Octadecene, reaction products with hexadecene, hydrogenated

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 January 2020 to 16 January 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

OECD Guideline for the Testing of Chemicals – 105 Water solubility (Adopted by the Council on 27th July 1995)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

other: The validated analytical method was used for the determination of the test item content in HPLC water

Specific details on test material used for the study:

No further details specified in the study report.

Key result

Water solubility:

< 0.21 mg/L

Conc. based on:

test mat.

Temp.:

20 °C

pH:

>= 5.2 - <= 5.3

Details on results:

Seven results from the nine aliquots were below LOQ and only in two cases were above values measured. In this two cases microdroplet formation and improper phase separation were supposed (as the test item is a water-like colourless liquid, the visual verification of the phase separation was difficult).
The average of the
The water solubility of the test item is below 0.21 mg/L at 20±0.5°C (

Summary of the calibrations

Analytical occasion	A	B	R^2	Accuracy (%)
				At LOQ	Above LOQ
16 Jan 2020	15.5710	-0.0341	0.9992	102.6	94.6 – 106.8

 

Min – max temperatures during the experiment

Date	Tmin(°C)	Tmax(°C)
12 Jan 2020	29.66
13 Jan 2020	29.43	29.71
14 Jan 2020	29.57	29.81
15 Jan 2020	29.39	29.51
16 Jan 2020	19.57	19.68

 

Results of the solubility measurements

Sample	cTS	cAverage	Difference between days	Solubility	pH
	(mg/L)	(mg/L)	(%)	(mg/L)
TS24h-1	0.349	<LOQ	N/A	<LOQ	5.2
TS24h-2	<LOQ
TS24h-3	<LOQ
TS48h-1	<LOQ	<LOQ	N/A		5.3
TS48h-2	<LOQ
TS48h-3	<LOQ
TS72h-1	<LOQ	<LOQ	N/A		5.2
TS72h-2	<LOQ
TS72h-3	0.296

 

Conclusions:

The water solubility of the test item is below 0.21 mg/L at 20±0.5°C (

Executive summary:

The validated analytical method (FPBSTUDY-206-VAL2-REPORT-01; CRL-VES study code: 19/045-920AN) was used for the determination of the test item content in HPLC water.

 

Results of the method validation in aquatic media

Specificity: Interfering components conform to less than 20% of the LOQ criteria

Repeatability: 3.59% (n=7 injections)

Dynamic range: 0.02 – 0.3 mg/mL

Limit of Quantification: 0.02 mg/mL analytical sample concentration; 0.21 mg/mL sample concentration (counting with 100x enrichment and 1.05x dilution during the sample preparation)

Recovery and Precision at 0.4 mg/L*

Media: HPLC water

Recovery (%): 95.4

Precision (%): 3.4

Stability of the analytical sample (%)

26 g 25 min (%): 99.6

*The indicated concentration is calculated as the test item amount (in the spiking solution) is divided by the volume of the test solution.

 

Seven results from the nine aliquots were below LOQ and only in two cases were above values measured. In this two cases microdroplet formation and improper phase separation were supposed (as the test item is a water-like colourless liquid, the visual verification of the phase separation was difficult).

The average of the <LOQ values is reported.

 

The water solubility of the test item is below 0.21 mg/L at 20 ± 0.5°C (<LOQ).

Description of key information

The water solubility of the test item is below 0.21 mg/L at 20 ± 0.5°C (<LOQ).

 

Key value for chemical safety assessment

Water solubility:

0.21 mg/L

at the temperature of:

20 °C

Additional information

The validated analytical method was used for the determination of the test item content in HPLC water.

Seven results from the nine aliquots were below LOQ and only in two cases were above values measured. In this two cases microdroplet formation and improper phase separation were supposed (as the test item is a water-like colourless liquid, the visual verification of the phase separation was difficult).

 

The water solubility of the test item is below 0.21 mg/L at 20 ± 0.5°C (<LOQ).