Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 May 2017 to 13 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
GLP compliance:
yes
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Appearance: Yellow crystalline powder
Test item storage: At room temperature
Stable under storage conditions until: 01 February 2018 (expiry date)

Results and discussion

Water solubility
Key result
Water solubility:
< 0.05 mg/L
Conc. based on:
test mat.
Temp.:
19.7 °C
pH:
6.4
Details on results:
preliminary test: 1.74 mg/L (loading 191 mg/L at 20.4± 0.5°C (stirred at 300 rpm for 22 h)

A small peak was observed at the retention time of the test item. It was considered to derive from contamination since a similar response was observed in the analytical blank. The water solubility was determined to be below the lowest calibration curve. The analysed concentrations are therefore reported to be below the lowest calibration standard.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
No test item was detected in the samples from the blank column

Any other information on results incl. tables

Flow rate

[mL/h]

Sample no.

Concentration analyzed

pH

Individual
[mg/L]

Mean1
[mg/L]

CV
[%]

Mean2
[mg/L]

MD
[%]

 

 

 

 

 

 

 

 

 

24

1

n.a.3

n.a.4

n.a.

n.a.4

n.a.

6.4

 

2

n.a.3

 

 

 

 

 

 

3

n.a.3

 

 

 

 

 

 

4

n.a.3

 

 

 

 

 

 

5

n.a.3

 

 

 

 

 

 

6

n.a.3

 

 

 

 

 

 

7

n.a.3

 

 

 

 

 

 

8

n.a.3

 

 

 

 

 

 

9

n.a.3

 

 

 

 

 

 

10

n.a.3

 

 

 

 

 

 

 

 

 

 

 

 

 

12

1

n.a.3

n.a.4

n.a.

 

 

6.4

 

2

n.a.3

 

 

 

 

 

 

3

n.a.3

 

 

 

 

 

 

4

n.a.3

 

 

 

 

 

 

5

n.a.3

 

 

 

 

 

 

6

n.a.3

 

 

 

 

 

 

7

n.a.3

 

 

 

 

 

 

8

n.a.3

 

 

 

 

 

 

9

n.a.3

 

 

 

 

 

 

10

n.a.3

 

 

 

 

 

 

 

 

 

 

 

 

 

1    Mean of the concentrations obtained at one flow rate.

2    Mean of the concentrations obtained at both flow rates.

3     A small peak was observed at the retention time of the test item. It was considered to derive from contamination since a similar response was observed in the analytical blank.

4     Mean of the concentrations was below the lowest calibration standard of 0.00500 mg/L.

n.a.Not applicable.

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance is < 0.05 mg/L
Executive summary:

Using the column elution method the water solubility of the substance was below the limit of quantification of the analytical method (<0.05 mg/L).