oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

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.6 (Water Solubility)

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

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

Key result

Water solubility:

> 636 g/L

Conc. based on:

test mat.

Incubation duration:

24 h

Temp.:

20 °C

Remarks on result:

other: Temperature assumed

Conclusions:

The water solubility of MG-60 was found to be > 636 g/l at room temperature

Executive summary:

The determination of the water solubility of MG-60 was perforrmed according to the EEC Directive 92/69, A.6 "Water Solubility" (1992) and the OECD Guideline No. 105 "Water Solubility" (1995) using a simplified flask method.

After mixing a total of about 5.2 g of test imet in 5 ml of water the test item was completely dissolved. thus, the test item is miscible with water. The determination of the concentration in the above mentioned test item/water mixture was confirmed by HPLC with respect to a calibration curve.

A main test using the flask shaking method was not possible as no saturated solution of test item in water can be prepared.

The calibration data for test item-standars were used to produce a calibration curve. The r2 fit was 0.9978. This reflects the linearity of the HPLC-system within the calibration range of 6.418 to 128.36 mg/l of the test item.

The water solubility of MG-60 was found to be > 636 g/l at room temperature

Key value for chemical safety assessment

Water solubility:

636 g/L

at the temperature of:

20 °C