Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-030-3 | CAS number: 65996-95-4 Substance obtained by acidulating phosphate rock with phosphoric acid. Normally characterized as containing 40% or more available phosphoric oxide (P2O5). Composed primarily of calcium phosphate.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
With triple superphosphate an Ames test and a chromosome aberration study is present. A reliable TK-assay is not available with the substance itself. The assessment of gene mutation in mammalian cells was therefore based on a study conducted with a reference substance as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the read-across approach is provided in the technical dossier (see IUCLID Section 13) and within Chapter 5.1 of the CSR.
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, showing cytotoxicity at the highest concentrations tested. In an in-vitro chromosome aberration test with CHO cells performed according to OECD 473 guideline, also no genotoxicity was seen with and without metabolic activation. 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.
Justification for selection of genetic toxicity endpoint
No study was selected, since all available in-vitro genetic toxicity studies were negative. Hazard assessment is also conducted by means of read-across. The available study with the reference substance is adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Short description of key information:
Based on reliable in-vitro studies with triple superphosphate, the Ames test and the chromosome aberration study were negative in the presence and absence of metabolic activation. No reliable study for the TK assay was present with triple superphosphate, however a reliable in-vitro TK assay 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, triple superphosphate does not have to be classified according to Directive 67/548/EC and the CLP Regulation for genetic toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
