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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-238-2 | CAS number: 1314-61-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Available data on tantalum pentoxide (target substance) indicate a lack of mutagenicity in all available in vitro assays (OECD 471, OECD 473). Additionally data on tantalum pentachloride point to a lack of mutagenicity in in vitro assays according to OECD 476 used in a read-across approach for the assessment of tantalum pentoxide.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The data available for ditantalum pentaoxide (target substance) does not fulfil all requirements of REACH Annex VIII. Thus, data from tantalum pentachloride were used in a read-across approach. ditantalum pentaoxide was tested negative in a bacterial reverse mutation test (OECD 471; May 2001) and an in vitro chromosome aberration test (OECD 473; Hargitai 2013). Tantalum pentachloride was tested negative in an in vitro HPRT study (OECD 476),
Due to lower transformation/dissolution results for ditantalum pentaoxide than for tantalum pentachloride the resulting toxicity potential would also be expected to be lower. Therefore, the read across to the source substance Tantalum pentachloride is adequately protective. For more details refer to the read-across report attached to IUCLID section 13.
As negative data is available for the higher tier mammalian mutagenicity tests (OECD 473 and OECD 476 with Tantalum pentachloride), ditantalum pentoxide is considered to be non-mutagenic.
Justification for selection of genetic toxicity endpoint
GLP guideline study.
Supporting information
In a literature paper by Keçeli & Alanyali (2004), the cytotoxicity of several metal oxides was examined.
Kidney fibroblast cells from an African Green Monkey were used in the in vitro study. The cells were incubated, in the presence of Tantalum oxide coated glass platelets, for 7 days. The cells where then examined for differences in cell morphology and proliferation. The morphology did not change, although a lower rate of proliferation was seen compared to the control. It was not possible to determine if the test material is toxic to cells.
Justification for classification or non-classification
No genotoxic effects were observed in OECD guideline tests with Ditantalum pentoxide and Tantalum pentachloride. Based on the available data from the read-across partner and itself, Tantalum pentoxide does not warrant classification for mutagenicity.
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.
