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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 />

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

limited documentation, open application, no further<br />

information on purity<br />

Flag:<br />

Critical study for SIDS endpoint<br />

24-AUG-<strong>20</strong>05 (113)<br />

Type:<br />

Species:<br />

Strain:<br />

Sex:<br />

Vehicle:<br />

Doses:<br />

Value:<br />

Method:<br />

GLP:<br />

Test substance:<br />

Remark:<br />

Result:<br />

LD50<br />

mouse<br />

other: ddy<br />

male/female<br />

other: water-acetone solution (no further detail reported)<br />

<strong>20</strong>00 mg/kg bw (limit test)<br />

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

other: see Test Condition<br />

no data<br />

other TS: ammonium sulphate, commercial grade<br />

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

the assessment of the acute dermal 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 > <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 > <strong>20</strong>00 mg/kg bw.<br />

Test condition:<br />

158<br />

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

Male and female ddy mice of 5-6 weeks of age were treated<br />

with the test substance after at least 5 days of adaptation.<br />

Hair was first removed from an area of 1x2 cm2 on the back<br />

with an electric hair clipper, and then the test substances<br />

dissolved in acetone and water were applied in a single dose<br />

to the skin surface of the clipped backs of the animals. The<br />

application sites were not covered but the treated areas<br />

were prevented from being licked by using a plastic collar<br />

or by fixing the animals on a plastic plate, and all animals<br />

were individually housed in stainless-steel cages.<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 mice 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 />

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