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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Mass median aerodynamic diameter:
ca. 308 µm
Geometric standard deviation:
>= 2.82 - <= 2.92
Percentile:
D10
Mean:
66 µm
St. dev.:
0.97
Key result
Percentile:
D50
Mean:
267 µm
St. dev.:
6.3
Percentile:
D90
Mean:
1 426 µm
St. dev.:
4.6

Average (µm)

Volume weighted mean: 578.7 µm

Median (D50): 267.0 µm

Mode: 1206 µm

MMAD (Mass Median Aerodynamic Diameter): 308.0 µm

10 % of material is 66.4 µm

50 % of material is 267.0 µm

90 % of material is 1426 µm

1.87 % by volume of sample was seen to be <10 µm

Conclusions:
In conclusion, it can be stated that a manual sieve analysis indicated that 99.1% by weight of the sample had a particle size of <2000 µm. A subsequent laser diffraction analysis on the <2000 µm sample revealed that the median (d50) was 267 µm.
Executive summary:

In summary, the laser diffraction test conducted to determine the Particle size analysis produced the following results: Manual sieve analysis indicated that 99.1% by weight of the sampe had a particle size of <2000 µm. A subsequent laser diffraction analysis on the <2000 µm sample revealed that the median size (d50) was 267 µm and that the mass median aerodynamic diameter (MMAD) was 308 µm.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Endpoint:
particle size distribution (granulometry)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Mass median aerodynamic diameter:
ca. 262 µm
Geometric standard deviation:
>= 2.97 - <= 3.07
Percentile:
D10
Mean:
49 µm
St. dev.:
0.94
Key result
Percentile:
D50
Mean:
229 µm
St. dev.:
2.56
Percentile:
D90
Mean:
622 µm
St. dev.:
7.92

Average (µm)

Volume weighted mean: 288 µm

Median (D50): 229 µm

Mode: 472 µm

MMAD (Mass Median Aerodynamic Diameter): 262 µm

10 % of material is 49 µm

50 % of material is 229 µm

90 % of material is 622 µm

2.67 % by volume of sample was <10 µm

Conclusions:
A manual sieve analysis indicated that 95.6% by weight of the sample had a particle size of < 2000 µm. A subsequent laser diffraction analysis on the < 2000 µm sample revealed that the median size (d50) was 229 µm.
Executive summary:

In summary, the laser diffraction test conducted to determine the particle size distribution produced the following results: Manual sieve analysis indicated that 95.6% by weight of the sampe had a particle size of < 2000 µm. A subsequent laser diffraction analysis on the < 2000 µm sample revealed that the median size (D50) was 229 µm and that the mass median aerodynamic diameter (MMAD) was 262 µm.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Description of key information

For L- and D-lactide, the MMAD were 308 and 262 µm, the median size (d50) was 267 and 229 µm. There is no reason why the particle size distribution of dilactide would differ from that of L- or D-lactide, as dilactide is a mixture of D-and L-lactide isomers. 
    
    
    
    

ers.

Additional information

There is no reason why the particle size distribution of dilactide would differ from that of L- or D-lactide. D- and L-lactide are suitable read across partner as dilactide is a mixture of D- and L-lactide isomers.