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Nanomaterial dustiness

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nanomaterial dustiness
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2020-11-16 to 2020-12-03
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Report date:
Reference Type:
Harmonised classification and labelling of titanium dioxide (TiO₂) - Content of particles with aerodynamic diameter ≤ 10 μm - Methods and results of analysis
Bibliographic source:
Report date:

Materials and methods

Test guideline
according to guideline
EN 15051-2 (Workplace exposure. Measurement of the dustiness of bulk materials - Rotating drum method)
not specified
GLP compliance:
Type of method:
rotating cylinder
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Titanium dioxide
EC Number:
EC Name:
Titanium dioxide
Cas Number:
Molecular formula:
Test material form:
solid: nanoform
Details on test material:
All information below taken from: TDMA (2022) Analytical Report on Samples studied in TDMA Grouping Hypothesis testing. TDMA1072

Details on test material:

Sample ID: G6-3
Coating: coated with Al-oxide and hydrophobic organic

SSA: 70 m²/g
skeletal density: 2.796 g/cm³
VSSA: 195.7 m²/cm³
pH (1wt% in deionised water): 6.2
isoelectric point (pH): 7.5
agglomerate density: 1.35 g/cm³

Crystal phase (XRD): 100% rutile

population d50 (SEM, ISO 19749): 9.2 ±2.0
% below 100 nm (SEM, ISO 19749): 100
shape (SEM, ISO 19749): Spindle
aspect ratio (SEM, ISO 19749): 3.24

Chemical Composition, Quantitative bulk chemical analysis (ICP-MS, ASTM D5291):
Sample ID P Al SiO2 C S Cl W
ppm % % % ppm ppm ppm
G6-3 <100 3.57 0.021 7.3 <300 <300 <100

The following elements were analysed but were not detected at levels above the detection limit (100ppm except F and Br 300ppm) :
As, Ag, Au, Be, Ba, Bi, Br, Cd, Co, Cr, Cu, F, Ga, Ge, Hf, Hg, In, Li, Mn, Mo, Ni, Pb, Re, Sb, S, Sn, Sr, Ta, Te, Th, V, Zn.

Inorganic surface composition analysed by X-Ray Photoelectron Spectroscopy (XPS), organic surface treatments identified using 1H and 13C solid state NMR:
Sample ID C O Ti Si Al K Na Nb Zr N P S Cl W
at% at% at% at% at% at% at% at% at% at% at% at% at% at%
G6-3 68.1 22.7 5.85 ND 3.2 ND 0.01 ND ND ND 0.12 0.09 ND
ND = Not detected

Results and discussion

Dustiness indexopen allclose all
Key result
0.38 other: % wt
Remarks on result:
other: content of particles with aerodynamic diameter <= 10µm
< 10 mg/kg
Remarks on result:
other: Respirable dustiness
3 836 mg/kg
Remarks on result:
other: Thoracic dustiness
8 386 mg/kg
Remarks on result:
other: Inhalable dustiness

Any other information on results incl. tables

TDMA (2021):

The percent particles below 10 μm aerodynamic diameter using `EN 15051-2 - Measurement of the dustiness of bulk materials - Part 2: Rotating drum method´ are taken from the thoracic mass fraction collected from the 80 pore per inch metal foam and filter. The dustiness result is normally expressed in mg/kg and therefore it is converted to % wt. by dividing by 10 000 in line with the text of the classification of TiO2:

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G6-3 is 0.38 % wt (determined by the rotating drum method according to EN 15051-2).


Brown (2020)

Category of Dustiness (classified by the EN15051-2 test method):

- Inhalable dustiness mass fraction [mg/kg]: very low < 300; low 300 – 650; moderate 650 – 3000; high > 3000

- Thoracic dustiness mass fraction [mg/kg]: very low < 80; low 80 – 300; moderate 300 – 1000; high > 1000

- Respirable dustiness mass fraction [mg/kg]: very low < 10; low 10 – 60; moderate 60 – 210; high > 210

Dustiness of the test item G6-3 (triplicate analysis):

- Average material weight charged to the drum: 11.66 g for 35 cm³

- Inhalable dustiness: high (8386 mg/kg)

- Thoracic dustiness: high (3836 mg/kg)

- Respirable dustiness: very low (<10 mg/kg)

Applicant's summary and conclusion

The test item G6-3 has a high (8386 mg/kg) inhalable dustiness, a high (3836 mg/kg) thoracic dustiness and a very low (<10 mg/kg) respirable dustiness.

The content of particles with aerodynamic diameter ≤ 10 μm for the sample G6-3 was 0.38 % wt (EN 15051-2). On the basis of the classification criteria for titanium dioxide (Regulation (EC) 2020/217), this titanium dioxide nano form does not require a classification as a category 2 carcinogen. For further details please refer to the attached analysis report in the endpoint summary for nanomaterial dustiness (IUCLID section 4.28.8).