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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 269-979-1 | CAS number: 68399-68-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Based on toxicityt findings for the substance to be registered and analogues In-vivo testing not justified.
Data source
Reference
- Title:
- Unnamed
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The approach taken is to consider the chemical structure and class of this substance then estimate the endpoints from both the chemistry, including read-across to similar substance types including potential metabolites.
Literature checks were made on the class of substance and there is a lot of data on alkyl amines and their salts. Derivatives of these have been REACH registered and dossiers disseminated.
Test material
- Reference substance name:
- [[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
- EC Number:
- 244-751-4
- EC Name:
- [[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
- Cas Number:
- 22042-96-2
- Molecular formula:
- C9H28N3O15P5.xNa
- IUPAC Name:
- [[(phosphonomethyl)imino]bis[(ethylenenitrilo)bis(methylene)]]tetrakisphosphonic acid, sodium salt
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: feed
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Type:
- distribution
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Evidence of absorption from examination of blood and bone parameters in a 90 day dietary study
- Details on distribution in tissues:
- Effects in blood and bone suggest distribution
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The substance appears to be absorbed and transported and is not considered accumulative. - Executive summary:
During oral toxicity testing, notably a 90 day dietary study on the penta-phosphonate analogue, there was some evidence of absorption and distribution. There was no suggestion of accumulation, but there is insufficient evidence to indicate whether metabolism or excretion is the main method of elimination.
Evidence of distribution is from effects seen in blood parameters and bone data; these changes were considered to be adaptive, although the 90 day dietary study did not include reversibility.
The S-9 fraction used for in-vitro mutagenicity studies had little impact on cytotoxicity or other findings.
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.
