Registration Dossier

Administrative data

Endpoint:
partition coefficient
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 5, 2014 - May 21, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with EC A.8, OECD 107 and EPA OPPTS 830.7550.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.8 (Partition Coefficient)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)
Version / remarks:
(1995)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7550 (Partition Coefficient, n-octanol / H2O, Shake Flask Method)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes
Type of method:
shake-flask method to: flask method
Partition coefficient type:
octanol-water

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Strontium Tartrate (anhydrous)
- Appearance: Off-white powder

Study design

Analytical method:
other: ICP-MS (see IUCLID Section 8)

Results and discussion

Partition coefficientopen allclose all
Type:
Pow
Partition coefficient:
< 0
Temp.:
20 °C
pH:
7
Remarks on result:
other: Mean value (n=6). Standard deviation: 0.000068
Type:
log Pow
Partition coefficient:
< -3.6
Temp.:
20 °C
pH:
7
Remarks on result:
other: Mean value (n=6)
Details on results:
- Preliminary test: the content of test substance dissolved in the n-octanol sample was 0.00035 g/L
- Main study: the log Pow values fell within the criterion range of ± 0.3 log units (see table below)

- The mean analysed concentration of the substance in the stock solution was 0.822 g/L. Based on this, the nominal quantity of the test substance in each test vessel was 1.64 mg. The recoveries were determined according to this value.
- The quantity analysed in each of the test vessels was in the range of 1.55 and 1.66 mg; the recoveries were thus between 94 and 101%.

Any other information on results incl. tables

Shake-flask method results

Ratio
n-octanol : water
[v:v]

Analysed concentration

Pow

log Pow

pH

n-octanol
[g/L]

water
[g/L]

individual

mean

 

 

 

 

 

 

 

1:1

<6.42E-05

0.277

<2.3 x 10-4

<2.4 x 10-4

< -3.6

7.0

 

<6.39E-05

0.267

<2.4 x 10-4

 

< -3.6

7.0

 

 

 

 

 

 

 

1:2

<6.40E-05

0.204

<3.1 x 10-4

<3.1 x 10-4

< -3.5

7.0

 

<6.40E-05

0.203

<3.2 x 10-4

 

< -3.5

7.1

 

 

 

 

 

 

 

2:1

<6.31E-05

0.393

<1.6 x 10-4

<1.6 x 10-4

< -3.8

7.0

 

<6.38E-05

0.387

<1.7 x 10-4

 

< -3.8

7.0

 

 

 

 

 

 

 

No test substance was detected in the pre-treated samples from the blank mixture. Therefore no correction was applied on the results.

 

Applicant's summary and conclusion

Conclusions:
In a GLP-compliant study in accordance with EC A.8, OECD 107 and EPA OPPTS 830.7550 using the shake-flask method, the log Pow of the substance at pH 7 and 20°C was determined as < -3.6 (Pow: < 0.00024).