Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

The chemical and physiological properties of the pigmentzirconium iron pink zirconare characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This manufacturing process leads to a very low bioaccessibility of the elements contained in the pigment. This has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral, dermal and inhalation), as follows:

1.) Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,

2.) phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,

3.) artificial sweat (ASW, pH 6.5) which simulates the hypoosmolar fluid, linked to hyponatraemia (loss of Na+ from blood), which is excreted from the body upon sweating,

4.) artificial lysosomal fluid (ALF, pH 4.5), which simulates intracellular conditions in lung cells occurring in conjunction with phagocytosis and represents relatively harsh conditions and

5.) artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.

 

The dissolution of Zr of the test item is between below LoD (0.22 µg/LL (PBS) and 67.1 µg/L/ 64.2 µg/L (GST) at a loading of 0.1g/L after 2 and 24 hours.

The dissolution of Fe of the test item is in a range of below LoD (1.78 µg/L)/ below LoQ (5.95 µg/L,GMB) and 16.5 µg/L/ 25.4 µg/L (GST) at a loading of 0.1g/L after 2 and 24 hours.

A pHdependent dissolution can be observed.In conclusion, since the dissolvedZr and Fe concentrations were below 65 µg/L even at the highest loading of 0.1g/L, referring to a solubility of 0.065 %, this pigment may reasonably be considered biologically inert.


Short description of key information:
In conclusion, since the dissolved Zr and Fe concentrations from this pigment (zirconium iron pink zircon) under simulated physiological conditions were below 67.1 µg/L and 25.4 µg/L respectively, even at the highest loading of 0.1g/L, referring to a solubility of 0.07 % and 0.03 %, the pigment is considered biologically inert.

Effects on developmental toxicity

Description of key information
In conclusion, since the dissolved Zr and Fe concentrations from this pigment (zirconium iron pink zircon) under simulated physiological conditions were below 67.1 µg/L and 25.4 µg/L respectively, even at the highest loading of 0.1g/L, referring to a solubility of 0.07 % and 0.03 %, the pigment is considered biologically inert.
Additional information

The chemical and physiological properties of the pigmentzirconium iron pink zirconare characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This manufacturing process leads to a very low bioaccessibility of the elements contained in the pigment. This has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral, dermal and inhalation), as follows:

1.) Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,

2.) phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,

3.) artificial sweat (ASW, pH 6.5) which simulates the hypoosmolar fluid, linked to hyponatraemia (loss of Na+ from blood), which is excreted from the body upon sweating,

4.) artificial lysosomal fluid (ALF, pH 4.5), which simulates intracellular conditions in lung cells occurring in conjunction with phagocytosis and represents relatively harsh conditions and

5.) artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.

 

The dissolution of Zr of the test item is between below LoD (0.22 µg/LL (PBS) and 67.1 µg/L/ 64.2 µg/L (GST) at a loading of 0.1g/L after 2 and 24 hours.

The dissolution of Fe of the test item is in a range of below LoD (1.78 µg/L)/ below LoQ (5.95 µg/L,GMB) and 16.5 µg/L/ 25.4 µg/L (GST) at a loading of 0.1g/L after 2 and 24 hours.

A pHdependent dissolution can be observed.In conclusion, since the dissolvedZr and Fe concentrations were below 65 µg/L even at the highest loading of 0.1g/L, referring to a solubility of 0.065 %, this pigment may reasonably be considered biologically inert.

Justification for classification or non-classification

The chemical and physiological properties of the pigment zirconium iron pink zircon are characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. Bioavailability which is the basis for the oral, dermal or inhalation exposure route is not given.In consequence, this substance may reasonably be considered inert in all media relevant for uptake into the body and also the compartment relevant for distribute within body tissues. Hence, no toxicity to reproduction, effects on fertility and developmental toxicity effects are expected and no further testing is considered to be required. No classification for toxicity to reproduction according to Directive 67/548/EEC and EC Regulation No. 1272/2008 is anticipated.