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EC number: 235-759-9 | CAS number: 12656-85-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed in accordance with the recommended Standard Operating Procedure (SOP) for the Bio-accessibility Testing Programme of Eurometaux (November 10, 2010), and under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
- Objective of study:
- other: Bio-elution
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Operating Procedure (SOP) for the Bio-accessibility Testing Programme of Eurometaux (November 10, 2010), based on ASTM D5517-07: standard test method for determining the extractability of metals from art materials - ASTM, 2007
- Deviations:
- no
- Principles of method if other than guideline:
- Bio-elution of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 were studies in simulated body fluids: gastric, interstitial, intracellular and perspiration fluid, to determine bioavailability of chrome and lead for absorption.
- GLP compliance:
- yes
Test material
- Reference substance name:
- C.I. Pigment Yellow 34
- IUPAC Name:
- C.I. Pigment Yellow 34
- Reference substance name:
- Lead sulfochromate yellow
- EC Number:
- 215-693-7
- EC Name:
- Lead sulfochromate yellow
- Cas Number:
- 1344-37-2
- IUPAC Name:
- 1344-37-2
- Reference substance name:
- Lead chromate molybdate sulfate red
- EC Number:
- 235-759-9
- EC Name:
- Lead chromate molybdate sulfate red
- Cas Number:
- 12656-85-8
- Molecular formula:
- Pb (Cr,S,Mo) O4
- IUPAC Name:
- tris(λ²-lead(2+)) dioxochromiumbis(olate) dioxomolybdenumbis(olate) sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):
C.I. Pigment Yellow 34 (DCC Yellow 1007)
C.I. Pigment Red 104 (DCC Orange 1629)
- Molecular formula:
C.I. Pigment Yellow 34: lead sulfo chromate yellow (main constituent), Pb(Cr,S)O4
C.I. Pigment Red 104: lead chromate molybdate sulfate red (main constituent) Pb(Cr,S,Mo)O4
- Molecular weight (if other than submission substance):
C.I. Pigment Yellow 34: 355
C.I. Pigment Red 104: 452
- Physical state: solid
- Lot/batch No.: confidential information
- Stability under test conditions: Stable over time
- Storage condition of test material: Room temperature, in the dark
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- no
Test animals
- Species:
- other: not applicable, in vitro studies
- Details on test animals or test system and environmental conditions:
- Not applicable
Administration / exposure
- Route of administration:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Gastric fluid: 2 hours
Interstitial, intercellular and perspiration fluid: 24h and 168h (7 days)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Loading rate:
Gastric fluid: 0.2 g/L
Interstitial, intracellular and perspiration fluid: 2 g/L
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- other: Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- - pH of simulated body fluids:
gastric fluid: 1.5 ± 0.1
interstitial fluid: 7.4 ± 0.2
intracellular fluid: 4.5- 5.0
perspiration fluid: 6.50
- Temperature (°C)
gastric, interstitial and intracellular fluid: 37 ± 1°C
perspiration fluid: 30 ± 1°C
- Agitation:
gastric, interstitial and intracellular fluid: Agitation speed 171 rpm on a temperature controlled orbital laboratory shaker (orbital size: 1 inch, 2.54 cm)
perspiration fluid: no agitation - Details on dosing and sampling:
- - Procedure: Test vessels with 50 mL of simulation fluid and 10 mg (gastric fluid) or 100 mg (other fluids) of the test item were covered with a stopper and placed into a thermostatic orbital shaker with (gastric, interstitial and intracellular fluid) or without agitation (perspiration fluid).
- Replicas:
gastric fluid: 3
interstitial, intracellular, and perspiration fluid: 6 (3 per sampling point)
- Analysis: Determination of dissolved chromium and lead concentrations icarried out using an ICP-MS with a reporting limit of 10 μg/L (accuracy: 90-110%) (analysis was not performed in accordance with GLP but according to the ISO 17025 standard) - Statistics:
- The between-vessel mean, standard deviation, coefficient of variation of the measured dissolved element concentrations are calculated.
Results and discussion
- Preliminary studies:
- Not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not applicable
- Details on distribution in tissues:
- Not applicable
- Details on excretion:
- Not applicable
Metabolite characterisation studies
- Details on metabolites:
- Not applicable
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Not applicable
Any other information on results incl. tables
The results of the bio-elution tests with C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are summarized in the table below.
Bio-elution testing |
Concentration |
% of chromium |
Concentration |
% of lead |
||||
Substance |
Bio-elution |
Loading |
Time |
pH |
Cr (μg/L) |
dissolved |
Pb (μg/L) |
dissolved |
C.I. Pigment Yellow.34 |
Gastric |
0.2 g/L |
2h |
pH 1.5 |
6382 |
23,64% |
28123 |
23,83% |
Interstitial |
2 g/L |
24 h |
pH 7.4 |
12543 |
|
57 |
|
|
2 g/L |
7d |
pH 7.4 |
22518 |
8,34% |
34 |
0,00% |
||
Intracellular |
2 g/L |
24 h |
pH 4.5 -5 |
6347 |
|
38117 |
|
|
2 g/L |
7d |
pH 4.5 -5 |
9294 |
3,44% |
49155 |
4,17% |
||
Perspiration |
2 g/L |
24 h |
pH 6.5 |
30 |
|
8628 |
|
|
2 g/L |
7d |
pH 6.5 |
180 |
0,07% |
19379 |
1,64% |
||
C.I. Pigment Red.104 |
Gastric |
0.2 g/L |
2h |
pH 1.5 |
6145 |
22,76% |
30047 |
25,46% |
Interstitial |
2 g/L |
24 h |
pH 7.4 |
163 |
|
215 |
|
|
2 g/L |
7d |
pH 7.4 |
3580 |
1,33% |
248 |
0,02% |
||
Intracellular |
2 g/L |
24 h |
pH 4.5 -5 |
10413 |
|
107598 |
|
|
2 g/L |
7d |
pH 4.5 -5 |
10188 |
3,77% |
110526 |
9,37% |
||
Perspiration |
2 g/L |
24 h |
pH 6.5 |
19 |
|
11280 |
|
|
2 g/L |
7d |
pH 6.5 |
206 |
0,08% |
21339 |
1,8% |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no data
The bio-elution potential of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 was determined in four kinds of simulated body fluids (gastric, interstitial, intracellular and perspiration fluid), to determine bioavailability of chrome and lead for absorption. Results show highest bio-elution in gastric fluid, in which 22-24% of chromium and 23-26% of lead dissolved. For chromium, the percentages dissolved were 8.34 and 1.33% in interstitial, 3.44 and 3.77% in intracellular and 0.07 and 0.08% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment 104 respectively. For lead, the percentages dissolved were 0 and 0.02% in interstitial, 4.17 and 9.37% in intracellular and 1.64 and 1.8% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 respectively. - Executive summary:
The bio-elution potential of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 was determined in four kinds of simulated body fluids (gastric, interstitial, intracellular and perspiration fluid), to determine bioavailability of chrome and lead for absorption. Incubation times were 2h for gastric fluid, and 24h and 7 days for interstitial, intracellular and perspiration fluid. Chrome and lead concentrations were measured by ICP-MS analysis.
Results show highest bio-elution in gastric fluid, in which 22-24% of chromium and 23-26% of lead dissolved. For chromium, the percentages dissolved were 8.34 and 1.33% in interstitial, 3.44 and 3.77% in intracellular and 0.07 and 0.08% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 respectively. For lead, the percentages dissolved were 0 and 0.02% in interstitial, 4.17 and 9.37% in intracellular and 1.64 and 1.8% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 respectively.
The values may be used to determine bioavailability of lead and chrome for absorption via the different exposure routes. The relatively high percentage of dissolved chrome and lead in simulated gastric fluid indicates that the highest bioavailability will result from oral exposure. Interstitial fluid may be a measure for dissolution in lung fluid and bioavailability after inhalation. The low dissolution of lead in this fluid indicates that lead will not be very bioavailable via this route, whereas for chromium bioavailability is relevant via inhalation. Bioavailability via dermal absorption may be indicated by dissolution in perspiration fluid. This is very low for chromium and therefore dermal absorption will not be relevant for chromium. Lead dissolution from C.I. Pigment Yellow 34 and C.I. Pigment Red 104 in perspiration fluid was less than 1.8%. Therefore, bioavailability for dermal absorption will also be very low.
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