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Diss Factsheets

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

Constituent 1
Chemical structure
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
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.