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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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 no reliable study is present for the substance. Such a study performed with ammonium dihydrogenorthophosphate showed negative results in the presence and absence of metabolic activation. The read-across rationale can be found in the category approach document attached in IUCLID Section 13 and fully included in the CSR (Appendix A).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

With diammonium hydrogenorthophosphate in vitro studies were present for the Ames and the chromosome aberration tests. No reliable TK-assay with this substance itself was present, however with ammonium dihydrogenorthophosphate a study is present.

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. 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. In a Thymidine kinase (TK) assay in L5178Y mouse lymphoma cells performed according to OECD 476 and EC B.17 guidelines, ammonium dihydrogenorthophosphate 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
An Ames test and a chromosome aberration study with the substance are available, showing no adverse effects. A reliable Mouse lymphoma study with the read-across substance ammonium dihydrogenorthophosphate is available, showing no adverse effects.


Justification for classification or non-classification

Based on the available data, diammoniumhydrogenorthophosphate does not have to be classified according to Directive 67/548/EC and the CLP Regulation for genetic toxicity.