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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 />

Species:<br />

Strain:<br />

Sex:<br />

Vehicle:<br />

Doses:<br />

Value:<br />

rat<br />

Wistar<br />

male/female<br />

water<br />

full LD50 test: not reported, -screening test: <strong>20</strong>00 mg/kg bw<br />

(limit test)<br />

> <strong>20</strong>00 mg/kg bw<br />

Method: other: according to TG 423<br />

GLP:<br />

no data<br />

Test substance: other TS: ammonium sulfate, commercial grade<br />

Remark:<br />

Result:<br />

The study was undertaken to validate a screening test for<br />

the assessment of the acute oral toxicity with a view to<br />

minimizing the use of animals in the acute toxicity testing.<br />

Two laboratories cooperated in this study.<br />

Approximative LD50 in males:<br />

in laboratory A > <strong>20</strong>00 mg/kg bw,<br />

in laboratory B ca. <strong>20</strong>00 mg/kg bw<br />

Approximative LD50 in females:<br />

in laboratory A > <strong>20</strong>00 mg/kg bw,<br />

in laboratory B ca. <strong>20</strong>00 mg/kg bw.<br />

Clinical signs, necropsy findings: not reported.<br />

Test condition: The full LD50 test (according to the guidelines of Japan) was<br />

not performed at this study.<br />

For the screening study, male and female Wistar rats of 5-6<br />

weeks of age were treated with the test substance after at<br />

least 5 days of adaptation. The test substance was<br />

administered orally in a single dose after fasting for 16<br />

hours.<br />

Observation of animals, including body weight changes,<br />

mortality, gross lesion and behavioural and clinical<br />

abnormality, were performed for 14 days after exposure, and<br />

necropsy was carried out at the end of the test.<br />

The experiments were performed simultaneously in two<br />

different laboratories.<br />

Three male and three female rats were each given a dose of<br />

<strong>20</strong>00 mg/kg bw. If none of the animals died, further toxicity<br />

tests were not performed and the chemical was regarded as<br />

having an LD50 of greater than <strong>20</strong>00 mg/kg bw. If some of the<br />

animals died, a step 2 test was performed at the level of<br />

<strong>20</strong>0 mg/kg bw. If all animals survived in the step 2 test,<br />

the chemical was considered to have an LD50 greater than <strong>20</strong>0<br />

mg/kg bw. When some of the animals died, the step 3 test<br />

with <strong>20</strong> mg/kg bw was performed. If all the animals died at<br />

this dose level, it meant that he chemical had an LD50 of<br />

less than <strong>20</strong> mg/kg bw. If one or two animals died at the<br />

fixed dose level, the chemical was regarded as having an<br />

LD50 near that dose level, and the approximate LD50 of the<br />

chemical was indicated as ca. <strong>20</strong>, <strong>20</strong>0 or <strong>20</strong>00 mg/kg bw.<br />

Year of study: not reported.<br />

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

limited documentation, no further information on purity<br />

Flag:<br />

Critical study for SIDS endpoint<br />

11-APR-<strong>20</strong>06 (113)<br />

Type:<br />

LD50<br />

UNEP PUBLICATIONS 147

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