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
The oral LD50 value in rats was between 300 and 2000 mg/kg bw; the 4-h LC50 value of the structurally related substance EDTA-CuNa2 is in excess of 5.30 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to EDTA-CuK2 is not expected.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 500 mg/kg bw
- Quality of whole database:
- One study available with EDTA-CuK2 which showed an LD50 value between 300 and 2000 mg/kg bw; ATE is 500 mg/kg bw. Also one study available with EDTA-Cu(NH4)2 and three studies available with EDTA-CuNa2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Studies with other metal chelates show low acute inhalation toxicity (see also section 13 for read across).
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Studies with other metal chelates show low acute dermal toxicity (see also section 13 for read across).
Additional information
The oral LD50 value is between 300 and 2000 mg/kg bw. This was also applicable to EDTA-CuK2. Two earlier acute oral toxicity studies were available with EDTA-CuNa2, one indicating an LD50 value of 890 mg/kg bw, the other indicating an LD50 value of ca. 2100 mg/kg bw. The first study mentioned overnight starvation of the rats, the second study did not mentioning anything on this subject. A RF study prior to the start of an extended OECD 422 study with EDTA-CuNa2, using a single exposure study in non-starved rats showed no mortality at a level of 1500 mg/kg bw. It was therefore concluded that there was a very large difference in acute toxicity between starved and non-starved rats.
Justification for classification or non-classification
EDTA-CuK2 needs to be classified as GHS oral Cat. 4, harmful if swallowed. No classification needed for acute inhalation toxicity as the 4 -h LC50 of the structurally related substance EDTA-CuNa2 is in excess of 5.30 g/m3. No classification needed for acute dermal toxicity.
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