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Administrative data

Description of key information

In the performed in vitro tests, the test substance nickel hydrogencitrate did neither have skin irritation nor eye irritation potential.

Key value for chemical safety assessment

Additional information

Two in vitro test were performed in order to assess the irritation potential of nickel hydrogencitrate:

 

Skin

The skin irritation potential of nickel hydrogencitrate was tested according to the draft OECD guideline "In vitro skin irritation: human skin model test", dated December 2007. The administration of 25 mg of the test substance to the human skin model EpiDermTMdid not cause effects, e. g. loss of viability, suggesting irritation potential.

 

Eye

The in vitro HET-CAM test following the ICCVAM test method (dated November 2006) was performed to evaluate the irritation potential of nickel hydrogencitrate. The application of 300 µL of the test substance on the chorioallantoic membrane (CAM) of incubated chicken eggs did not cause effects related to irritation, e. g. haemorrhage, lysis or coagulation, on the CAM.

 

Based on the results of the in vitro studies, it is predicted that the test substance nickel hydrogencitrate is not irritating to the skin and the eye in vivo.

Remark:

Nickel hydrogencitrate and Trinickel dicitrate are comparable: Since citric acid is a multifunctional acid, at different pH values various intermediate ions like citrate, hydrogencitrate and dihydrogencitrate are formed.

Justification for classification or non-classification

Skin

There is conclusive data available which is not sufficient for classification.

Eye

There is conclusive data available which is not sufficient for classification.