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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 />

Exposure period: 24 hours after injection<br />

Doses:<br />

single injection: 0; 62.5; 125; 250; 500 mg/kg; four<br />

injections within 24 h: 31.3; 62.5; 125; 250 mg/kg<br />

Result:<br />

negative<br />

Method:<br />

other<br />

GLP:<br />

no data<br />

Test substance: other TS: Ammonium chloride, purity 99.7%<br />

Remark:<br />

There are no in vivo data on genotoxicity for ammonium<br />

sulfate. To bridge the data gap, data for ammonium chloride,<br />

which dissociates in aqueous media to form ammonium ions, as<br />

does ammonium sulfate, will be used. However, data on sulfate<br />

ions are not available.<br />

Result: MNPCE: single injection: 0.12 %; 4 injections: 0.17 %<br />

Test condition: - The maximum dose of ammonium chloride was determined by<br />

pilot experiments using the multisampling at multi-dose levels<br />

method.Dose up to MTD (maximum tolerated dose) were used.<br />

-Mice were killed 24hr after an administration.<br />

-Femural marrow cells were flushed out with fetal bovine serum<br />

and fixed with methanol and stained with Giemsa.<br />

-One thousand polychromatic erythrocytes per mouse were scored<br />

using a light microscope and the number of micronucleated<br />

erythrocytes (MNPCE) was recorded.<br />

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

Flag:<br />

Critical study for SIDS endpoint<br />

10-APR-<strong>20</strong>06 (146)<br />

5.7 Carcinogenicity<br />

Species: rat Sex: male<br />

Strain:<br />

Fischer 344/DuCrj<br />

Route of administration: gavage<br />

Exposure period:<br />

16 hours<br />

Frequency of treatment: single treatment<br />

Doses:<br />

0, 500, 1000, 1500 or 2660 mg ammonium sulfate/kg bw<br />

(7.56-<strong>20</strong>.1 mM/kg bw) in a volume of 0.5-1 mL by stomach<br />

tube<br />

Control Group:<br />

yes, concurrent no treatment<br />

Method:<br />

other: see Test Condition<br />

Year: 1989<br />

GLP:<br />

no data<br />

Test substance: other TS: ammonium sulfate, reagent grade (Wako Pure<br />

Chemicals, Osaka)<br />

Remark:<br />

Result:<br />

194<br />

These data need careful evaluation as high salt<br />

concentrations were given as a bolus dose directly into<br />

the stomach. It is known that high salt concentrations can<br />

denature proteins leading to cell injury or cell death.<br />

Subsequently cell proliferation might occur as a repair<br />

mechanism causing an increase in ornithine decarboxylase in<br />

the glandular stomach.<br />

The effect of various salts including ammonium sulfate on<br />

ornithine decarboxylase in rat stomach mucosa is<br />

reported.<br />

A 73 fold increase in ornithine decarboxylase activity was<br />

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