Registration Dossier
Registration Dossier
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: 269-075-7 | CAS number: 68187-15-5 An inorganic pigment that is the reaction product of high temperature calcination in which praseodymium (III) oxide, praseodymium (IV) oxide, silicon oxide, and zirconium (IV) oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of zircon. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The in-vitro and in-vivo experiments described above are in very good agreement with regards to the negligible level of bioavailability of the elements Zr and Pr contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, the highest dissolved Zr, Si and Pr concentrations were below 2.4 µg/L (24h, ALF), 62.7 µg/L (24h, ALF) and 574 µg/L (24h, GST), respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.0024 %, 0.063 % and 0.574 %, respectively. Thus, the pigment is considered biologically inert. The dissolved Zr, Pr and Si concentrations from this pigment in GST, after 2h hours (2-hour gastric passage) were below LoD, 350 μg/L and 30 μg/L, respectively, even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Zr and Pr plasma and urine concentrations were observed when sampled at the end of the 28-day exposure period. From a final dose of 1,000 mg/kg of the pigment that the animals received on the last day of the study, only cumulated relative amounts of << 0.001 % (m/f) were found in the terminal 24-h urine collection period.
(3) In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 102% Pr of the dose and 74.3% Zr were excreted via faeces within 3 days, with only <0.00001% Pr and < 0.002% Zr of the dose being excreted via urine at the same time.
(4) In a bioavailability study, the absolute (0.000055% (Pr)) and relative (0.000011% (Pr)) bioavailability of orally administered pigment was calculated in relation to a soluble Pr3+compound (PrCl3), injected i.v..
Comparing the findings ofin-vitrodissolution testing (1) within-vivoresults (2-4), thein-vivodata consistently demonstrates slightly lower bioavailability. This is in agreement with the general understanding thatin-vitroexperiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.
In conclusion, the oral relative bioavailability of the pigment "Zirconium praseodymium yellow zircon" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by anin-vitrodissolution experiment in five different artificial physiological media.
A rounded value of <<0.01% for oral absorption can be taken forward from (i) terminal urine/plasma sampling in a study involving 28 repeated oral doses of 1,000 mg pigment/kg bw/d (<<0.001% for Pr) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.00003% for Pr and <<0.00001% for Zr).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The in-vitro and in-vivo experiments described above are in very good agreement with regards to the negligible level of bioavailability of the elements Zr and Pr contained in the pigment.
(1) In in-vitro dissolution experiments in five different artificial physiological media, the highest dissolved Zr, Si and Pr concentrations were below 2.4 µg/L (24h, ALF), 62.7 µg/L (24h, ALF) and 574 µg/L (24h, GST), respectively, even at the highest loading of 0.1 g/L, referring to a solubility of 0.0024 %, 0.063 % and 0.574 %, respectively. Thus, the pigment is considered biologically inert. The dissolved Zr, Pr and Si concentrations from this pigment in GST, after 2h hours (2-hour gastric passage) were below LoD, 350 μg/L and 30 μg/L, respectively, even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 %.
(2) In a 28-day oral toxicity study with 1,000 mg/kg pigment no increase in Zr and Pr plasma and urine concentrations were observed when sampled at the end of the 28-day exposure period. From a final dose of 1,000 mg/kg of the pigment that the animals received on the last day of the study, only cumulated relative amounts of << 0.001 % (m/f) were found in the terminal 24-h urine collection period.
(3) In a mass balance study with a single oral dose of 1,000 mg/kg of the pigment, 102% Pr of the dose and 74.3% Zr were excreted via faeces within 3 days, with only <0.00001% Pr and < 0.002% Zr of the dose being excreted via urine at the same time.
(4) In a bioavailability study, the absolute (0.000055% (Pr)) and relative (0.000011% (Pr)) bioavailability of orally administered pigment was calculated in relation to a soluble Pr3+compound (PrCl3), injected i.v..
Comparing the findings of in-vitro dissolution testing (1) with in-vivo results (2-4), the in-vivo data consistently demonstrates slightly lower bioavailability. This is in agreement with the general understanding that in-vitro experiments in simulated gastric juice provide a conservative estimate of actual (in-vivo) bioavailability.
In conclusion, the oral relative bioavailability of the pigment "Zirconium praseodymium yellow zircon" can be assumed to be negligible, as demonstrated in three independent in-vivo studies in rats yielding very comparably results supported by an in-vitro dissolution experiment in five different artificial physiological media.
A rounded value of <<0.01% for oral absorption can be taken forward from (i) terminal urine/plasma sampling in a study involving 28 repeated oral doses of 1,000 mg pigment/kg bw/d (<<0.001% for Pr) and (ii) a mass balance study involving a single dose of 1,000 mg pigment/kg bw (0.00003% for Pr and <<0.00001% for Zr).
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.
