1,4-Dioxaspiro[4.5]decane, 8-[4-(4-methylphenyl)-3-cyclohexen-1-yl]-

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2003-10-06 to 2003-12-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

GLP compliance:

yes (incl. QA statement)

Type of method:

column elution method

Key result

Water solubility:

0.006 mg/L

Conc. based on:

test mat.

Temp.:

20 °C

pH:

>= 7.17 - <= 7.24

Time in h	Sample	Appearance	pH-value	Concentration in mg/L
Flow rate 25.0 mL/h
11:30	6	clear	7.19		0.006 mg/L
12:30	7	clear	7.24		0.006 mg/L
13:30	8	clear	7.19		0.005 mg/L
6:30	9	clear	7.17		0.005 mg/L
7:30	10	clear	7.22		0.005 mg/L
Flow rate 12.5 mL/h
11:30	6	clear	7.19		0.006 mg/L
12:30	7	clear	7.21		0.006 mg/L
13:30	8	clear	7.20		0.006 mg/L
6:30	9	clear	7.17		0.005 mg/L
7:30	10	clear	7.20		0.005 mg/L

The mean value and the relative standard deviation were calculated from the 5 individual values of samples 6 to 10. At a flow rate of 25.0 mL / h, the water solubility was 0.005 mg / L (relative SD: ± 10.14 %). At a flow rate of 12.5 mL / h, a water solubility of 0.006 mg / L (relative SD: ± 9.78 %) was determined. Since the repeatability of the values for the water solubility of both flow rates was < 30 %, the overall mean value was formed and reported as the water solubility.

Conclusions:

The water solubility of the test item was determined to be 0.006 mg / L at 20 °C and a pH around 7.2.

Executive summary:

The water solubility was determined according to Regulation 92/69/EWG, method A.6 using the column elution method with HPLC analysis. The columns were loaded with 0.5 g of the test item per 10 g silica gel. Two columns were used with a flow rate of 25 mL / h and 12.5 mL / h, respectively. The water was recirculated for 141 h. The concentrations of 5 consecutive measurements did not differ by more than 30 %. The mean water solubility was determined to be 0.006 mg / L at 20 °C and a pH around 7.2.

Description of key information

The water solubility of the test item was determined to be 0.006 mg / L at 20 °C and a pH around 7.2 (reference 4.8-1).

Key value for chemical safety assessment

Water solubility:

0.006 mg/L

at the temperature of:

20 °C

Additional information

The water solubility was determined according to Regulation 92/69/EWG, method A.6 using the column elution method with HPLC analysis. The columns were loaded with 0.5 g of the test item per 10 g silica gel. Two columns were used with a flow rate of 25 mL / h and 12.5 mL / h, respectively. The water was recirculated for 141 h. The concentrations of 5 consecutive measurements did not differ by more than 30 %. The mean water solubility was determined to be 0.006 mg / L at 20 °C and a pH around 7.2.