Registration Dossier

Administrative data

Endpoint:
surface tension
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because based on structure, surface activity is not expected or cannot be predicted
the study does not need to be conducted because surface activity is not a desired property of the material
the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 August 2017 - 20 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
column elution method
Test material information:
Composition 1
Key result
Water solubility:
< 0.03 mg/L
Conc. based on:
element (dissolved fraction)
Remarks:
Y
Temp.:
20 °C
pH:
6
Remarks on result:
other: Expressed as yttrium content in water; mean at flow rates of 12.5 mL/h and 25 mL/h.
Key result
Water solubility:
< 0.1 mg/L
Conc. based on:
test mat. (dissolved fraction)
Remarks:
Result calculated based on dissolved Y measurements.
Temp.:
20 °C
pH:
6
Remarks on result:
other: Mean at flow rates of 12.5 mL/h and 25 mL/h.
Details on results:
Results were validated by:
- Linearity validation: The analysis showed a good linearity of the method (r > 0.99).
- Accuracy validation: Results in dilution mixture showed a good accuracy which indicates acceptable data (recoveries ranged between 70 and 110%).
- Repeatability validation: The results indicated a good precision of the data (RSD < 20%).
- Specificity: The intensity (CPS) of blank samples measured was negligible.
- Limit of quantification: 0.015 mg Y/L
- Limit of detection: 0.005 mg Y/L

Results of the preliminary test with milliQ water and at pH 6 were:

Amount of test item weighed (g) 0.1 0.1 0.1 0.1 0.1 0.1  0.01
Volume of water added (mL) 0.1 0.5 1 2 10 100 1000
Solubility (yes/no) No No  No  No No  No No (after > 96 h of agitation of the test solution)

Results of the main test:

 

Solubility expressed as

yttrium content in water

(mg/L)

Solubility of yttrium fluoride in water

(mg/L)

Mean pH measured

Temperature

(°C)

Test 1

(flow 25 mL/h)

 < 0.02

 < 0.03

 6

 20

Test 2

(flow 25 mL/h)

 0.03  0.05  6  20
Mean (Test 1 and Test 2)  < 0.03  < 0.05  6  20

Test 3

(flow 12.5 mL/h)

 0.03

 < 0.05

 6

 20

Mean (12.5 mL/h and 25 mL/h)

 < 0.03  < 0.05 rounded at < 0.1  6  20
Conclusions:
The water solubility of yttrium trifluoride was determined to be < 0.1 mg/L at pH 6 and at 20°C. This result was calculated from the measured yttrium content in water which was < 0.03 mg/L (column elution method).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion