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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 11th, 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The usage of information on Direct Blue 199 Na/NH4, which has the same main component and with a different counter ion, can be considered as suitable and appropriated because the difference in salification is expected to not influence the characteristics related to the specific end-point.
The impurity profile does not impact on the read across proposed. Details on the approach followed are included in the document attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Standard ISO 13320: 2009 Particle size analysis - Laser diffraction methods, First edition 2009-10-01
Deviations:
no
Principles of method if other than guideline:
Laser diffraction method.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
ca. 39.9 µm
Percentile:
D10
Mean:
20.2 µm
St. dev.:
0.5
Percentile:
D90
Mean:
64.6 µm
St. dev.:
2

Measured values

Determination Median
(µm)		 Diameter on cumulative 90 %
(µm)		 Diameter on cumulative 10 %
(µm)		 Span
(-)
1 41.7 68.8 20.6 1.2
2 39.9 64.6 20.2 1.1
3 40.3 64.9 20.3 1.1
4 39.5 65.4 19.9 1.2
5 38.5 63.5 19.3 1.1
Average 40.0 65.4 20.1 1.1
Standard deviation 1.2 2.0 0.5 0.0
Extended uncertainty 2.4 4.0 1.0 -

The value nearest to average was use as the final result of the test. That was the 2nd measurement.

Standard uncertainty is equal to one standard deviation.

Extended uncertainty was calculated by using coefficient 2.

Conclusions:
MMAD: 39.9 µm
Executive summary:

The particle size distribution ofthe test substance was determined using the laser diffraction method. The procedures used in the study were in accordance with Guidance Document on the Determination of Particle Size Distribution, Fibre Length and Diameter Distribution of Chemical Substances, EUR 20268 EN (2002) and Standard ISO 13320: 2009 Particle size analysis - Laser diffraction methods, First edition 2009-10-01.

Particle size distribution of test substance is characterized by the Median Diameter of 39.9 µm, a diameter in cumulative 90 % of 64.6 µm and a diameter on cumulative 10 % of 20.2 µm.

Conclusion

MMAD: 39.9 µm

Description of key information

MMAD: ca 39.9 µm

Additional information

Laser diffraction method.