Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-433-3 | CAS number: 12003-65-5
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-06-07
- 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
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
- Remarks on result:
- not measured/tested
- Percentile:
- D10
- Mean:
- 0.28 µm
- Remarks on result:
- other: no St.dev. was stated
- Percentile:
- D50
- Mean:
- 1 µm
- Remarks on result:
- other: no St.dev. was stated
- Percentile:
- D90
- Mean:
- 3.02 µm
- Remarks on result:
- other: no St.dev. was stated
- Conclusions:
- Aluminium lanthanum trioxide has folllowing particle size distribution:
D10: 0.28 µm
D50: 1.0 µm (max < 1.5 µm)
D90: 3.02 µm
D100: 7.8 µm (max < 10.0 µm) - Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-02 to 2016-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- DIN 55992-1 (Determination of a parameter for the dust formation of pigments and extenders - Part 1: Rotation method)
- Version / remarks:
- 2006
- Deviations:
- yes
- Remarks:
- seven stage cascade impactor connected to a heubach dust meter
- Principles of method if other than guideline:
- The Heubach dust meter is modified in a way that a seven stage cascade impactor is connected to the system. This involves an additional air fed of 20 L/min via the coarse dust separator needed to supply the cascade impactor with 40 L/min air current as specified in the manufacturer’s specifications.
The calculation report: EBRC (2016)
The Multiple-Path Particle Dosimetry Model (MPPD, v2.11; ART, 2009) was used to predict this fractional deposition behaviour for workers.
The model algorithms calculate the deposition (and clearance) of mono-disperse and polydisperse aerosols in the respiratory tract for particles ranging from ultra-fine (0.01 microns) to coarse (20 microns) sizes. Within each airway, deposition is calculated using theoretically derived efficiencies for deposition by diffusion, sedimentation and impaction within the airway or airway bifurcation. Filtration of aerosols by the head is determined using empirical efficiency functions. - GLP compliance:
- no
- Type of method:
- rotating drum method
- Type of distribution:
- volumetric distribution
- Remarks on result:
- other: MMAD1: 4.03 µm (p1: 15%, GSD2: 1.10); MMAD2: 100µm (p2: 85%, GSD2: 9.83)
- Remarks on result:
- not measured/tested
- Conclusions:
- Total dustiness (DMT): 32.8 mg/g
MMAD1 = 4.03 µm, GSD1 = 1.10, p1= 15 %
MMAD2 = 100 µm, GSD2 = 9.83, p2 = 85 %
Fractional deposition in human respiratory tract:
Head (ET): 43.00 %
Tracheobronchial (TB): 0.66 %
Pulmonary (PU): 1.79 %
Referenceopen allclose all
Total dustiness (DMT): 32.8 mg/g.
In the original study report by DMT, the mass median diameter was not calculated. Since the deposited fractions were provided for each of the cascade impactor stages, it was possible to fit a bi-modal lognormal distribution (weighed by the factor p ) to the data by standard non-linear regression procedure. The MMADs, GSDs and faktors were calculated as follows:
MMAD1 = 4.03 µm, GSD1 = 1.10, p1= 15 %
MMAD2 = 100 µm, GSD2 = 9.83, p2 = 85 %
As the cascade impactor already takes aerodynamic characteristics of the particles into account, the reported mass median diameter can be interpreted as the mass median aerodynamic diameter. These data and the corresponding GSDs were used as distribution parameters for the MPPDs model enabling an estimation of deposited dust fractions in the human respiratory tract:
These fractions were estimated as follows:
Head (ET): 43.00 %
Tracheobronchial (TB): 0.66 %
Pulmonary (PU): 1.79 %
Description of key information
Dustiness:
Total dustiness (DMT): 32.8 mg/g
MMAD1 = 4.03 µm, GSD1 = 1.10, p1= 15 %
MMAD2 = 100 µm, GSD2 = 9.83, p2 = 85 %
Fractional deposition in human respiratory tract:
Head (ET): 43.00 %
Tracheobronchial (TB): 0.66 %
Pulmonary (PU): 1.79 %
PSD:
Aluminium lanthanum trioxide has the folllowing particle size distribution:
D10: 0.28 µm
D50: 1.0 µm (max < 1.5 µm)
D90: 3.02 µm
D100: 7.8 µm (max < 10.0 µm)
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
