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 in vitro skin irritation test showed inconclusive results with regard to skin irritation; however the in vitro skin corrosion test with the structurally related substance EDTA-Cu(NH4)2 was negative. In addition, two studies were available with EDTA-CuNa2 (see also read across document in section 13) on skin irritation, one using a 80% solution, the other study using a 50% solution. The 80% solution showed slight skin irritation but not sufficient for classification, the 50% solution did not show skin irritation.
The in vitro eye irritation test showed borderline irritation in the BCOP (score was 3.1 which is just > 3). No eye irritation was seen in vitro with EDTA-Cu(NH4)2.
Two in vivo studies were also available with EDTA-CuNa2 for eye irritation. The key study with EDTA-CuNa2 showed irritation just sufficient to require classification, the supporting study showed slight irritation not sufficient for classification.
Key value for chemical safety assessment
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Most metal chelates are not irritating to the eyes (see read across document in section 13). However, EDTA-CuK2, like EDTA-CuNa2 showed borderline eye irritation, just requiring classification and labeling. Most metal chelates are neither irritating to the skin; however, EDTA-CuK2 showed inconclusive results in vitro. Based on read across with EDTA-Cu(NH4)2 which was irritating but not corrosive to the skin in vitro, it was concluded that also EDTA-CuK2 was irritating to the skin.
Justification for classification or non-classification
Based on the results of the in vitro skin irritation study and read across with EDTA-CuNa2 and EDTA-Cu(NH4)2, it was concluded that no classification was needed for corrosion but for irritation. For the endpoint skin irritation classification with GHS Cat. 2 should be applied based on the skin irritation observed. Based on the in vitro eye irritation test and the in vivo results with EDTA-CuNa2, classification GHS Cat. 2 is required for eye irritation.
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