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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Two in vitro studies were available. The in vitro skin irritation test showed skin irritation, the in vitro skin corrosion test 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.

One in vitro study was available for eye irritation; no eye irritation was observed. Two 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

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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). Most metal chelates are neither irritating to the skin, but in this case EDTA-Cu(NH4)2 was irritating but not corrosive to the skin in vitro.


 

Justification for classification or non-classification

Based on the results of the in vitro skin irritation and the in vitro skin corrosion studies 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. No classification is required for eye irritation.