Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

One chronic study is available with EDTA-CaNa2 in rats, and two supporting chronic studies are available with EDTA-Na3H in rats and mice, respectively.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Because no treatment-related tumours have been observed following chronic exposure to EDTA-CaNa2, and no treatment-related tumours have been observed following chronic exposure to EDTA-Na3H, and EDTA-ZnK2 is expected not to behave differently, EDTA-ZnK2 does not need classification for this endpoint.

Additional information

No treatment-related tumours were observed following chronic exposure to either EDTA-CaNa2 or EDTA-Na3H (see also read across document in section 13). In addition, other chelates did not demonstrate any pre-neoplastic or neoplastic lesions in repeated dose toxicity studies.