Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 270-210-7
CAS number: 68412-79-3
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77996.
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
Testing in bacteria reverse mutation assays,
although of limited relevance for metals (HERAG, 2007), yielded negative
chemical and physiological properties of the pigmentzirconium
iron pink zirconare
inertness because of the specific synthetic process (calcination at high
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:
Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid
within the deep lung under normal health conditions,
phosphate-buffered saline (PBS, pH 7.2), which is a standard
physiological solution that mimics the ionic strength of human blood
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,
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
artificial gastric fluid (GST, pH 1.5), which mimics the very harsh
digestion milieu of high acidity in the stomach.
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.
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.
pH dependent dissolution can be observed.In
conclusion, since the dissolved Zr
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.
reverse mutation assay
bacteria reverse mutation assay (Engelhardt_1992) yielded a negative
result. However, tests on the mutagenic potential of Zirconium
iron pink zircon
in bacteria are considered dispensable for principal considerations,
since inorganic metal compounds are frequently negative in this assay
due to limited capacity for uptake of metal ions (Guidance on
information requirements and chemical safety assessment, Chapter R.7a,
p. 387; HERAG facts sheet mutagenicity, Chapter 2.1). The evaluation of
this reference is therefore primarily based on the method description.
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 genetic toxicity
effects are expected and no further testing is considered to be
required. No classification for genetic toxicity according to EC
Regulation No. 1272/2008 is anticipated.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again