Registration Dossier

Administrative data

Endpoint:
nanomaterial dustiness
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: DIN 55992-1:2006 ("Determination of a parameter for the dust formation of pigments and extenders - Part 1: Rotation method")
Principles of method if other than guideline:
- Principle of test: modified Heubach procedure
- Short description of test conditions: Heubach dust meter was modified in a way that a seven-stage cascade impactor was inserted instead of a filter.
- Parameters analysed / observed: dustiness, i.e. the proportion of dust arising from solid substances under processing, handling and transportation conditions. Dustiness is considered to reflect the potential of a substance to generate airborne dust after mechanicl stress applied via the dust generation device of the Heubach dust meter (rotating drum).
- Additionaly the dust fractions of the raw material was determined by the cascade impactor.
GLP compliance:
no
Type of method:
rotating cylinder

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform
Specific details on test material used for the study:
form: High surface area alumina (nanoform)

Results and discussion

Dustiness index
Mean:
607.75 other: mg/g
Remarks on result:
other: total dustiness of the nanoform by modified Heubach procedure

Any other information on results incl. tables

As a conclusion, for the nanoform, the respirable fraction represent 2.13% of the total dustiness generated under the Modified Heubach procedure.

Dustiness in accordance with DIN EN 481:

Total dustiness: 607.75 mg/g

Inhalable fraction: 381.26 mg/g (62.73 %)

Thoraic fraction: 105.65 (17.38 %)

Respirable fraction: 12.94 mg/g (2.13%)

Mass Median Aerodynamic Diameter (MMAD): 24.9 µm

Geometric Standard Deviation (GSD): 2.1 µm

Details on Dustiness:

Table: dust masses and flow values of the impactor stages

Impactor stage

 Average aerodyn. diameter [µm]

Calculated physical particles size [µm]

Separated dust mass [mg]

Pass [%]

Residue [%]

A

32.40

16.26

199.93

67.10

32.90

B

15.80

7.93

255.34

25.09

74.91

C

8.13

4.08

114.31

6.28

93.72

D

4.06

2.04

30.72

1.23

98.77

E

2.04

1.02

5.25

0.36

99.64

F

0.99

0.50

1.69

0.08

99.92

G

0.47

0.24

0.39

0.02

99.98

<G

<0.47

<0.24

0.12

 

 

Extrapolated total dust quantity: 606.96 mg

Total dust mass, including correction: 607.75 mg

Dust concentration after density correction: 3034.81 mg/m³

 

Table: Characteristics of frequency distribution

Particle size [µm]

Residue [%]

Average particle size d

Slope of cumulated particle size distribution D’

0.24

99.98

0.37

0.25

0.50

99.92

0.76

0.53

1.02

99.64

1.53

0.85

2.04

98.77

3.06

2.47

4.08

93.72

6.01

4.89

7.93

74.91

12.10

5.04

16.26

32.90

37.13

0.52

58.00

11.28

79.0

 

100.00

0.00

 

 

 

Dust masses and values of the sieve and impactor stages for the raw material

 

Sieve stage

Screen size [µm]

Particle size [µm]

Pass [%]

Residue [%]

1

200

200

100

0

2

100

100

96

4

3

63

63

86

14

 

Impactor stage

 Average aerodyn. diameter [µm]

Calculated physical particles size [µm]

Separated dust mass [mg]

Pass [%]

Residue [%]

A

32.40

16.26

55.00

31.95

68.05

B

15.80

7.93

15.52

12.74

87.26

C

8.13

4.08

6.63

4.54

95.46

D

4.06

2.04

2.04

2.02

97.98

E

2.04

1.02

0.70

1.14

98.86

F

0.99

0.50

0.54

0.47

99.53

G

0.47

0.24

0.29.

0.11

99.89

<G

<0.47

<0.24

0.09

 

 

Extrapolated total dust quantity: 80.81 mg

Total dust mass, including correction: 80.82 mg

Dust concentration after density correction: 404.06 mg/m³

Applicant's summary and conclusion