Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 June 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to other study
Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 June 2016
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:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to
Guideline:
other: CIPAC MT 187 (Particle size analysis by laser diffraction)
Principles of method if other than guideline:
According to REACH 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 regulation (EC) No 440/2008. OECD 110 TG ‘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 Guidance on information requirements and Chemical Safety Assessment-Chapter R.7a stipulates that many methods are available for particle size measurements but none of them is applicable to the entire size range. The guidance mentions Laser scattering/diffraction as a method for particles of all kind and makes reference to ISO 13320:2009.
According to Guidance document EUR 20268 (2002), the laser diffraction technique is applicable to particles of respirable and inhalable size. The MMAD can be calculated.
GLP compliance:
yes (incl. certificate)
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: 1.41

Mass median aerodynamic diameter:
118.094 µm
Geometric standard deviation:
>= 6.36 - <= 6.449
Remarks on result:
other: The MMAD value is the mean of 5 measurements. 'St.dev.' in table below is the population standard deviation [µm].
Key result
Percentile:
D10
Mean:
9.087 µm
St. dev.:
0.128
Key result
Percentile:
D50
Mean:
99.453 µm
St. dev.:
2.031
Key result
Percentile:
D90
Mean:
326.472 µm
St. dev.:
6.605
No.:
#1
Size:
< 10 µm
Distribution:
10.91 other: vol%

Coefficient of variation for D50 is < 3%; D10 and D90 are < 5%. These values are within the acceptable limits mentioned in the ISO 13320 standard.

VISUAL OBSERVATION

The substance was observed to be a medium to fine, free flowing brown powder with clusters. At 100x magnification under a microscope, the particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 240 μm. At 400x magnification, the sample was observed to be made up of single crystalline particles with agglomerations.

Conclusions:
Particle size distribution of the substance: D10= 9.09 µm, D50= 99.5 µm and D90= 326 µm. 10.9% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 118 µm.

Executive summary:

The particle size distribution of the substance was determined using laser diffraction analysis (dry powder module) in a GLP study according to ISO 13320 and CIPAC MT 187.

Each result is the average of five runs. Particle size distribution of the substance: D10= 9.09 µm, D50= 99.5 µm and D90= 326 µm. 10.9% by volume was determined to be smaller than 10 µm. The MMAD was determined to be 118 µm.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Appearance was determined by visual observation.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: yellow/brown powder
- Storage conditions: in refrigerator (2-8°C)

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Key result
Form:
solid: particulate/powder
Colour:
brown
Odour:
other: not determined
Substance type:
organic

Applicant's summary and conclusion

Conclusions:
The substance is a brown powder.
Executive summary:

The substance is a solid. The substance was visually observed to be a fine, free flowing brown powder with clusters.