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REACH

[No public or meaningful name is available]

EC number: - | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Acute Toxicity: dermal

Administrative data

Endpoint:: acute toxicity: dermal
Data waiving:: study scientifically not necessary / other information available
Justification for data waiving:: the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Cross-reference

Reason / purpose for cross-reference:: data waiving: supporting information

Reference

Endpoint:: basic toxicokinetics, other
Remarks:: transformation/dissolution in artificial physiological media
Type of information:: experimental study
Adequacy of study:: key study
Study period:: 2017-08-25 - 2017-11-07
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: comparable to guideline study
Objective of study:: bioaccessibility (or bioavailability)
Qualifier:: equivalent or similar to guideline
Guideline:: OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
Deviations:: yes
Remarks:: Bioaccessibility testing: loading of 100 mg/L; five artificial physiological media agitated at 100 rpm, at 37 °C ± 2 °C; sampling after 2 h and 24 h; determination of Cr,Fe, Ti and Zn concentrations after filtration by ICP-OES.
Principles of method if other than guideline:: The test was performed on the basis of OECD Series on Testing and Assessment No. 29 as well as according to the bioaccessibility test protocol that has been developed on the basis of relevant published methods ([1], [2], [3], [4] and [5]).

The aim of this test was to assess the dissolution of the pigment IIPC-2018-011 (Chromium, iron, titanium and zinc spinel and rutile) in the artificial physiological media GST, GMB, ALF, ASW and PBS. The test media were selected to simulate relevant human-chemical interactions (as far as practical), i.e. a substance entering the human body by ingestion or by inhalation.

Five different artificial physiological media with a single loading of test substance of 100 mg/Lwere used. The measurement of dissolved iron and magnesium concentrations after filtration were performed by ICP-OES. Samples were taken after 2 and 24 hours agitation (100 rpm) at 37 ± 2 °C. The study was performed in triplicate with two additional method blanks per medium.

[1] Hanawa T. 2004. Metal ion release from metal implants. Materials Science and Engineering C 24: 745-752.
[2] Stopford W., Turner J., Cappelini D., Brock T. 2004. Bioaccessibility testing of cobalt compounds. Journal of Environmental Monitoring 5: 675-680.
[3] Midander K., et al. 2007. In vitro studies of copper release from powder particles in synthetic biological media. Environmental Pollution 145: 51-59.
[4] European standard 1998. Test method for release of nickel from products intended to come into direct and prolonged contact with the skin (EN 1811)
[5] ASTM 2003. Standard test method for determining extractability of metals from art materials. ASTM D5517-03.
GLP compliance:: yes (incl. QA statement)
Species:: other: in vitro (simulated human body fluids)
Details on test animals or test system and environmental conditions:: Test principle in brief:
- five different artificial physiological media,
- single loading of test substance of 100 mg/L,
- samples taken after 2 and 24 hours agitation (100 rpm) at 37 ± 2 °C,
- two method blanks per artificial media were tested; measurement (by ICP-OES) of dissolved chromium, iron, titanium and zinc after filtration
- the study was performed in triplicate

The aim of this test was to assess the dissolution of IPC-2018-011 (Chromium, iron, titanium and zinc spinel and rutile) in five artificial physiological media: Artificial lysosomal fluid (ALF, pH = 4.5), Artificial sweat solution (ASW, pH = 6.5), Gamble´s solution (GMB, pH = 7.4), Artificial gastric fluid (GST, pH = 1.5), Phosphate buffered saline (PBS, pH = 7.4). The test media were selected to simulate relevant human-chemical interactions (as far as practical), i.e. a substance entering the human body by ingestion into the gastrointestinal tract and by inhalation.
Duration and frequency of treatment / exposure:: Samples were taken after 2 h and 24 h.
Dose / conc.:: 100 other: mg of the test item /L artificial media
Details on study design:: Reagents
The water (resistivity >18 MΩ·cm.) used for this test was purified with a Pure Lab Ultra water purification system from ELGA LabWater, Celle, Germany.
- Nitric acid - “Supra” quality (ROTIPURAN® supplied by Roth, Karlsruhe, Germany).
- Hydrochloric acid – “instra-analyzed plus” quality (J.T. Baker, Griesheim, Germany).
- Sodiumhydroxide – pro Analysis quality (Chemsolute, Th. Geyer, Renningen, Germany)

Metal analysis
- Standards:
- Certified reference materials: As quality control standards certified aqueous reference material TM-26.4 (lot no. 1115) and TMDA-52.4 (lot no. 0915) obtained from Environment Canada and a multielement standard (Roth Multielemenstandard, lot no. F38770, Karlsruhe, Germany) were analysed for total dissolved chromium, iron, titanium and zinc by ICP-OES along with the samples to determine the accuracy of the applied analytical method. Furthermore, the calibration solutions were measured along with the ICP-OES measurements as recalibration standards.

Instrumental and analytical set-up for the ICP-OES instrument:
Agilent 720, Agilent Technologies, Waldbronn, Germany
Nebulizer: Sea spray nebulizer from Agilent
Spray chamber: Glass cyclonic spray chamber from Agilent
Plasma stabilization time: at least 30 min before start of the measurements
Plasma gas flow: 15.0 L/min
Additional gas flow: 1.50 L/min
Carrier gas flow: 0.75 L/min
RF power: 1200W
Stabilization time of sample: 15 sec
Repetition time (three internal measurements per sample): 30 sec

Wavelengths: Cr: 206.158 nm, 267.716 nm and 276.653 nm
Fe: 238.204 nm, 241.052 nm and 259.837 nm
Ti: 337.280 nm, 368.520 nm and 376.132 nm
Zn: 202.548 nm, 206.200 nm and 213.857 nm

Data treatment, LOD/LOQ calculations
The applied LOD/LOQ calculations for the Agilent 720 ICP-OES are (according to DIN 32645):
LOD: 3 x standard deviation of calibration blank/slope of the calibration
LOQ: 3 x LOD
All Cr, Ti, Zn and Fe concentrations were corrected for background elemental concentrations as
determined by the means of the corresponding blank vessels.

Calibration: blank, 1 µg/L, 2 µg/l, 4 µg/L, 6 µg/L, 8 µg/L, 10 µg/L, 20 µg/L, 40 µg/L, 60 µg/L, 80 µg/L, 100 µg/L, 120 µg/L, 140 µg/L, 150 µg/L, 160 µg/L, 180 µg/L, 200 µg/L, 250 µg/L, 300 µg/L, 350 µg/L, 400 µg/L, 450 µg/L and 500 µg/L, for measurements of test vessel samples and for mass balance sample calibration was extended to 750 µg/L and 1000 µg/L.
Correlation coefficients (r): at least 0.998661
Details on dosing and sampling:: Loading:
The nominal loading in this test was 100 mg/L. However, due to weighing uncertainties the actual loadings range from 100.004 mg/L to 100.028 mg/L in the 15 test vessels.
Type:: other: Bioaccessibility
Results:: Higest dissolution at a loading of 0.1g/L in GST after 24h: Cr = 20.9µg/L, Fe = 90.2µg/L, Ti = 94.6µg/L, Zn = 112µg/L
Bioaccessibility (or Bioavailability) testing results:: Concentration of dissolved chromium in artificial physiological media (total Cr ± SD).
GST 2h: 10.3 ± 0.74 µg/L
GST 24h: 20.9 ± 0.29 µg/L
GMB 2h: 2.98 ± 0.03 µg/L
GMB 24h: 3.43 ± 0.13 µg/L
ALF 2h: 8.52 ± 0.51 µg/L
ALF 24h: 16.4 ± 0.10 µg/L
ASW 2h: 4.02 ± 0.09 µg/L
ASW 24h: 6.10 ± 0.17 µg/L
PBS 2h: 3.21 ± 0.18 µg/L
PBS 24h: 4.32 ± 0.18 µg/L

Concentration of dissolved iron in artificial physiological media (total Fe ± SD).
GST 2h: 25.2 ± 3.60 µg/L
GST 24h: 90.2 ± 1.71 µg/L
GMB 2h: 0.660 µg/L
GMB 24h: < LOD
ALF 2h: 20.0 ± 0.82 µg/L
ALF 24h: 47.9 ± 0.87 µg/L
ASW 2h: < LOD
ASW 24h: 1.46 ± 1.16 µg/L
PBS 2h: 2.00 ± 2.25 µg/L
PBS 24h: < LOD

Concentration of dissolved titanium in artificial physiological media (total Ti ± SD).
GST 2h: 25.7 ± 3.72 µg/L
GST 24h: 94.6 ± 1.76 µg/L
GMB 2h: < LOD/LOQ
GMB 24h: 0.830 ± 0.236 µg/L
ALF 2h: 18.0 ± 0.77 µg/L
ALF 24h: 46.1 ± 0.13 µg/L
ASW 2h: 1.30 ± 0.43 µg/L
ASW 24h: 19.7 ± 0.51 µg/L
PBS 2h: < LOD
PBS 24h: 1.71 ± 0.11 µg/L

Concentration of dissolved zinc in artificial physiological media (total Zn ± SD).
GST 2h: 86.9 µg/L
GST 24h: 112 µg/L
GMB 2h: 0.688 µg/L
GMB 24h: ALF 2h: 78.2 µg/L
ALF 24h: 101 µg/L
ASW 2h: 17.0 µg/L
ASW 24h: 63.0 µg/L
PBS 2h: 4.24 ± 2.04 µg/L
PBS 24h: 38.2 ± 0.84 µg/L
Conclusions:: On the basis of OECD Series on Testing and Assessment No. 29 as well as according to a bioaccessibility test protocol, which has been developed on the basis of relevant published methods, the dissolution of the pigment IPC-2018-011 (chromium, iron, titanium and zinc spinel and rutile) in the artificial physiological media (GST, GMB, ALF, ASW and PBS) with a single loading of 100 mg/L, agitation (100 rpm) at 37 °C ± 2 °C and sampling after 2 and 24 h, was determined. The measurement of dissolved chromium, iron, titanium and zinc concentrations after filtration were performed by ICP-OES. The study was performed in triplicate with two additional method blanks per medium.

Concentration of dissolved chromium in artificial physiological media (total Cr ± SD).
GST 2h: 10.3 ± 0.74 µg/L
GST 24h: 20.9 ± 0.29 µg/L
GMB 2h: 2.98 ± 0.03 µg/L
GMB 24h: 3.43 ± 0.13 µg/L
ALF 2h: 8.52 ± 0.51 µg/L
ALF 24h: 16.4 ± 0.10 µg/L
ASW 2h: 4.02 ± 0.09 µg/L
ASW 24h: 6.10 ± 0.17 µg/L
PBS 2h: 3.21 ± 0.18 µg/L
PBS 24h: 4.32 ± 0.18 µg/L

Concentration of dissolved iron in artificial physiological media (total Fe ± SD).
GST 2h: 25.2 ± 3.60 µg/L
GST 24h: 90.2 ± 1.71 µg/L
GMB 2h: 0.660 µg/L
GMB 24h: < LOD
ALF 2h: 20.0 ± 0.82 µg/L
ALF 24h: 47.9 ± 0.87 µg/L
ASW 2h: < LOD
ASW 24h: 1.46 ± 1.16 µg/L
PBS 2h: 2.00 ± 2.25 µg/L
PBS 24h: < LOD

Concentration of dissolved titanium in artificial physiological media (total Ti ± SD).
GST 2h: 25.7 ± 3.72 µg/L
GST 24h: 94.6 ± 1.76 µg/L
GMB 2h: < LOD/LOQ
GMB 24h: 0.830 ± 0.236 µg/L
ALF 2h: 18.0 ± 0.77 µg/L
ALF 24h: 46.1 ± 0.13 µg/L
ASW 2h: 1.30 ± 0.43 µg/L
ASW 24h: 19.7 ± 0.51 µg/L
PBS 2h: < LOD
PBS 24h: 1.71 ± 0.11 µg/L

Concentration of dissolved zinc in artificial physiological media (total Zn ± SD).
GST 2h: 86.9 µg/L
GST 24h: 112 µg/L
GMB 2h: 0.688 µg/L
GMB 24h: ALF 2h: 78.2 µg/L
ALF 24h: 101 µg/L
ASW 2h: 17.0 µg/L
ASW 24h: 63.0 µg/L
PBS 2h: 4.24 ± 2.04 µg/L
PBS 24h: 38.2 ± 0.84 µg/L

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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