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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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-reference
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Performed to reliable standards to assess dust content.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Principles of method if other than guideline:
Seiving methods
GLP compliance:
no
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
No.:
#1
Size:
< 63 µm
Distribution:
ca. 15 %
No.:
#2
Size:
> 63 - < 250 µm
Distribution:
ca. 57 %
No.:
#3
Size:
> 250 µm
Distribution:
ca. 28 %
Conclusions:
Low dust content
Executive summary:

-      Retained by 250 µm = 15.27%

-      Retained by 63 µm =56.68%

-      < 63 µm =28.15%

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion