Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
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
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
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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 for cross-reference:
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 for cross-reference:
data waiving: supporting information

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion