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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 />

cerebellum), dopamine (corpus striatum, hypothalamus) and<br />

serotonin (hypothalamus, midbrain, corpus striatum, cerebral<br />

cortex, medulla oblongata) levels; also increased levels of<br />

catecholamine metabolites indicating induction of synthesis<br />

and catabolism of monoamine transmitters by benzene<br />

ingestion.<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

Test substance: purity 99.9%<br />

06–JAN–1997 (535)<br />

Type: Toxicokinetics<br />

Remark: In summary, benzene is well absorbed in humans and<br />

experimental animals after oral and inhalation exposures,<br />

but in humans dermal absorption is poor. Approximately 50%<br />

absorption occurs in humans during continuous exposures to<br />

163–326 mg/m3 for several hours. After a 4–hr exposure to<br />

170–202 mg/m3, retention in the human body was approximately<br />

30%, with 16% of the retained dose having been excreted as<br />

unchanged benzene in expired air. Women may retain a<br />

greater percentage of inhaled benzene than men. Benzene<br />

tends to accumulate in tissues containing high amounts of<br />

lipids, and it crosses the placenta. Benzene is eliminated<br />

by exhalation of unmetabolized benzene from the lungs and by<br />

metabolism in the liver (lesser extend by bone marrow) and<br />

following excretion via urine.<br />

Reliability: 4 (validity cannot be judged)<br />

data from secondary literature, but validated (WHO, 1993) by<br />

an expert group (WHO task group)<br />

Source: Deutsche Shell Chemie GmbH Eschborn<br />

06–JAN–1997 (874) (1252)<br />

Type: Toxicokinetics<br />

Remark: method: 6 male and 6 female human volunteers inhaled 52–62<br />

ppm benzene for 4 h; benzene concentration was measured in<br />

1–h–intervals by GC and spectrophotometry.<br />

results: retention decreased with duration of exposure and<br />

reached a constant level (30%, estimated) after 2 h (no<br />

differences between men and women); absorption was greatest<br />

during 1st 5 minutes of exposure; after 4 h 46.9% of the<br />

dose was taken up by the subjects, 16.8% was excreted as<br />

unchanged benzene in the expired air; metabolites of benzene<br />

were excreted in the urine mainly in form of sulfate and<br />

glucuronide conjugates of phenol.<br />

Reliability: 2 (valid with restriction)<br />

Comparable to guideline study with acceptable restrictions<br />

no data about test substance<br />

Source: Deutsche Shell Chemie GmbH Eschborn ;German rapporteur<br />

Flag: Risk Assessment<br />

14–SEP–2000 (838) (839)<br />

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

– 831/957 –

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