Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-02-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
tap density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-02-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Tap density was determined
GLP compliance:
not specified
Other quality assurance:
other: not specified
Type of method:
pour and tap (for solids)
Key result
Type:
tap density
Remarks:
mean value
Density:
0.44 g/cm³
Temp.:
20 °C

Table: Results, Tap density at 20°C

Determination

Weight (g)

Volume (ml)

Tap Density (g/ml)

1

40.03

91

0.44

2

40.04

91

0.44

3

40.00

91

0.44

Mean Value

0.44

Conclusions:
The study was performed scientifically reasonable, documentation is sufficient. Hence, the results can be considered as reliable.
Executive summary:

The tap density of Yucca schidigera, ext. was determined in three repetions as 0.44 g/ml at 20°C.

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019-02-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
A defined amount of test item was weighed into a defined amount of water, the undissolved material was determined.
GLP compliance:
not specified
Other quality assurance:
other: not specified
Type of method:
other: determination of undissolved material
Key result
Water solubility:
200 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
200 g/L
Incubation duration:
> 10 - < 15 min
Temp.:
20 °C
Remarks on result:
other: pH value not stated, presumably pH ca. 4
Conclusions:
The study was performed scientifically reasonable, documentation is sufficient. Hence, the results can be considered as reliable.
Executive summary:

The water solubility of Yucca schidigera, ext. was determined to be 20% at 20°C.

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
pH
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2019-02-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
The pH value of two aqueous solutions of the test item was determined via pH-meter.
GLP compliance:
not specified
Other quality assurance:
other: not specified
Reagent:
water
pH value:
4.4
Temp.:
20 °C
Concentration:
10 g/L
pH value:
4.3
Temp.:
20 °C
Concentration:
100 g/L
Executive summary:

The pH values of a 1% resp. 10% aqueous solution of Yucca schidigera, ext. were determined via pH meter to 4.4 resp. 4.3 at 20°C.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test item was sieved with defined sieves and weighed.
GLP compliance:
not specified
Other quality assurance:
other: not specified
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution

Test material

Constituent 1
Reference substance name:
Yucca schidigera, ext.
EC Number:
607-033-5
Cas Number:
223749-05-1
IUPAC Name:
Yucca schidigera, ext.
Test material form:
solid
Details on test material:
Structural Formula: not applicable, UVCB substance

Results and discussion

Mass median aerodynamic diameter:
> 0.08 - < 0.125 mm
Particle size
Key result
Percentile:
D99
Mean:
> 0.08 mm
Remarks on result:
other: St. dev. not available

Applicant's summary and conclusion

Conclusions:
The study was performed scientifically reasonable, documentation is sufficient. Hence, the results can be considered as reliable.
Executive summary:

The particle size distribution of Yucca schidigera, ext. was determined by sieving as follows:

Sieve

Weight of the residue of the sieve (g)

rx Residue on the sieve (%)

> 3.0 mm

3.4

3.4

< 3.0 mm > 2.0 mm

1.8

1.8

< 2.0 mm > 1.0 mm

3.2

3.2

< 1.0 mm > 0.6 mm

1.2

1.2

< 0.6 mm > 0.3 mm

3.2

3.2

< 0.3 mm > 0.212 mm

0.2

0.2

< 0.212 mm > 0.125 mm

2.0

2.0

< 0.125 mm > 0.08 mm

2.0

2.0

< 0.08 mm

83.0

83.0