Registration Dossier
Registration Dossier
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EC number: 284-362-7 | CAS number: 84852-49-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No data are available for DTPMP-xK. However, information is available from the related substance, DTPMT acid, from in vitro bacterial and mammalian mutagenicity studies and an in vitro cytogenicity study. Data are available from an in vivo chromosome aberration study in rats on the parent acid, DTPMP-H.
DTPMP-xNa has been tested in a reliable bacterial mutagenicity assay, conducted according to OECD guideline 471 and in compliance with GLP. No increase in the number of revertants was observed in any strain with or without metabolic activation, in either the initial or the repeat assay. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test.
DTPMP-xNa has been tested in a reliable study, conducted according a protocol that is equivalent to OECD guideline 473 and under GLP. A dose related increase in the number of cells with aberrations was observed after 48 hours treatment in an in vitro chromosome aberration assay. It is concluded that the substance is positive for induction of chromosome aberrations in Chinese hamster lung cells under the conditions of the test.
DTPMP-xNa has been tested in a reliable study, conducted according to OECD guideline 476, and in compliance with GLP. No genotoxicity was seen in an in vitro mouse lymphoma L5178Y cell mutagenicity assay in the presence or absence of S9. However, the highest concentration selected for testing was below the maximum required by the guideline.
DTPMP-H has been tested in a reliable study, conducted using a protocol similar to OECD guideline 475, and in compliance with GLP. No evidence of clastogenicity was seen in rat bone marrow following a single oral gavage administration at doses up to the maximum tolerated dose of 1970 mg active acid/kg bw.
The evidence for potential to induce chromosome aberrations in vitro from a study on the sodium salt of DTPMP is not supported by the negative results from an in vivo study on DTPMP acid. Read-across from these other members of the DTPMP category to the registered substance is considered scientifically justified, as there is no reason to consider that a potassium salt will be genotoxic where the sodium salt and the parent acid are not: both potassium and sodium are abundant minerals and play an important role in metabolism.
Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): Read-across from DTPMP-xNa: negative with and without activation in Salmonella typhimurium TA98, TA100, TA 1535, TA 1538 and E. coli WP2 uvrA (OECD TG 471)
Cytogenicity in mammalian cells: Read-across from DTPMP-xNa: positive in Chinese hamster lung IU cells (OECD TG 473)
Mutagenicity in mammalian cells: Read-across from DTPMP-xNa: negative in L5278Y cells (similar to OECD TG 476)
In vivo:
Bone marrow chromosome study in rats (oral gavage administration): Read-across from DTPMP acid: Negative (similar to OECD TG 475)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The in vitro evidence for genetic toxicity is not supported by the in vivo result available.
Based on the available genotoxicity data, DTPMP-xK is not classified for mutagenicity according to Regulation 1272/2008/EC.
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.
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