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
Justification for type of information:
The substance has a very low vapour pressure and low dust content.
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Version / remarks:
Method B
Deviations:
no
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Mass median aerodynamic diameter:
14.02 µm
Remarks on result:
other: concerning spherical volume
Key result
Percentile:
D50
Mean:
14.02 µm
Remarks on result:
other: Median diameter corresponds to MMAD (Mass Median Aerodynamic Diameter) as spherical particles.(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
No.:
#1
Size:
3 - 5 µm
Distribution:
5.92 %
No.:
#2
Size:
5 - 100 µm
Distribution:
93.99 %

The sample was first sieved by a 100 µm sieve:

- weighted sample: 0.77073 g

- weight fraction <100 µm: 0.00114 g

- mass fraction <100 µm: 0.15 %

The mass fraction <100 µm was 0.15 %, and was investigated by scanning electron microscopy. The median aspect ratio was 1.44.

The median diameter of the particle size is given for the fraction <100 µm. The value 14.02 µm was calculated for sherical particles.

 Accounting based on the total sample weight 
 Particle Size Spherical Volume [%]
  <4 µm (respirable)  0.00
  4 - 10 µm (thoracic) 0.88
  10 - 100 µm (inhalable) 92.70
> 100 µm  6.42
 Median (diameter µm)

 14.02

   

Conclusions:
The MMAD (Mass Median Aerodynamic Diameter < 100 μm) has a value of 14.02 μm as spherical particles. All particles with a mean diameter less than 100µm have a mass fraction of 0.15 %. 5.92 % of this mass fraction has a mean diameter less than 5 μm.
Executive summary:

According to OECD guideline 110, the particle size distribution of 1,4-dihydroxyanthraquinone was determined by scanning eletron microscopy method for the sieved fration and presented on the basis of calculated mass fractions referring to the total sample weight. All particles with a mean diameter less than 100 µm have a mass fraction of 0.15 %. 5.92 % of this mass fraction has a mean diameter less than 5 μm. The mass mediam diameter is 14.02 µm (spherical volume).

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
vapour pressure
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of method:
other: no data
Temp.:
25 °C
Vapour pressure:
0 Pa
Conclusions:
The vapour pressure of the substance is 0.000133 Pa at 25°C.
Executive summary:

The vapour pressure of the substance is 0.000133 Pa at 25°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion