Yucca schidigera, ext.

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-reference

Cross-reference 1

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.

Cross-reference 2

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.

Cross-reference 3

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

Test material information

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