–type–specific leukemia risks were<br />

calculated<br />

using a meta–analysis procedure appropriate for combining<br />

occupational cohort studies. These risks were expressed in<br />

terms of cell–type–specific leukemia standardized mortality<br />

ratios (meta–SMRs). The meta–SMR for acute myelogenous<br />

leukemia was 0.96. The lack of an increase of acute<br />

myelogenous leukemia was attributed to the low levels of<br />

benzene exposure in the petroleum industry, particularly in<br />

comparison to benzene exposure levels in some previous<br />

studies of workers in other industries, who had been found<br />

to experience increased risk of acute myelogenous leukemia<br />

(AML). Using the Rinsky et al. (1987) data from the<br />

Pliofilm cohort, exposure–response analyses for AML<br />

indicated no increase for cumulative exposures below 200<br />

ppm–years (SMR = 0.91). Had other more realistic higher<br />

exposure estimates been used, the observed AML threshold<br />

would have been higher. No increase in chronic<br />

myelogenous,acute lymphocytic, or chronic lymphocytic<br />

leukemias was found in petroleum workers (meta–SMRs of<br />

0.89,<br />

1.16, and 0.84, respectively). Meta–analyses restricted to<br />

refinery studies or to studies with at least 15 years of<br />

follow–up yielded similar results. The findings of the<br />

present investigation are consistent with those from<br />

several<br />

recent case–control studies.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

German rapporteur<br />

Flag: Risk Assessment<br />

07–JUL–2005 (1277)<br />

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

– 647/957 –

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