Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Endpoint summary

Additional information

Based on the available information on absorption, distribution, metabolism and excretion properties as well as the available toxicological data of all three components of the reaction mass, it can be concluded, that ammonium sulphate is the most critical substance within the reaction mass. Thus, available data on ammonium sulphate will be used for hazard assessment of the toxicological properties of the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate:

 

In vitro Studies

Ammonium sulphate (purity 99.5%) was not mutagenic in bacteria when tested in the standard plate and pre-incubation Ames test performed according to OECD 471 (BASF, 1989). Four bacteria strains of Salmonella typhimurium (TA1535, TA100, TA1537, TA98) were treated with and without a metabolic activation system up to and including 5000 µg/plate. Besides the absence of mutagenicity, no cytotoxic effects were observed.

Ammonium sulphate (food grade) up to 50 mg/mL was also not mutagenic in bacteria strains Salmonella typhimurium TA1535, TA1537 and TA1538 when tested with and without metabolic activation systems (Litton Bionetics Inc., 1975). Again, no cytotoxic effects were observed up to the highest dose tested.

 

The potential of ammonium sulphate to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was investigated in a study according to OECD 476 (BASF, 2010). The assay was performed in two independent experiments, using two parallel cultures. The first experiment was performed with and without liver microsomal activation and a treatment period of 4 h. The second experiment was performed with an exposure time of 4 h with metabolic activation and 24 h without metabolic activation. The highest test concentration of 1320 µg/mL was equal to a molar concentration of about 10 mM. No dose dependent increase of the mutation frequency was observed in both experiments. Thus, ammonium sulphate was found to be not mutagenic in this assay.

 

Chromosome aberration by ammonium sulphate was evaluated in a study similar to OECD 473 (Obe et al., 1986). Human lymphocytes were treated with ca. 423 mg/mL (3.2 M) ammonium sulphate without metabolic activation. While the effects of the restriction endonuclease Alu I on chromosomes were more pronounced when the cells were treated additionally with ammonium sulphate, no increase in chromosomal aberrations was found.

In another chromosome aberration test, treatment of Chinese Hamster Ovary (CHO) cells with ca. 105, 210 and 420 mg/mL (0.8, 1.6 and 3.2 M) ammonium sulphate in the absence of a metabolic activation system did not result in chromosomal aberrations (Tuschy and Obe, 1988). Ammonium sulphate again increased the frequency of chromosome type aberrations, which had been induced by the restriction endonuclease Alu 1. However, such an effect was also observed with other salts (magnesium chloride, calcium chloride and sodium chloride) demonstrating that this effect is not indicative of a direct genotoxic effect of ammonium sulphate but is attributed to the osmolarity of these salts.

Short description of key information:
Based on the read-across data from ammonium sulphate, the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate is considered not mutagenic in vitro.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on read-across, the available data on genetic toxicity are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).