Registration Dossier

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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The study does not need to be conducted because substance's particle size is for 100% >100 μm.
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
Study period:
November 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
other: ASTM D1921
Deviations:
not specified
GLP compliance:
no
Type of method:
sieving
Type of distribution:
mass based distribution
No.:
#1
Size:
>= 2 mm
Distribution:
0 %
No.:
#2
Size:
>= 1.4 mm
Distribution:
0.1 %
No.:
#3
Size:
>= 0.6 mm
Distribution:
43.4 %
No.:
#4
Size:
>= 0.4 mm
Distribution:
36.9 %
No.:
#5
Size:
>= 0.2 mm
Distribution:
19.3 %
No.:
#6
Size:
>= 0.15 mm
Distribution:
0.3 %
Conclusions:
In a sief test performed according to ASTM D1921, the particle size of Potassium ferricyanide was determined to be ≥ 0.15 mm. Particle sizes were distributed as follows: 43.4% ≥0.6 mm, 36.9% ≥0.4 mm and 19.3% ≥0.2 mm.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion