Calcination products of BaCO3, SrCO3, MgO, Al2O3, Eu2O3 and MnCO3

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 19, 2015 - December 9, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Qualifier:

according to guideline

Guideline:

other: CIPAC MT 187 (Particle size analysis by laser diffraction)

Principles of method if other than guideline:

According to REACH Regulation (EC) No 1907/2006, Article 13(3), tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. No particle size distribution test method is laid down in the relevant Regulation (EC) No 440/2008. The international OECD 110 test guideline ‘Particle Size Distribution/FibreLength and Diameter Distributions’ dates from 1981 and describes two methods in detail; both methods have restrictions and are not applicable to the entire size range. ECHA’s document ‘Guidance on information requirements and Chemical SafetyAssessment-Chapter R.7a: Endpoint specific guidance’ stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. ECHA’s guidance mentions the Laser scattering/diffraction as a method suitable for particles of all kind and makes reference to ISO 13320:2009.

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Type of distribution:

volumetric distribution

Specific details on test material used for the study:

Relative density used: 3.79

Mass median aerodynamic diameter:

10.827 µm

Geometric standard deviation:

>= 1.963 - <= 1.968

Remarks on result:

other: Mass median aerodynamic diameter (MMAD) is the mean of 5 measurements.

Key result

Percentile:

D10

Mean:

2.146 µm

St. dev.:

0.01

Remarks on result:

other: St.dev. = population standard deviation [µm]

Key result

Percentile:

D50

Mean:

5.562 µm

St. dev.:

0.012

Remarks on result:

other: St.dev. = population standard deviation [µm]

Key result

Percentile:

D90

Mean:

11.089 µm

St. dev.:

0.021

Remarks on result:

other: St.dev. = population standard deviation [µm]

No.:

#1

Size:

< 10 µm

Distribution:

85.74 %

Remarks on result:

other: see the attached document for more details

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:

In a GLP-compliant study in accordance with ISO 13320:2009 and CIPAC MT 187 using the laser diffraction analysis dry powder module, the particle size distribution of the substance was determined as follows: 85.74% is < 10.00 µm; 10% is < 2.15 µm; 50% is < 5.56 µm and 90% is < 11.1 µm. The MMAD is 10.83 µm.

Description of key information

The particle size distribution of a sample of the substance was determined as follows: 85.74% is < 10 µm; 10% is < 2.15 µm; 50% is < 5.56 µm and 90% is < 11.1 µm. The MMAD is 10.83 µm.

Additional information

Determined in a GLP-compliant study in accordance with ISO 13320:2009 and CIPAC MT 187 using laser diffraction.