Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Partition coefficient

Link to relevant study record(s)

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26.03.2010 - 07.05.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

For the preparation of the stock solution, the test item was dissolved in water saturated in n-octanol instead of n-octanol saturated in water because the test item was more soluble in water than in n-octanol. There is no impact on the study.

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministere de l'Economie, des Finances et de l'Emploi, Paris, France

Type of method:

shake-flask method to: flask method

Partition coefficient type:

octanol-water

Specific details on test material used for the study:

TEST ITEM
Identification PROTEOL OAT
Identification of the flask LCE08118; 500 g
Batch number 0820000006
Expiry date Not provided
Supplier SEPPIC
Appearance Clear yellow limpid viscous liquid
Packaging 1 White plastic flask with blue stopper
Quantity received 1 x 500 g
Date of the reception November 18, 2008
Lot / batch: 820000006
The maximum temperature was recorded daily and was below 30°C during the storage period. The test item was stored away from moisture and direct light. The sample was submitted to the test as received.

Analytical method:

high-performance liquid chromatography

Type:

log Pow

Partition coefficient:

0.51

Temp.:

20.2 °C

pH:

ca. 6.2

Remarks on result:

other: standard deviation of log Pow: ±0.07 log units

Type:

Pow

Partition coefficient:

3.29

Temp.:

20.2 °C

pH:

ca. 6.2

Remarks on result:

other: standard deviation of Pow: ±0.51 log units

Preliminary considerations and estimation:

The test item was found to be very soluble in water (approximately 278 g/L), and only poorly soluble in

n-octanol (approximately 1 g/L) resulting in an estimated partition coefficient of about 4.0E-03 (log Pow

= -2.4). No official method is reported for this domain. However, the “Shake Flask Method” can be

adapted for this determination.

Conclusions:

The value of partition coefficient is Pow=3.29 and Log(Pow)=0.51 at 20.2°C in purified water (pH 6.2) according method EEC A8/OECD 107.

Executive summary:

The n-octanol/water partition coefficient of the test item is Pow=3.29 and Log(Pow)=0.51 at 20.2°C in purified water (pH 6.2) according to the "Shake flask Method".

Description of key information

test material: the liquid marketed product "Proteol OAT" which contains ca.27.5% of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts".

method: EEC A8/OECD 107

temperature: 20.2°C

partition coefficient: Pow=3.29 and Log(Pow)=0.51 in purified water (pH 6.2)

Key value for chemical safety assessment

Log Kow (Log Pow):

0.51

at the temperature of:

20.2 °C

Additional information

The n-octanol/water partition coefficient of the test item is Pow=3.29 and Log(Pow)=0.51 at 20.2°C in purified water (pH 6.2) according to the "Shake flask Method".