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Diss Factsheets

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EN 15051-2 (Workplace exposure. Measurement of the dustiness of bulk materials - Rotating drum method)
GLP compliance:
not specified
Type of method:
rotating cylinder
Details on methods and data evaluation:
The sample has been divided in eight equal lots of about 35 ml using a rotary riffler, this rotary riffler is especially designed to minimize the loss of any fine dust. One of these divided lots has been used for determining the bulk density and the moisture content as well. The bulk density of the sample has been determined by accurately weighing a volume of 100 cm3 after gentle tapping at the side. This bulk density is used to convert the sample mass to the required volume of approx. 35 cm3 and the sample is further divided to the required 35 cm3. A few grams of each sample have been placed in the moisture analyser and have been heated to 105°C until a stable mass has been reached. The relative mass loss so-obtained has been quantified as moisture content as an independent triplicate.

One of the divided sub lots of about 35 cm3 is accurately weighed and placed in the rotating drum and the airborne dust particles are transferred by an air flow rate of 38 l min-1 to the filter assembly during 1 minute. The airborne dust released is drawn from the dust generation section, through the dust transfer section, into the special designed foam/filter assembly with successively 20 pores per inch foam, 80 pores per inch foam and a glass fibre backing filter. The complete procedure is repeated several times with fresh sample material and clean filters, each dustiness measurement is preceded by a blank run. Dustiness is a relative term and the result obtained will depend on the used test apparatus, the properties of the material and various environmental variables.
Sampling:
The dust sampling system of the EN 15051-2 Rotating Drum method is constructed in such a way that the largest airborne particles are collected on a foam filter with 20 pores per inch foam. Smaller airborne particles pass through this filter and are collected on a second foam filter with 80 pores per inch foam. Only the smallest airborne particles pass through both foam filters and are collected on a glass fibre backing filter. The dust collected on the glass fibre backing filter is presented as the respirable fraction.
In accordance with the respirable convention described in ISO 7708 the adult respirable fraction shown in Figure 1 is given by a cumulative log-normal distribution with a median diameter of 4.25 μm and a geometric standard deviation of 1.5.2 This results that 100% of the particles with an aerodynamic diameter < 16 μm are classified as respirable and it is assumed that these particles are all collected on the glass fibre backing filter.
According to the respirable convention, 98.7% of the particles collected by the EN 15051 methodology on this glass fibre backing filter then have an aerodynamic particle diameter ≤ 10 μm.

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
EC Number:
309-916-8
EC Name:
Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
Cas Number:
101357-19-1
Molecular formula:
Reaction mass of C25 H30 N3. P Moy Wz O40 (y +z = 12) , C24 H28 N3. P Moy Wz O40 (y +z = 12) and C23 H26 N3. P Moy Wz O40 (y +z = 12)
IUPAC Name:
Reaction mass of [4-[bis[4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates, [4-[[4-(dimethylamino)phenyl]-[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates and [4-[bis[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates
Test material form:
solid: nanoform, no surface treatment
Details on test material:
SOURCE OF TEST MATERIAL
-Product number: 0345N (skin sensitisation, OECD 422, eye irritation, acute oral toxicity)
0345F (Ames test)

- Purity Preparation containing ≥80% (treat as 100%)
- Physical form/colour: Violet powder
- Expiry date: Stable for at least 5 years from delivery date

-Shape Category: spheroidal
-Shape: spherycal
-pure shape: yes
-Typical composition: ca. 100%
-range >50 and < 100%

-D10, typical value: 30 nm, range: >1.5 and < 50nm
-D50, typical value: 45 nm, range: >15 and <100nm
-D90, typical value: 60nm, range: >25 and < 150nm

-Fraction in size range 1-100nm: > 50 and <100%

-Crystallinity:
Structure:
amorphous, pure structure

-SSA: BET surface area typically ca. 32-40 m2/g for product number 345F and 0345N)
Range > 10 and < 200 m2/g

-.no surface treatment

Storage conditions: Stored at ambient conditions in the dark (away from direct light)
- Safety precautions: Routine hygienic procedures (nitrile gloves, goggles, face mask)





Data gathering

Instruments:
15051 rotating drum dustiness tester
Reproducibility:
The average relative standard deviation (RSD) of the intra RSD is typically below 17%. The relative standard deviations obtained for the independent measurements are all below 8 % and are thus well within the range of RSD values typically found for this methodology, confirming adequate sampling.

Results and discussion

Dustiness indexopen allclose all
Mean:
ca. 34 833 mg/kg
St. dev.:
7.5 other: %7.5
Remarks on result:
other: inhalable fraction
Mean:
ca. 6 569 mg/kg
St. dev.:
7.5 other: %
Remarks on result:
other: thoracic fraction
Mean:
ca. 729 mg/kg
St. dev.:
6.8 other: %
Remarks on result:
other: respirable fraction

Applicant's summary and conclusion

Conclusions:
The substance was tested for dustiness for nanomaterials, following EN15051-2 rotatinfg drum equipment. Under the experimental conditions the test item has the following results, ca. 34833 mg kg-1 for the inhalable fraction, 6569 mg kg-1 for the thoracic fraction and 729 mg kg-1 for the respirable fraction.
Executive summary:

The substance was tested for dustiness for nanomaterials, following EN15051-2 rotatinfg drum equipment. Under the experimental conditions the test item has the following results, ca. 34833 mg kg-1 for the inhalable fraction, 6569 mg kg-1 for the thoracic fraction and 729 mg kg-1 for the respirable fraction.