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EC number: 231-869-6 | CAS number: 7773-01-5
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption 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 conducted to GLP standard and a current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Remarks:
- deviations to study plan were indicated in report, but these are not considered deviations in the OECD guideline followed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Manganese dichloride
- EC Number:
- 231-869-6
- EC Name:
- Manganese dichloride
- Cas Number:
- 7773-01-5
- Molecular formula:
- Cl2Mn
- IUPAC Name:
- manganese(2+) dichloride
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin:Biopredic, Rennes (France).
- Type of skin: human skin
- Preparative technique: dermatomized
- Thickness of skin (in mm): 0.47-0.628
- Membrane integrity check: determined by measuring the impedance (resistance to alternating current) before the treatment and at the end of the experiment after 24 hours
- Storage conditions:The formulation samples (at least 5 mL each) together with a sample list were sent on dry ice to Itingen, Switzerland. Samples were stored at -20 °C after receipt. After thawing the samples were resolved using an ultrasonic bath.
PRINCIPLES OF ASSAY
- Diffusion cell:glass flow-through diffusion chambers with a diameter of 1.135 cm. These chambers are subdivided in an upper part (donor chamber) and in a lower part (receptor chamber)
- Receptor fluid: PBS
Composition of PBS:
16.0 g NaCl
0.4 g KCl
0.4 g KH2PO4
0.376 g Na2H PO4 x 2H2O
in 2 L deionised water
- Solubility of test substance in receptor fluid: not assessed, but has high water solubility
- Flow-through system: yes.
- Test temperature:The test item was analysed in 12 replicates (4 donors) under dynamic conditions. The receptor solution was pumped with a flow rate of 0.8 – 1.1 mL/h.
- Reference substance(s):Benzoic acid and 2-Ethylhexyl trans-4-methoxycinnamate
-
Results and discussion
- Absorption in different matrices:
- - Non-occlusive cover + enclosure rinse:
- Receptor fluid, receptor chamber, donor chamber (in vitro test system): Experiment 1: Receptor chamber 1 = 7.08; chamber 2 = 3.98; chamber 3 = 0.481; chamber 4=48.4; chamber 5 = 21.9;chamber 6 = 0.381 Experiment 2: chamber 1 = 0.138;chamber 2 = 13.8; chamber 3 = 0.151; chamber 4 = 2.05; chamber 5 = 0.251; chamber 6 = 0.399
- Skin preparation (in vitro test system): Epidermis mean 0.202%, dermis mean 0.314%
- Stratum corneum (in vitro test system): not assessed as not bioavailable - Total recovery:
- - Total recovery:
- Recovery of applied dose acceptable: 96.6% mean
- Limit of quantitative determination :0.099 µg/mL for MnCl2 or 0.04 µg/mL for Mn
Percutaneous absorptionopen allclose all
- Parameter:
- percentage
- Absorption:
- ca. 0.79 %
- Remarks on result:
- other: 24 hr
- Remarks:
- Based on application of 55/126 to convert from MnCl2 to Mn absorbed
- Parameter:
- percentage
- Absorption:
- ca. 0.19 %
- Remarks on result:
- other: 8 hr
- Remarks:
- Based on 58.7 µg/mL equal to 1.8% MnCl2, extrapolated to the mean value of measured concentration in chambers for experiments 1 and 2. The application of a factor of 55/126 to convert to Mn.
- Conversion factor human vs. animal skin:
- Not applicable
Any other information on results incl. tables
Experiment 1
Chamber |
Sample |
Time |
|
|
Volume |
Total |
|
No. |
Point |
Conc. |
Conc. |
|
amount |
|
|
[hours]/ |
measured |
corrected |
|
|
|
|
description |
[µg/mL] |
[µg/mL] |
[mL] |
[µg] |
1 |
1 |
KBL |
< LLOQ |
0.10 |
4.46 |
nd |
2 |
2 |
< LLOQ |
0.10 |
5.35 |
nd |
|
3 |
3 |
< LLOQ |
0.10 |
4.68 |
nd |
|
4 |
4 |
< LLOQ |
0.10 |
4.90 |
nd |
|
5 |
5 |
< LLOQ |
0.10 |
5.43 |
nd |
|
6 |
6 |
< LLOQ |
0.10 |
4.97 |
nd |
|
|
|
|
Mean |
0.10 |
4.96 |
nd |
1 |
13 |
0.5 |
< LLOQ |
0.10 |
2.02 |
0.20 |
2 |
14 |
< LLOQ |
0.10 |
2.03 |
0.20 |
|
3 |
15 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
4 |
16 |
< LLOQ |
0.10 |
2.01 |
0.20 |
|
5 |
17 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
6 |
18 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
|
|
|
Mean |
0.10 |
2.02 |
0.20 |
1 |
19 |
2 |
< LLOQ |
0.10 |
2.02 |
0.20 |
2 |
20 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
3 |
21 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
4 |
22 |
< LLOQ |
0.10 |
2.03 |
0.20 |
|
5 |
23 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
6 |
24 |
< LLOQ |
0.10 |
2.02 |
0.20 |
|
|
|
|
Mean |
0.10 |
2.02 |
0.20 |
1 |
25 |
4 |
0.70 |
0.70 |
2.06 |
1.44 |
2 |
26 |
< LLOQ |
0.10 |
2.55 |
0.25 |
|
3 |
27 |
< LLOQ |
0.10 |
2.04 |
0.20 |
|
4 |
28 |
0.20 |
0.20 |
2.07 |
0.42 |
|
5 |
29 |
< LLOQ |
0.10 |
2.07 |
0.20 |
|
6 |
30 |
< LLOQ |
0.10 |
2.31 |
0.23 |
|
|
|
|
Mean |
0.22 |
2.18 |
0.46 |
nd = not determined
KBL = chamber blank
LLOQ = 0.099 µg/mL
Chamber |
Sample |
Time |
|
|
Volume |
Total |
|
No. |
Point |
Conc. |
Conc. |
|
amount |
|
|
[hours]/ |
measured |
corrected |
|
|
|
|
description |
[µg/mL] |
[µg/mL] |
[mL] |
[µg] |
1 |
31 |
8 |
5.87 |
5.87 |
4.24 |
24.9 |
2 |
32 |
0.55 |
0.55 |
5.03 |
2.78 |
|
3 |
33 |
< LLOQ |
0.10 |
3.46 |
0.34 |
|
4 |
34 |
8.36 |
8.36 |
4.02 |
33.6 |
|
5 |
35 |
2.90 |
2.90 |
4.14 |
12.0 |
|
6 |
36 |
< LLOQ |
0.10 |
4.61 |
0.46 |
|
|
|
|
Mean |
2.98 |
4.25 |
12.3 |
1 |
37 |
12 |
4.52 |
4.52 |
3.95 |
17.8 |
2 |
38 |
1.50 |
1.50 |
4.83 |
7.25 |
|
3 |
39 |
0.22 |
0.22 |
3.50 |
0.75 |
|
4 |
40 |
41.5 |
41.5 |
3.93 |
163 |
|
5 |
41 |
1.89 |
1.89 |
4.07 |
7.69 |
|
6 |
42 |
< LLOQ |
0.10 |
4.22 |
0.42 |
|
|
|
|
Mean |
8.29 |
4.08 |
32.8 |
1 |
43 |
16 |
5.05 |
5.05 |
3.65 |
18.4 |
2 |
44 |
3.00 |
3.00 |
4.71 |
14.1 |
|
3 |
45 |
0.58 |
0.58 |
3.46 |
2.02 |
|
4 |
46 |
85.0 |
85.0 |
3.95 |
336 |
|
5 |
47 |
43.9 |
43.9 |
4.08 |
179 |
|
6 |
48 |
ns |
|
|
|
|
|
|
|
Mean |
27.5 |
3.97 |
110 |
1 |
49 |
20 |
6.63 |
6.63 |
3.61 |
23.9 |
2 |
50 |
3.28 |
3.28 |
4.62 |
15.1 |
|
3 |
51 |
0.71 |
0.71 |
3.53 |
2.50 |
|
4 |
52 |
101 |
101 |
4.02 |
407 |
|
5 |
53 |
56.1 |
56.1 |
4.12 |
231 |
|
6 |
54 |
ns |
|
|
|
|
|
|
|
Mean |
33.59 |
3.98 |
136 |
LLOQ = 0.099 µg/mL
ns = no sample
Chamber |
Sample |
Time |
|
|
Volume |
Total |
|
No. |
Point |
Conc. |
Conc. |
|
amount |
|
|
[hours]/ |
measured |
corrected |
|
|
|
|
description |
[µg/mL] |
[µg/mL] |
[mL] |
[µg] |
1 |
55 |
23 |
5.87 |
5.87 |
2.83 |
16.6 |
2 |
56 |
5.34 |
5.34 |
3.63 |
19.4 |
|
3 |
57 |
0.63 |
0.63 |
2.68 |
1.68 |
|
4 |
58 |
62.8 |
62.8 |
2.99 |
188 |
|
5 |
59 |
39.6 |
39.6 |
3.14 |
124 |
|
6 |
60 |
< LLOQ |
0.10 |
2.10 |
0.21 |
|
|
|
|
Mean |
19.1 |
2.89 |
58.3 |
1 |
61 |
24 |
6.51 |
6.51 |
5.28 |
34.4 |
2 |
62 |
7.21 |
7.21 |
5.45 |
39.3 |
|
3 |
63 |
0.74 |
0.74 |
5.26 |
3.87 |
|
4 |
64 |
85.7 |
85.7 |
5.02 |
430 |
|
5 |
65 |
30.1 |
30.1 |
4.29 |
129 |
|
6 |
66 |
< LLOQ |
0.10 |
4.92 |
0.49 |
|
|
|
|
Mean |
21.71 |
5.04 |
106 |
1 |
79 |
Washing solution |
43.8 |
43.8 |
50.0 |
2192 |
2 |
80 |
79.0 |
79.0 |
50.0 |
3949 |
|
3 |
81 |
78.1 |
78.1 |
50.0 |
3904 |
|
4 |
82 |
11.6 |
11.6 |
50.0 |
582 |
|
5 |
83 |
49.6 |
49.6 |
50.0 |
2481 |
|
6 |
84 |
43.7 |
43.7 |
50.0 |
2187 |
|
|
|
|
Mean |
51.0 |
50.0 |
2549 |
1 |
103 |
Epidermis |
4.65 |
4.65 |
5.00 |
23.3 |
2 |
104 |
3.31 |
3.31 |
5.00 |
16.5 |
|
3 |
105 |
0.54 |
0.54 |
5.00 |
2.71 |
|
4 |
106 |
15.1 |
15.1 |
5.00 |
75.4 |
|
5 |
107 |
5.27 |
5.27 |
5.00 |
26.3 |
|
6 |
108 |
0.36 |
0.36 |
5.00 |
1.79 |
|
|
|
|
Mean |
4.87 |
5.00 |
24.34 |
LLOQ = 0.099 µg/mL
See overall remarks and attachments for experiment 2 results.
Applicant's summary and conclusion
- Conclusions:
- Manganese chloride demonstrated very low dermal absorption at 0.79% Mn2+ over 24 hours.
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.
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