RD 14153

Partition coefficient

Link to relevant study record(s)

Reference

Endpoint:

partition coefficient

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted on 15 March 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

no

Remarks:

This study was not conducted under a specific GLP program, this study was conducted following the principles of GLP by experienced and trained personnel using calibrated standards and instrumentation. Relevant SOPs were followed.

Type of method:

flask method

Partition coefficient type:

octanol-water

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor lot/Batch number: 3434.15
- Expiration date of the lot/batch:
- Purity test date:

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

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

OTHER SPECIFICS:

Analytical method:

high-performance liquid chromatography

Key result

Type:

log Pow

Partition coefficient:

> 0.8 - < 1.4

Temp.:

25 °C

pH:

> 6.2 - < 6.5

Remarks on result:

other: temperature not reproted. Assumed to be room temperature i.e. 25°C

Concentration results of RD14153 in the aqueous and octanol phases are shown in Table 1 and mass balance and ratios are tabulated in Table 2. There appears to be a slight concentration dependency with the higher concentrations of material noted in the smaller liquid volumes.

Table 1: RD14153 concentration summary

Run #	Aqueous phase		Octanol Phase
	Sample size (mL)	Sample concn. (mg/mL)	Sample size (mL)	Sample concn. (mg.mL)
1A	133	0.425	67	3.841
1B	133	0.443	67	3.332
2A	100	0.437	100	2.722
2B	100	0.479	100	3.282
3A	160	0.353	40	7.053
3C	160	0.338	40	8.083

Table 2: Octanol/water ratio for RD14153

Run #	RD14153 Mass Balance		Ratio octanol/water	Log octanol/water
	Added	Dissolved
1A	0.563	0.314	9.0	1.0
1B	0.631	0.282	7.5	0.9
2A	0.515	0.316	6.2	0.8
2B	0.515	0.376	6.8	0.8
3A	0.512	0.339	20.0	1.3
3C	0.513	0.377	23.9	1.4
Mean			12.25	1.02
Std. Devn.			7.66	0.25

 

  The mean log Pow over six determinations is 1.0 ± 0.3.                                                                         

Conclusions:

The RD14153 material under test was analyzed per guidelines as set forth in OECD 107, partition coefficient, shake flask method. The mean log Pow for RD14153 is 1.0.

Executive summary:

Objective:

Determine the octanol – water partition coefficient of a newly developed rheological additive product called RD14153 for registration purposes.

Conclusion: The RD14153 material under test was analyzed per guidelines as set forth in OECD 107, partition coefficient, shake flask method. The mean log Pow for RD14153 is 1.0.

Description of key information

The RD14153 material under test was analyzed per guidelines as set forth in OECD 107, partition coefficient, shake flask method. The mean log Pow for RD14153 is 1.0.

Key value for chemical safety assessment

Log Kow (Log Pow):

1.02