Registration Dossier
Registration Dossier
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EC number: 913-888-8 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
With ammonium dihydrogenorthophosphate no in vitro studies were present for the Ames and the chromosome aberration tests, however with diammonium hydrogenorthophosphate studies are present. However, a reliable TK-assay is available only with ammonium dihydrogenrothophosphate.
In an Ames test according to OECD 471 guideline, Salmonella Typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. Coli WP2 uvr A showed no genotoxicity with and without metabolic activation, tested up to the limit concentration of diammonium hydrogenorthophosphate. In an vitro chromosome aberration test with CHO cells performed according to OECD 473 guideline, also no genotoxicity was seen with and without metabolic activation, while cytotoxicity was present. With ammonium dihydrogenorthophosphate a reliable TK-assay was present. In a Thymidine kinase (TK) assay in L5178Y mouse lymphoma cells performed according to OECD 476 and EC B.17 guidelines, the substance did not induce a significant increase in the mutation frequency. Based on these negative results for genotoxicity in in vitro studies, no in vivo studies are necessary.
Short description of key information:
No reliable Ames and chromosome aberration studies with ammonium dihydrogenorthophoshate are present. Based on reliable in vitro studies with
diammonium hydrogenorthophosphate, the Ames test and the chromosome aberration study were negative in the presence and absence of metabolic activation. For the in vitro TK assay a reliable study with ammonium dihydrogenorthophosphate is present showing negative results in the presence
and absence of metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data, the reaction mass of ammonium dihydrogenorthophosphate and diammonium hydrogenorthophosphate does not have to be classified according to Directive 67/548/EC and the CLP Regulation for genetic toxicity.
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