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AMMONIUM SULFATE CAS N°: 7783-20-2

AMMONIUM SULFATE CAS N°: 7783-20-2

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OECD SIDS<br />

<strong>AMMONIUM</strong> <strong>SULFATE</strong><br />

5. TOXICITY ID: <strong>7783</strong>-<strong>20</strong>-2<br />

DATE: 18.04.<strong>20</strong>06<br />

- Morphometric analyses were performed on lungs of rats<br />

exposed to purified air or to the high concentration, and<br />

included measurements of the thickness and cellularity of the<br />

alveolar wall, alveolar chord lengths and alveolar<br />

cross-sectional diameters.<br />

- Macrophage function analysis: Bronchoalveolar lavage (BAL)<br />

was performed on 12 rats per group to obtain macrophages for<br />

immunological testing and proteins for assessment of<br />

epithelial permeability. Changes in functional characteristics<br />

of alveolar macrophages were quantified by a rosette assay for<br />

determining Fc receptor binding capacity for sheep red blood<br />

cells, and by determination of the production of superoxide<br />

anion during respiratory burst activity.<br />

- Changes in airway permeability: permeability was determined<br />

by measurement of albumin concentrations in the BAL fluid.<br />

- Further exploratory endpoints that were measured were:<br />

determination of the numbers of goblet cells in the<br />

respiratory epithelium, releases of the inflammatory mediators<br />

prostaglandin E2 (PGE2) and leukotriene B4 (LTB4), and<br />

measurements of respiratory frequency and tidal volume during<br />

exposure.<br />

STATISTICAL METHOD: one-way or two-way analyses of variance,<br />

as appropriate. Tukey multiple comparison test for differences<br />

between group means. The criterion for statistical<br />

significance was p = 0.05.<br />

Reliability: (3) invalid<br />

Insufficient and partly contradictory documentation. The<br />

experiments were performed in separate sets of exposures, with<br />

separate control groups demonstrating a high variability in<br />

results. Morphometric analyses were performed in only one<br />

dose-group, and the relevance of the subtle changes reported<br />

remains therefore unclear. The findings relating to macrophage<br />

function were not dose related, and appear to be within the<br />

normal physiological ranges. Unacceptable reporting.<br />

21-JUN-<strong>20</strong>04 (133)<br />

Type:<br />

Sub-chronic<br />

Species: rat Sex: male/female<br />

Strain: Fischer 344<br />

Route of administration: oral feed<br />

Exposure period:<br />

13 weeks<br />

Frequency of treatment: continuously<br />

Post exposure period: no<br />

Doses: 0, 0.38, 0.75, 1.5, 3% in diet (corresponding to 0,<br />

222, 441, 886, 1792 mg/kg bw/day in males and to 0,<br />

239, 484, 961, 1975 mg/kg bw/day in females).<br />

Control Group:<br />

yes, concurrent no treatment<br />

NOAEL:<br />

= 886 mg/kg bw<br />

NOAEL, females :<br />

= 1975 mg/kg bw<br />

Method:<br />

GLP:<br />

Test substance:<br />

Result:<br />

other: see Test Condition<br />

no data<br />

other TS: ammonium sulfate, purity not stated<br />

BODY WEIGHTS: at study end final body weights were in males<br />

298, 273, 287, 282 and 284 g for the 0, 0.38, 0.75, 1.5 and<br />

3% groups, respectively. In females, final body weights were<br />

UNEP PUBLICATIONS 175

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