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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 />

average (LTA) exposure concentrations, rather than the<br />

estimated cumulative exposure of benzene. A dose rate<br />

effect is defined as an effect which primarily relies on<br />

exposure concentration, above that which would be predicted<br />

by the simple mathematical product of concentration X time.<br />

The three sets of LTA exposure estimates developed by<br />

previous authors (Rinsky et al., 1981; Crump & Allen, 1984;<br />

Paustenbach et al., 1992) were used in the study. Subsets<br />

of Pliofilm employees always exposed to less than or equal<br />

to specific concentration of benzene were examined. The<br />

results suggest that (a) AMML risk is shown only above a<br />

critical concentration of benzene exposure, measured as a<br />

long term average and experienced for years, (b) the<br />

critical concentration is between 160 and 192 mg/m3 (50 and<br />

60 ppm) using exposure estimates from three previous<br />

exposure assessments, (c) using the lowest exposure<br />

estimates (Rinsky et al., 1981), there was no suggestion of<br />

excess risk for workers who experienced LTA concentrations<br />

over their career of 64 mg/m3 (20 ppm) or below, and (d)<br />

risks for total leukaemia are driven by risks for AMML,<br />

suggesting that AMML is the cell type related to benzene<br />

exposure.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

06–JAN–1997 (1023)<br />

Remark: This study of 33,815 men, who first started work in the<br />

rubber industry between 1 January 1946 and 31 December<br />

1960,followed their mortality experience up to 31 December<br />

1975 to ascertain the number of deaths attributable to<br />

malignant disease and to compare these with the expected<br />

number calculated from the published mortality rates<br />

applicable to the male population of England and Wales and<br />

Scotland. No quantitative estimates of benzene exposures<br />

were available. A statistically significant excess of both<br />

lung and stomach cancer mortality was observed. A small<br />

excess of oesophageal cancer was also observed in both the<br />

tire and general rubber goods manufacturing sectors.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

06–JAN–1997 (870)<br />

Remark: This is a prospective cohort study of approximately 11,000<br />

male and 600 female employees in the Australian petroleum<br />

industry who had worked at least 5 years in 1981–1983.<br />

Jobswere coded according to classifications developed by<br />

the<br />

American Petroleum Institute to assess potential exposure.<br />

However, there were no quantitative exposure data available<br />

on benzene or other exposures; potential exposures were<br />

ranked on a qualitative scale from one to four. Deaths<br />

fromlympho–hematopoietic cancers (LHC) were greater than<br />

expected based on the australian national population.<br />

(Standardized Mortality Ratio [SMR] = 138; 95% Confidence<br />

Interval [CI] = 63–263). Incident cancers in this category<br />

were significantly elevated (Standardized Incidence Ratio<br />

[SIR] = 204; 95% CI = 125–315). All leukemia cell types<br />

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

– 696/957 –

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