AMMONIUM SULFATE CAS N°: 7783-20-2

OECD SIDS
AMMONIUM SULFATE
3.1.8 Toxicity for Reproduction
There are no valid studies available in which ammonium sulfate has been tested for its effects on
fertility and development. The following are available for the ammonium and the sulfate ion.
Effects on Fertility
In a gavage study performed according to OECD TG 422 with diammonium phosphate (250, 750,
1500 mg/kg) in CD rats (10 females and 5 males/group), no mortality was observed up to the
highest tested dose level of 1500 mg/kg bw/day. Some treatment-related effects on hematology
parameters (reduction in activated partial thromboplastin time for males at 750 or 1500 mg/kg/day
were evident, and bodyweight gain was temporarily reduced in the high dose group (in males week
0 - 5, in females week 1). No treatment-related signs of clinical toxicity were observed. Mating
performance and fertility were unaffected by parental exposure to diammonium phosphate (The
Fertilizer Institute, 2002).
Groups of 10 female ICR mice were given sodium sulfate in drinking water at levels of 0, sodium
control, 625, 1250, 2500 or 5000 mg sulfate/l (ca. 250 - 850, 480 - 2040, 1270 - 4320, 1790 -
6560 mg sulfate/kg bw) beginning one week prior to breeding and up to 14 days during lactation.
At day 21 p.p. the pups were weaned and the dams were rebred at first estrus immediately following
weaning. Only animals that whelped during each parity were used in the analysis. The effective
number of dams per group was low: 4 - 9 in the first parity, and 4 in the second parity. Control
mice, receiving only distilled water, consumed significantly less water than mice receiving sulfate
treatments, and sodium-control mice drank significantly more water than mice treated with sulfate.
No differences were found in litter size, litter weaning weights, or gestational or lactational weight
gain of the dams among sulfate treatments. No toxicity to the dams was found. Litters were not
histopathologically examined. Fertility indices were not measured (Andres and Cline, 1989). The
study is limited in that only females were treated, the number of dams per group was low and no
fertility indices were measured. Moreover the pretreatment period was short.
In a 13-week feeding study of ammonium sulfate with rats, no histological changes of testes were
observed up to 1792 mg/kg bw. The ovaries were not examined (see. chapter 3.1.5; Takagi et al.,
1999).
Developmental Toxicity
In a gavage screening study performed according to OECD TG 422 with diammonium phosphate
(250, 750, 1500 mg/kg bw in rats, animals were paired 2 weeks after start of treatment), no
mortality was observed. Some treatment-related effects on hematology parameters (at 750 and
1500 mg/kg bw) were evident, and bodyweight gain was temporarily reduced in the high dose
group. No treatment-related signs of clinical toxicity were observed. Banding of the enamel of the
incisors of the parent animals from 750 mg/kg bw. was reported, likely due to the inhibiting effect
of phosphate on mineralisation of the teeth. Offspring was unaffected by parental exposure to
diammonium phosphate. Viability up to day 4 pp. and macroscopic necropsy showed no effect on
the pups (The Fertilizer Institute, 2002).
In a screening study, aqueous sodium sulfate was given by gavage to 28 time-pregnant ICR mice at
a dose of 2800 mg/kg bw/day from gestation days 8 through 12. The dose was selected based on
previous range-finding study in non-pregnant mice, 10 % mortality was expected. Mice were
allowed to deliver, and neonates were macroscopically examined, counted, and weighed on day 1
and 3. No evidence of maternal toxicity or increased resorption rate was found. The chemical had
no influence on pup survival, and no adverse developmental effects on external examination were
observed. When compared to controls, birth weight was significantly increased (Seidenberg,
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