Registration Dossier
Registration Dossier
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EC number: 231-594-1 | CAS number: 7646-93-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read-across conclusions for the following properties under consideration
The basis for the read-across concept for this project is the equilibrium between sulfates, hydrogensulfates, and sulfuric acid in aqueous solutions depending on pH value which is clearly described in published literature and summarised in the following equations:
H2SO4<-> HSO4-+ H+ HSO4-<-> H++ SO42-
As the nature of the cation should make no significant difference in this case concerning toxicity and solubility (all compounds are very soluble in water), only the chemical and biological properties of the anion are considered relevant. Based on the described equilibrium correlations, we propose unrestricted read-across between the groups of sulfates, hydrogensulfates and sulfuric acid concerning systemic toxicity.
The proposed read-across concept only applies to toxicological and ecotoxicological/environmental fate endpoints.
Potassium hydrogensulfate can safely be expected to dissociate under physiological conditions to potassium and sulfate ions, which is why read across to these ions is considered reasonable. Skin sensitisation of sulfuric acid and sodium sulfate is however unlikely, since the human body contains large amounts of sodium, sulfate as well as potassium ions, experience from occupational exposure and human patch testing to sulfuric acid did not elicit any allergic reactions, and experimental testing of sodium sulfate has failed to elicit any skin sensiting reaction.
Furthermore, the test findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, sodium sulfate does not have to be classified as a skin sensitizer.
Based on the read-across concept it can be concluded that potassium hydrogensulfate does not have sensitising properties.
Justification for classification or non-classification
Based on testing of sodium sulfate in an adjuvant sensitisation test (M&K-test) in guinea pigs, and by way of read-across from sodium sulfate and sulfuric acid potassium hydrogensulfate,does not require classification for skin or respiratiory sensitisation.
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