Aluminate(2-),[[N,N'-1,2-ethanediylbis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON] (oxidoborate-µ-oxido)(-1),disodium

Partition coefficient

Administrative data

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02/06/2015 - 05/06/2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method A.8 (Partition Coefficient - Shake Flask Method)

Version / remarks:

Preliminary test

GLP compliance:

yes (incl. QA statement)

Type of method:

estimation method (solubility ratio)

Partition coefficient type:

octanol-water

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 040802#

Study design

Analytical method:

other: the preliminary test result showed that no complementary test was possible (HPLC method cannot be used)

Results and discussion

Partition coefficient

Key result

Type:

log Pow

Partition coefficient:

ca. -4.9

Remarks on result:

other: estimated value because the test item remained undissolved into octanol up to the concentration limit

Any other information on results incl. tables

Estimation of partition coefficient

solvent  Mass of sample (mg)  solvent volume (ml)  estimated solubility (g/l)  Log P  Analysis method  water  5004  6.022  830.95     -4.9     Shake flask method  octanol  0.38  38  0.01

Octanol Sample Preparation Approximately 2 mg of X330 was added to a 40 mL clear glass vial, followed by Octanol 40 mL. The sample was shaken, sonicated and warmed to approximately 40°C. The sample remained undissolved. The preparation above was repeated using 0.40 mg of X330. The second X330 sample remained undissolved. At concentrations below 10 mg/L it was difficult to accurately determine the presence X330. Therefore it is not known if the sample is soluble below this concentration or if this is the limit of detection for the visualisation of X330 in octanol.

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Applicant's summary and conclusion

Conclusions:

The estimated partition coefficient Log Pow = -4.9.

Executive summary:

The partition coefficient was estimated using the shake flask method according to the EU A.8 test guideline. The estimated value was: Log Pow = -4.9