Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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 is normally supplied in solution and if isolated from water, has large particles in view of hygroscopic nature of the solid.
Particle size analysis suggests low dust.
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 with acceptable restrictions
Justification for type of information:
Company data described in detail.
Methods used large sieve size in view of large particles formed during normal production. Lower sieve sizes were not considered necessary to demonstrate low dustiness.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Apparatus
Sieves of 250 and 63 µm

4.2 Analytical balance.



5. Procedure

5.1 Stack the sieves and place on the top sieve a weigh of the substance or material to be
tested.

5.2 Shake the sieves with a left to right motion for 5 minutes.

5.3 Weigh the material retained on each sieve to 2 decimal places



6. Calculation

6.1 The weight retained on each sieve if expressed as a % of the total initial weight of the substance being tested.


7. Report

7.1 Report each fraction retained by each sieve expressed as % of the total +/-
2 x SD.
GLP compliance:
no
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:

Batch number of test material: A-09-03021
Mass median aerodynamic diameter:
> 250 µm
Key result
Percentile:
D90
Mean:
> 250 µm
Remarks on result:
other: Statistical analysis not applied

Sieve µm

Wt in grams

Mean

SD

2xSD

Variance

250

45.32

 

 

 

 

 

45.89

 

 

 

 

 

46.02

 

 

 

 

 

45.57

 

 

 

 

 

45.68

 

 

 

 

 

45.38

 

 

 

 

 

45.97

 

 

 

 

 

46.05

 

 

 

 

 

45.78

 

 

 

 

 

45.91

45.76

0.26162

0.52324

 

0.06845

63

2.96

 

 

 

 

 

2.55

 

 

 

 

 

2.97

 

 

 

 

 

2.58

 

 

 

 

 

2.63

 

 

 

 

 

2.57

 

 

 

 

 

2.49

 

 

 

 

 

2.51

 

 

 

 

 

2.53

 

 

 

 

 

2.68

2.65

0.17658

0.35316

 

0.03118

< 63

0.48

 

 

 

 

 

0.49

 

 

 

 

 

0.38

 

 

 

 

 

0.47

 

 

 

 

 

0.46

 

 

 

 

 

0.41

 

 

 

 

 

0.39

 

 

 

 

 

0.45

 

 

 

 

 

0.47

 

 

 

 

 

0.39

0.41

0.1039

0.2078

0.0108

 

 

 

 

 

 

Conclusions:
The particle size was found to be > 250 micron. An assessment of the dust content was made on the basis of particles passing through a 63 micron sieve. The amount by weight of particles of less than 63 microns was 0.86 %.

Executive summary:

The particle size was found to be > 250 micron. An assessment of the dust content was made on the basis of particles passing through a 63 micron sieve. The amount by weight of particles of less than 63 microns was 0.86 %.

 

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion