Registration Dossier
Registration Dossier
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EC number: 913-747-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Ames test / Sulfuric acid (read-across with Sodium hydrogensulphate monohydrate):
The mutagenicity of sodium hydrogensulphate monohydrate was investigated in an Ames test (plate incorporation method) using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. Quadruplicate cultures of each strain were exposed for 48 hours to the test material (dissolved in demineralised water) in the absence and presence of an exogenous metabolic acitvation system (Aroclor 1254 -induced male Sprague-Dawley rat S9 fraction) at concentrations of 0 (solvent control), 20, 100, 500, 2500 and 12500 ug/plate.
Evidence of cytotoxicity (reduced numbers of revertant colonies) was seen at the highest concentration in the absence of S9 and at 2500 and 12500 ug/plate in the presence of S9. Exposure to the test material did not induce any increase in the numbers of revertant colonies of any strain. Appropriate positve control compounds (sodium azide, nitrofurantoi, 4 -nitrophenylenediamine and 2 -aminoanthracene) produced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. No evidence of mutagenicity was seen under the conditions of this assay.
Ames test / Sulfuric acid (read-across with sodium sulphate):
The mutagenicity of sodium sulphate was investigated in an Ames test (plate incorporation method) using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. Quadruplicate cultures of each strain were exposed for 48 hours to the test material (dissolved in demineralised water) in the absence and presence of an exogenous metabolic activation system (Aroclor 1254 -induced male Sprague-Dawley rat S9 fraction) at concentrations of 0 (solvent control), 8, 40, 200, 1000 and 5000 ug/plate.
No evidence of cytotoxicity was seen at the highest (limit) concentration in the absence or presence of S9. Exposure to the test material did not induce any increase in the numbers of revertant colonies of any strain. Appropriate positive control compounds (sodium azide, nitrofurantoi, 4 -nitrophenylenediamine and 2 -aminoanthracene) produced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. No evidence of mutagenicity was seen under the conditions of this assay.
Ames test / Nitrate ions (read-across with sodium nitrate):
Short description of key information:
Nitrosylsulfuric is not mutagenic in the in vitro studies (Ames test).
In water, nitrosylsulfuric acid (HNO5S) decomposes at ambient temperature into sulfuric acid (H2O4S) and nitrous acid (HNO2).
Nitrous acid is also not stable in water at ambient temperature and decomposes into nitric oxide (NO) and nitrate ion (NO3-).
That is the reason why the assessment of the toxicity of nitrosylsulfuric acid is based on the toxicological properties of its breakdown products in water: sulfuric acid and nitrate ions.
Besides, to assess the genotoxicity of nitrosylsulfuric acid, the toxicities of sulfuric acid and nitrate ions assessed in previous studies will be used.
Two key studies (Ames test) are available for sulfuric acid (read across with sodium sulphate and Sodium hydrogensulphate monohydrate) : results are negative.
A Ames test is available for nitrate ion (read across with sodium nitrate) : result is negative.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to EU regulation (EC) No 1272/2008 (CLP) andto EU Directive 67/584/EEC, Nitrosylsulphuric acid is not classified for mutagenicity endpoint.
Justification : Results oftests with sodium hydrogensulphate monohydrate and with sodium sulphate are negative, and we can conclude that sulfuric acid is not mutagen by read-across.
Results of Ames test with sodium nitrate are negative, we can conclude that nitrate is not mutagenic.
Finally, Nitrosylsulphuric acid is considered as not mutagenic according to the negative results of Ames Test on sulfuric acid and nitrate.
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