AMMONIUM SULFATE CAS N°: 7783-20-2

OECD SIDS
AMMONIUM SULFATE
5. TOXICITY ID: 7783-20-2
DATE: 18.04.2006
Female pup weight at day 4 (mean): 8.2, 7.9, 8.6, 8.4.
Post-Implantation survival index: 95.2, 93.5, 90.0, 94.8.
Live birth index: 99.3, 99.4, 100.0, 95.9.
Viability index: 98.6, 98.2, 100.0, 100.0.
There were no effects on the time to achieve conception, and
pregnancy length.
Necropsy findings in pups were unremarkable.
Test condition: Animals on the study were distributed to two subgroups
(toxicity and reproductive). The toxicity subgroup consisted
of 5 males and 5 females per group, and these animals
received 5 weeks of continuous daily treatment with
functional observations and bleeds for hematology and blood
chemistry conducted during week 5 of treatment. Organ
weights were recorded at termination during week 6 and
tissues preserved and processed for microscopic examination.
The reproductive subgroup consisted of 10 females and 5
males per group and animals were given continuous daily
treatment until termination. When all the animals had
received two weeks of treatment, the reproductive subgroup
females were paired with the 5 toxicity and the 5
reproductive subgroups males on a one-to-one basis for
assessment of fertility and reproductive function. The
toxicity subgroup males were allowed up to 14 days
cohabitation after which they returned to the toxicity phase
of the study. The females were allowed to litter and rear
their young until day 4 of age when parent females and
litters were subjected to macroscopic necropsy.
All control groups received the vehicle (water purified by
reverse osmosis) alone on the same occasions as the treated
animals.
Reliability: (1) valid without restriction
Flag:
Critical study for SIDS endpoint
12-APR-2006 (151)
Type:
other: sub-chronic
Species:
rat
Sex:
male/female
Strain: Fischer 344
Route of administration: oral feed
Exposure Period:
13 weeks
Frequency of treatment: continuously
Doses: 0, 0.38, 0.75, 1.5, 3% in diet (corresponding to 0,
222, 441, 886, 1792 mg/kg bw/day in males and to 0,
239, 484, 961, 1975 mg/kg bw/day in females).
GLP:
Test substance:
Result:
Test condition:
no data
other TS: ammonium sulfate, purity not stated
Organ weights: no significant changes in absolute and relative
testis weights
Histopathological examinations: no significant pathological
changes were found
TEST ANIMALS/HOUSING: 5 week old SPF F344/DuCri rats from
Charles River Nippon were used and acclimatized for 1 week
prior to the start of the experiments (24 +/- 1 degree C,
relative humidity 55 +/-5%, 18 air exchanges/day, 12 hour
light/dark cycle). Animals were maintained on CRF-1 powder
diet. Rats were randomly divided into five groups, each
group consisting of 10 males and 10 females.
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