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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 />

and lymphocyte counts were depressed at 25 ppm and higher.<br />

No effect on the granulocytes was seen in all dose groups.<br />

Hemosiderin deposits in the spleen were reported in exposed<br />

animals, however no exact data are available.<br />

Source: German Rapporteur<br />

Flag: Risk Assessment<br />

06–JUL–2005 (261)<br />

Species: mouse Sex: male<br />

Strain: other: C57B1/6J and Swiss Webster<br />

Route of administration: inhalation<br />

Exposure period: 2 wk<br />

Frequency of treatment: 6 h/d, 4 d/wk<br />

Doses: 300 ppm (960 mg/m³)<br />

Control Group: yes<br />

LOAEL: 300 ppm<br />

Method: other<br />

Method: Male mice of each strain were exposed to 300 ppm benzene<br />

(960 mg/m³) for 6 hours per day, 4 days per week, for 2<br />

weeks.<br />

Result: Indicating strain–specific differences in the response to<br />

benzene, susceptiblity was higher in Swiss Webster mice than<br />

in C57B1/6J mice. They had reduced numbers of bone marrow<br />

cells and a reduced development of CFU–E (colony–forming<br />

unit–erythroid) with a more severe reduction in the Swiss<br />

Webster mice.<br />

Source: German Rapporteur<br />

Flag: Risk Assessment<br />

25–OCT–2000 (822)<br />

Species: mouse Sex: male<br />

Strain: other: C57B1/6<br />

Route of administration: inhalation<br />

Exposure period: up to 6 wk<br />

Frequency of treatment: 6 h/d, 5 d/wk<br />

Doses: 1000, 2000, 4000 ppm<br />

Control Group: yes<br />

LOAEL: 1000 ppm<br />

Method: other<br />

Method: 6 males/group<br />

Result: Intermittent exposures of 6 males/group on 5 days per week,<br />

6 hr/day for up to 6 weeks resulted in a<br />

concentration–related leukopenia at dosages of 1000, 2000,<br />

and 4000 ppm. Decreased numbers of white blood cells were<br />

evident on the third day and reached the minimal number by<br />

the 5th or 6th day of exposure. Mortality from continuouing<br />

the treatment up to 6 weeks was negligible. Mice of the 4000<br />

ppm group experienced tremulousness and were nearly<br />

immobilized during the 6–h exposure. Animals recovered<br />

quickly after the return to room air. Differential blood<br />

counts performed on the high dose animals after counts<br />

stabilized during treatment revealed decreased numbers of<br />

lymphocytes (1.34x versus 5.94x10³/cells/µl in controls) and<br />

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

– 358/957 –

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