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Reference
Endpoint:
relative self-ignition temperature (solids)
Remarks:
Minimum ignition energy of dust clouds (MIE) and the minimum ignition temperature of dust layers (MITdl).
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009.09.05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: EN 50281-2-1 1998: Part 2-1
Version / remarks:
Methods for determining the minimum ignition temperature of dust
Principles of method if other than guideline:
Two micronized products from LEO Pharma A/S were tested at GexCon’s dust explosion test laboratory for the determination of the minimum ignition energy of dust clouds (MIE) and the minimum ignition temperature of dust layers (MITdl).
GLP compliance:
no
Specific details on test material used for the study:
Sodium fusidate
Fusidic acid
Key result
Relative self-ignition temperature:
> 155 °C
Remarks on result:
not determinable
Remarks:
No ignition (105-155 °C) Fusidic acid
Key result
Relative self-ignition temperature:
> 350 °C
Remarks on result:
not determinable
Remarks:
No ignition (200-350 °C) Sodium fusidate

Results for minimum ignition temperature of dust layers, Sodiumfusidate.

 Thickness of dust layer  Hotplate temperature (°C) Time to ignition or timeelapsed without ignition (min)  Max. temperature measured in the sample  (°C)

 Results

 5

 200

 210

 179

 No ignition   

 5

 250

 41

246

 No ignition   

 5*

 300

 132

 295

 No ignition/melted   

 5

 320

80

 310

 Melted   

 5

 350

 105

 335

 Melted   

Results for minimum ignition temperature of dust layers, Fusidic acid

  Thickness of dust layer   Hotplate temperature (°C) Time to ignition or timeelapsed without ignition (min) Max. temperature measured in the sample  (°C)

  Results

 5

 105

 75

 99

  

 No ignition 

 5

 115

 300

 75

  

 No ignition 

 5

125

 65

 130

  

 No ignition 

 5

135 

 126

 133

  

 No ignition 

 5*

 145

 132

 128

  

No ignition/melted

 5*

 155

 55

 157

  

No ignition/melted

*The lowest part of the dust layer (the one that rest on the hotplate) melted. The topmost part of the

dust layer was not melted.

Conclusions:
The test results for the determination of the minimum ignition energy of dust clouds were:
Sodium fusidate: 10 -15 mJ
Fusidic acid: < 2 mJ

Sodium fusidate
Tests were performed with 5 mm layer thicknesses in the temperature ranges of 200°C - 350°C. No ignition was observed

Fusidic acid
Tests were performed with 5 mm layer thicknesses in the temperature ranges 105°C - 155°C. No ignition was observed
Executive summary:

The samples were tested in the open Hartmann apparatus for the determination of the minimum ignition energy of dust clouds.

The samples were tested using the so-called Hot Plate for the determination of the minimum ignition

temperature of dust layers. In both cases the samples were tested under atmospheric conditions.

The test results for the determination of the minimum ignition energy of dust clouds were:

Sodium fusidate: 10 -15 mJ

Fusidic acid: < 2 mJ

Results from determining the minimum ignition temperature of dust layers were

Sodium fusidate

Tests were performed with 5 mm layer thicknesses in the temperature ranges of 200°C - 350°C. No ignition was observed

Fusidic acid

Tests were performed with 5 mm layer thicknesses in the temperature ranges 105°C - 155°C. No ignition was observed

Description of key information

The samples were tested in the open Hartmann apparatus for the determination of the minimum ignition energy of dust clouds.

The samples were tested using the so-called Hot Plate for the determination of the minimum ignition

temperature of dust layers. In both cases the samples were tested under atmospheric conditions.

The test results for the determination of the minimum ignition energy of dust clouds were:

Sodium fusidate: 10 -15 mJ

Fusidic acid: < 2 mJ

Results from determining the minimum ignition temperature of dust layers were

Sodium fusidate

Tests were performed with 5 mm layer thicknesses in the temperature ranges of 200°C - 350°C. No ignition was observed

Fusidic acid

Tests were performed with 5 mm layer thicknesses in the temperature ranges 105°C - 155°C. No ignition was observed

Key value for chemical safety assessment

Additional information