Registration Dossier
Registration Dossier
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EC number: 237-399-8 | CAS number: 13770-92-8
Endpoint summary
Administrative data
Description of key information
A series of in vitro tests part of a skin sensitizing turnkey testing strategy was performed with the aim of
assessing the skin sensitizing potential of Calcium disulphamate. A combination of the following three in vitro methods, addressing key events of the adverse outcome pathway (AOP) for skin sensitization (OECD, 2012) as defined by the OECD, were part of this in vitro Skin Sensitization Turnkey Testing Strategy:• protein reactivity (DPRA),
• activation of keratinocytes (LuSens), and
• activation of dendritic cells (h-CLAT)
Based on the results summarized in the RSS and applying the evaluation criteria described therein, Calcium disulphamate does not activate keratinocytes and does not activate dendritic cells. The peptide reactivity of the test substance cannot be conclusively evaluated. Applying the evaluation criteria described in the RSS, Calcium disulphamate is predicted not to be a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the findings in an in vitro skin sensitizing turnkey testing strategy, calcium diulphamate does not have to be classified and labeled as a skin sensitizer.
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