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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 287-370-9 | CAS number: 85480-89-3
Endpoint summary
Administrative data
Description of key information
Administration of EDTMP under the conditions of this study (by gavage) resulted in neoplastic (osteosarcomas) and nonneoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance.
The non-neoplastic effects (metaphyseal osteosclerosis) were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
In a well conducted study male and female SD rats were administered EDTMP by gavage, which resulted in neoplastic (osteosarcomas) and non neoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance.
The non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw)
Repeated dose toxicity: via oral route - systemic effects (target organ) other: bone
Justification for classification or non-classification
The data suggest that there is no need to classify for adverse effects following repeated exposures. The NOAEL was derived from a two year oral gavage study in rats, rather than a 90 day study, and the effects reported were not considered to warrant classification.
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.
