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Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

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:
2013

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

Constituent 1
Reference substance name:
C.I. Pigment Yellow 34
IUPAC Name:
C.I. Pigment Yellow 34
Constituent 2
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
Constituent 3
Chemical structure
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
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.