AMMONIUM SULFATE CAS NÂ°: 7783-20-2

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OECD SIDS AMMONIUM SULFATE Studies in Humans There is no data available. Conclusion Ammonium sulfate was not mutagenic in bacteria (Ames test) and yeasts with and without metabolic activation systems. It did not induce chromosomal aberrations in mammalian or human cell cultures. No in vivo genotoxicity tests are available. Based on the negative results from in vitro studies and the negative results in the micronucleus test in vivo with ammonium chloride a mutagenic activity of ammonium sulfate in vivo is unlikely. 3.1.7 Carcinogenicity In vitro Studies There is no data available. In vivo Studies in Animals Inhalation There is no data available. Dermal There is no data available. Oral The effect of various salts including ammonium sulfate on ornithine decarboxylase (ODC) as a marker for tumor promotion in rat stomach mucosa was reported by Furihata et al. (1989). A 73 fold increase in enzyme activity was measured with a maximum at 16 hours after a single oral gavage (500 - 2660 mg/kg bw). In comparison, an equimolar dose of NaCl (25.7 mmol = 1500 mg/kg bw) induced a 248 fold increase in enzyme activity. The authors concluded that the various tested salts may have the capability of tumor promotion in the glandular stomach of rats. In this study, very high salt concentrations were given in a bolus directly into the stomach. High salt concentrations can denature proteins resulting in cell injury or cell death with subsequent cell proliferation as a repair mechanisms causing the increase in ODC activity which is a normal, secondary physiological response to cellular injury and death. Therefore, the study did not provide supporting evidence for carcinogenicity of ammonium sulfate. Studies in Humans Respiratory Tract In a nested case-control study within the active workforce of a large chemical manufacturing firm over a 23-year period, no association with Hodgkin`s disease was identified for 11 chemicals (including ammonium sulfate) (Swaen et al., 1996). Conclusion Similarly to other salts, high doses of ammonium sulfate may have the capability of tumor promotion in the rat stomach; it is, however, much less potent than sodium chloride when tested under identical conditions. 24 UNEP PUBLICATIONS
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, UNEP PUBLICATIONS 25
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AMMONIUM SULFATE CAS NÂ°: 7783-20-2

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