Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25. Jul. 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
17.4 - 17.6 µm
Percentile:
D50
Mean:
17.5 µm
St. dev.:
0.09
Remarks on result:
other: mean of test series 1 and 2
Percentile:
D10
Mean:
7 µm
St. dev.:
0.02
Remarks on result:
other: mean of test series 1 and 2
Percentile:
D90
Mean:
43.8 µm
St. dev.:
0.19
Remarks on result:
other: mean of test series 1 and 2
Conclusions:
Median particle size of D50 = 17.5 µm
Executive summary:

Particle size distribution of the test substance was determined by laser diffraction measurement, according to the OECD Guideline 110 (1981) and ISO 13320 (2009).

The substance has a median particle size of D50 = 17.5 µm.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the melting point is above 300°C
Reason / purpose:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion