AMMONIUM SULFATE CAS N°: 7783-20-2

OECD SIDS
AMMONIUM SULFATE
diarrhoea during the administration period. According to the authors the NOAEL (male) was
886 mg/kg bw/day and the NOAEL (female) was 1975 mg/kg bw/day (Takagi et al., 1999). The
main limitation of the study is the low number of organs examined histopathologically compared to
a standard 13-week guideline study.
Studies in Humans
There were no studies in humans available.
Conclusion
A 14-day inhalation study on rats exposed to 300 mg/m 3 , the only tested dose, did not report
histopathological changes in the lower respiratory tract. As the respiratory tract is the target organ
for inhalation exposure, the NOEL for toxicity to the lower respiratory tract is 300 mg/m 3 .
The NOAEL after feeding diets containing ammonium sulfate for 13 weeks to rats was 886 mg/kg
bw/day. The only toxicity sign found was diarrhea in male animals of the high-dose group
(LOAEL: 1792 mg/kg bw/day).
3.1.6 Mutagenicity
Studies in Animals
In vitro Studies
Ammonium sulfate was not mutagenic in the standard plate and pre-incubation Ames test
performed in 4 strains of Salmonella typhimurium (TA1535, TA100, TA1537, TA98) with and
without a metabolic activation system up to and including the maximum tested concentration of
5000 µg/plate. No cytotoxic effects were observed (BASF AG, 1989b). Ammonium sulfate was
also not mutagenic in Salmonella typhimurium strains TA1535, TA1537 and TA1538, and in
Saccharomyces cerevisiae D4 with and without metabolic activation systems. Again, no cytotoxic
effects were observed up to the highest tested concentration of 50 000 ppm (Litton Bionetics, 1975).
Treatment of Chinese Hamster Ovary (CHO) (Tuschy and Obe, 1988) cells and treatment of human
lymphocytes (Obe, Jonas and Schmidt, 1986) with 3.2 M (423 mg/ml) ammonium sulfate in the
absence of a metabolic activation system, did not result in chromosomal aberrations. However,
ammonium sulfate enhanced the frequency of chromosome type aberrations, which had been
induced by the restriction endonuclease Alu 1. A similar effect was observed with other salts
(magnesium chloride, calcium chloride and sodium chloride), and is not indicative of a mutagenic
effect of ammonium sulfate (Obe, Jonas and Schmidt, 1986; Tuschy and Obe, 1988).
In vivo Studies
The dossier of ammonium chloride reported negative results in a micronucleus test in mice (SIAM
16, 2003). This micronucleus test was conducted with bone marrow in ddY mice (Hayashi et al.,
1988). Animals had received a single and 4 times i.p. injection. A single dose test and 4 times dose
test were dosed with 62.5 - 500 mg/kg and 31.3 - 250 mg/kg as MTD (maximum tolerated dose),
respectively, with mitomycin C as positive control. No increase of erythrocytes with micronuclei
was observed at any group.
The potential of ammonium sulfate to induce mutagenic effects in vivo is considered to be
negligible, because there is no evidence of a mutagenic effect from in vitro studies. There are no in
vivo studies available with ammonium sulfate.
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