Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

The MMAD of the worst-case commercial granular presentations of the product lies between 46.0 and 52.1 μm, well above the fraction known as respirable, that may reach the lower respiratory tract. Although a maximum of 5.14% of the substance in the granular solid corresponds to particles with a diameter below 10 μm, the absorption of antimony from respiratory tract is a function of particle size. Aerosols containing small particles composed of antimony compounds with low water solubility (e.g., particles of antimony oxides) are retained in the lungs for a longer period of time than those containing larger particles with hight water solubility (particles of antimony tartrate). Therefore, in vivo inhalation test is not considered.

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:

30/09/2011

Reliability:

2 (reliable with restrictions)

Principles of method if other than guideline:

The samples were examined by laser diffraction in order to determine the Mass median aerodynamic diameter (MMAD); this is also known as the geometric mean aerodynamic diameter.
The analysis was carried out using the Coulter LS230 Laser Diffraction Particle Size Analyser fitted with the Dry Powder Module. The analysis was carried out 5 times. 3 of the 5 runs were then averaged to produce the results in the table below.
Optical Model: The calculation of particle size requires optical values of the material for increased accuracy; for this work we used a refractive index of 1.645 (determined by immersing the material in refractive index matching oils) and an imaginary component of 0.0.

Type of method:

Laser scattering/diffraction

Type of distribution:

mass based distribution

Specific details on test material used for the study:

The test has been carried out on the substance itself (Antimony Potassium Tartrate).

Mass median aerodynamic diameter:

>= 46 - <= 52.1 µm

Geometric standard deviation:

>= 0.9 - <= 254.54

Key result

Percentile:

D50

Mean:

>= 46 - <= 52.1 µm

St. dev.:

254.54

Conclusions:

The laser diffraction tests performed to conduct particle size distribution studies on two batchess originating from different producers of the substance Antimony Potassium Tartrate, indicate a mass median aerodynamic diameter of 46.0 - 52.1 micrometers. A maximum of 5.14% of the particles have a diameter below 10 micrometers, corresponding to the respirable fraction.

Data source

Reference

Reference Type:

review article or handbook

Title:

Antimony Toxicity

Author:

Shyam Sundar and Jaya Chakravarty

Year:

2010

Bibliographic source:

Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005