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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 8, 2007 - Dec 13, 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to an internationally recognised method, and under GLP. The substance is adequately characterised. Deviations were reported. The study was conducted according to the approved study protocol with 4 changes In the opinion of the Study Director, the validity of the results was not adversely affected by these changes. The substance is adequately characterised. Therefore full validation applies.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
The study was conducted according to the approved study protocol with 4 changes:
GLP compliance:
yes (incl. QA statement)
Remarks:
See Annex 6 of the full report
Type of method:
column elution method

Test material

Constituent 1
Reference substance name:
NOREENAL
IUPAC Name:
NOREENAL
Test material form:
other: Liquid
Details on test material:
colourless translucent liquid.
The batch number was reported as 862036
It was stored at room temperature protected from direct sun light

Results and discussion

Water solubility
Water solubility:
ca. 34.8 mg/L
Temp.:
21 °C
pH:
>= 7.01 - <= 7.05
Details on results:
Experiment n°1 - 25 mL/h flow rate (See Table 4)
A 1.0060 g sand portion was coated with 167.9 mg of test item (See Protocol deviation n°2). A sample of 0.3202 g was introduced in the micro-column. Analytical assessments of the coated sand showed that the micro-column was thus charged with approximately 25 mg of test item.
About 0.6 mg of the test item was controlled to be voided in the rinsed volume (15 mL).
A total of five successive samples were submitted to the analysis which corresponded to the elution over a 6-hour period. All of them served for the calculation of the hydrosolubility.
Mean concentration in water = 37.4 mg/L with a standard deviation of 2.1 mg/L.
pH of the resulting solution was measured as 7.01.
Experiment n°2 - 13 mL/h flow rate (See Table 5)
The volume of water was renewed in the reservoir and in the micro-column, using the same coated sand as for the first experiment, and the system was allowed to stand for 2 hours. The flow rate was adjusted to 12.5 mL/h. The system was considered as free from any insoluble material, and the system was not rinsed (See Protocol deviation n°3).
A total of five successive samples were submitted to the analysis which corresponded to the elution over a 9-hour period: the first sample was collected after 1 hour of elution, and the last four were collected at 2-hour intervals. All the five samples served for the calculation of the hydrosolubility.
Mean concentration in water = 32.2 mg/L with a standard deviation of 2.1 mg/L.
pH of the resulting solution was measured as 7.05.

The second value did not differ by more than 30 % to the first one and mean hydrosolubility of 34.8 mg/L was considered as valid.

Any other information on results incl. tables

Table : Samples collected from the micro-column at 25 mL/h flow rate – Raw data and calculations

 

Sample n°

Dilution rate

Area

Measured mg/L(1)

mg/L in water(2)

1

1/20

125136.06

4.97

39.8

2

120

120388.67

4.77

38.2

3

1/20

121304.72

4.81

38.5

4

1/20

109159.57

4.31

34.5

5

1/20

114064.16

4.51

36.1

(1)  As measured in the diluted chloroform phase resulting from a 2/5 concentration of the aqueous phase

(2)  Recovery was considered as total

Table :Samples collected from the micro-column at 13 mL/h flow rate – Raw data and calculations

 

Sample n°

Dilution rate

Area

Measured mg/L(1)

mg/L in water(2)

1

1/20

111077.79

4.39

35.1

2

1/20

101305.38

3.98

31.9

3

1/20

101844.19

4.01

32.0

4

1/20

92880.93

3.64

29.1

5

1/20

103179.16

4.08

32.7

(1)As measured in the diluted dichloromethane phase resulting from a 2/5 concentration of the aqueous phase

(2)Recovery was considered as total

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
Mean hydrosolubility 34.8 mg/L
Executive summary:

 

Phytosafe study number

07-42-050-ES

Title

GLP analysis of NOREENAL: hydrosolubility

Test item

NOREENAL

Code A45756, batch n°862036

Test dates

Initiation : November 8, 2007

Completion : December 13, 2007

 

Results

 

Hydrosolubility

micro-column elution method

(EEC A6)

Test at 25 mL/h                               37.4 ± 2.1 mg/L

Test at 13 mL/h                               32.2 ± 2.1 mg/L

Mean hydrosolubility                    34.8 mg/L

Validity criteria were fulfilled: The second measure did not deviate by more than 30 % to the first one