oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Partition coefficient

Link to relevant study record(s)

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan - May 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 107 (Partition Coefficient (n-octanol / water), Shake Flask Method)

Qualifier:

according to guideline

Guideline:

OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)

GLP compliance:

yes (incl. QA statement)

Type of method:

estimation method (solubility ratio)

Partition coefficient type:

octanol-water

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 4G08
- Purity, including information on contaminants, isomers, etc.: approx 95% no further information

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature at about 20 °C in dry conditions
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: not stated but assumed stable
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not stated but assumed stable
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: no solvent/ vehicle used
- Reactivity of the test material with the incubation material used (e.g. plastic ware): no reactivity assumed

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
no treatment

FORM AS APPLIED IN THE TEST (if different from that of starting material)
same as received

Analytical method:

high-performance liquid chromatography

Key result

Type:

log Pow

Partition coefficient:

< -5.2

Temp.:

20 °C

Remarks on result:

other: Temperatur assumed

Conclusions:

The partition coefficient, log Pow, of MG-60 was calculated from the individual solubiliteis in n-octanol and in water, respectively, to be: log Pow = log10 (< 0.004 /636) < -5.2

Executive summary:

Neither the HPLC-method according to OECD 117 nor the flask-shaking method according to OECD Guideline No. 107 were applicable for the determination of the partition coefficient of MG-60. Thus, the log Pow-value for the test item was estimated from its solubility in n-octanol and in water respectively.

The partition coefficient, log Pow, of MG-60 was calculated from the individual solubiliteis in n-octanol and in water, respectively, to be: log Pow = log10 (< 0.004 /636) < -5.2

In the present study, the n-Octanol solubility of MG-60 was determined to be < 4.011 µg/ml, which is below the concentration of the smallest calibration point (multiplied with the dilurtion factor). The tabulated values represent rounded results, which were obtained by calculation using the exact raw data. A calibration curve was determined. The correlation coefficient r2 was 0.9898. This reflects the linearity of the HPLC system within the calibration range of 1.6045 to 128.36 mg/l of the test item.

Key value for chemical safety assessment

Log Kow (Log Pow):

-5.2

at the temperature of:

20 °C