Registration Dossier
Registration Dossier
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EC number: 237-865-0 | CAS number: 14025-21-9
Endpoint summary
Administrative data
Description of key information
The acute oral LD50 value in rats was > 2000 mg/kg bw. Although an acute inhalation with this substance was not performed, inhalation studies with other metal chelates showed that these substances are not toxic (4-h LC50 value > 5 mg/L or at the maximally attanaible concentration). In addition, acute dermal toxicity studies with other metal chelates showed that LD50 values were in excess of 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The key study was conducted according to GLP and guidelines. Sufficient data is available also for the other metal-chelates (see also read across document in section 13) for the interpretation of study results.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Other studies with metal-chelates of EDTA (EDTA-MnNa2, EDTA-FeNa, EDTA-CuNa2) showed very limited acute toxicity (4-h LC50 > 5 mg/L). In addition, a study with Ca-DTPA showed a 2-h LC50 > 1.15 mg/L. See also read across document in section 13.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Other studies with metal-chelates of EDTA (EDTA-Fe(NH4)2OH, EDTA-FeNa) showed very limited acute toxicity (LD50 > 2000 mg/kg bw). See also read across document in section 13.
Additional information
The oral and inhalation route for the endpoint acute toxicity are covered. A third route is not reqired by Regulation 1907/2006. In addition, the absorption via the skin is expected to be very low (EU RAR, 2004).
Justification for classification or non-classification
Based on the very low toxicity of EDTA-ZnNa2 via the oral route, and the expected very low toxicity via the inhalation route and taking into account the very low dermal absorption of EDTA-compounds, no classification is needed for acute toxicity.
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