Registration Dossier
Registration Dossier
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EC number: 277-749-7 | CAS number: 74181-84-3
Endpoint summary
Administrative data
Description of key information
One well performed and reported subchronic oral toxicity study was available for EDTA-CuNa2. See the read across document in section 13 for studies with other (metal) chelates.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 150 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Well performed and reported GLP study with EDTA-CuNa2
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
When comparing the results of the study with EDTA-CuNa2 with repeated dose studies of other metal chelates (see read across document in section 13), it was concluded that EDTA-CuNa2 was slightly more toxic (LOAEL of 150 mg/kg bw) than the other metal chelates (NOAELs >= 500 mg/kg bw). In addition, it was also concluded, based on the limited effects observed at 150 mg/kg bw, the NOAEL would be close to 150 mg/kg bw. The same is expected for EDTA-CuK2.
Justification for classification or non-classification
Because in the subchronic study with EDTA-CuNa2, effects were limited at a dose level of 150 mg/kg bw, no classification is needed for STOT repeated exposure.
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