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Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is marketed or used in a non solid or granular form
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The substance is described as a hygroscopic solid, where the crystals are sticked together due to moisture. So, study with laser diffraction or sieving methods is technically not feasible.
Moreover, the substance will not be marketed as such. Therefore, no further information is considered necessary.
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint:
particle size distribution (granulometry)
Type of information:
other: Statement
Remarks:
based on the appearance of the test item according to international guidelines criteria
Adequacy of study:
supporting study
Study period:
25 June 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
May 12, 1981
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 59
Version / remarks:
CIPAC, Physico-chemical Methods for Technical and Formulated Pesticides, MT 59: "Sieve Analysis";
CIPAC Handbook Volume F, 1995.
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Version / remarks:
CIPAC, Physico-chemical Methods for Technical and Formulated Pesticides, MT 187: “Particle Size
Analysis by Laser Diffraction”; CIPAC Handbook Volume K, 2003.
GLP compliance:
yes
Remarks:
(no certificate in report)
Remarks on result:
not determinable

The test item is a hygroscopic powder which forms one large lump and cannot be analysed by laser diffraction due to the moisture in the test item. In the laser diffraction analysis, a dispersing solvent (e.g. acetone or sunflower oil) is used and the moisture droplets formed in this solvent, interfere the measurement of particle size of the crystals. Sieving is not an alternative since the test item sticks to the sieves.

Based on this, it is concluded that it is technically not possible to determine the particle size distribution of this substance in the form in which it was supplied.

Conclusions:
Granulometry cannot be determined due to the hygroscopic nature of the substance.
Executive summary:

A statement was performed to conclude on the granulometry of the test item.

The substance was assessed according to recognized guidelines (OECD 110, ISO 13320, CIPAC MT59 and MT180) and under GLP.

The test item is hygroscopic; therefore, because of moisture, the particles are sticked together. Thus, laser diffraction or sieving methods are not applicable.

Description of key information

Granulometry cannot be determined due to the hygroscopic nature of the substance.

Moreover, the substance will not be marketed as such. Therefore, no further information is considered necessary.

Additional information

A statement was performed to conclude on the granulometry of the test item.

The substance was assessed according to recognized guidelines (OECD 110, ISO 13320, CIPAC MT59 and MT180) and under GLP.

The test item is described as a hygroscopic solid; therefore, because of moisture, the particles are sticked together. Thus, study with laser diffraction or sieving methods is technically not feasible.