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
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