Acetic acid, esters with lanolin alcs.

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 January 2018 - 02 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25/03/10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

no

Type of method:

flask method

Water solubility:

0.14 mg/L

Temp.:

20 °C

pH:

ca. 7

Remarks on result:

other: The pH and temperature are not specified.

Details on results:

Water solubility was, as expected, low., falling within the range 0.1 and 0.4 mg/l expected for lanolin alcohols.

Conclusions:

Interpretation of results (migrated information): other: Slightly soluble (< 0.40 mg/l)
The water solubility of the test material has been determined to be 0.14 mg/l of solution at room temperature.

Executive summary:

Method

The determination was carried out using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.

Conclusion

The water solubility of the test material has been determined to be 0.14 mg/l at room temperature.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7840 (Water Solubility)

Deviations:

no

GLP compliance:

yes

Type of method:

column elution method

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, esters with lanolin alcs.

EC Number:

262-980-8

EC Name:

Acetic acid, esters with lanolin alcs.

Cas Number:

61788-49-6

Molecular formula:

C29H48O2

IUPAC Name:

Acetic acid, esters with lanolin alcs.

Test material form:

liquid

Results and discussion

Water solubility

Water solubility 1

Key result

Water solubility:

< 1.2 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

500 µg/L

Incubation duration:

12 h

Temp.:

19.6 °C

pH:

7.9

Water solubility 2

Key result

Water solubility:

< 1.2 mg/L

Conc. based on:

test mat.

Loading of aqueous phase:

500 µg/L

Incubation duration:

12 h

Temp.:

19.6 °C

pH:

7.7

Any other information on results incl. tables

Table 1 -Water Solubility of the Test Item
Flow Rate (mL/h)	Sample No.	Individual [mg/L]	Mean(1,3) [mg/L]	CV[%]	Mean(2,3) [mg/L]	MD [%]	pH
24	1	<1.20	<1.20	n.a	<1.20	n.a	7.9
24	2	<1.20					7.9
24	3	<1.20					7.9
24	4	<1.20					7.9
24	5	<1.20					7.9
24	6	<1.20					7.9
24	7	<1.20					7.9
24	8	<1.20					7.9
24	9	<1.20					7.9
24	10	<1.20					7.9
12	1	<1.20	<1.20	n.a			7.7
12	2	0.19 (4)					7.7
12	3	<1.20					7.7
12	4	<1.20					7.7
12	5	<1.20					7.7
12	6	0.091 (4)					7.7
12	7	<1.20					7.7
12	8	<1.20					7.7
12	9	<1.20					7.7
12	10	<1.20					7.7
1)Mean of the concentrations obtained at one flow rate.   2) Mean of the concentrations obtained at both flow rates.   3)Mean of the concentrations was below the lowest calibration standard, taking the dilution factor of 2 into account. 4) Obtained by extrapolation of the calibration curve. n.a. Not applicable

Applicant's summary and conclusion

Conclusions:

The water solubility of the test item at 20°C was <1.20 mg/L. The pH of the aqueous samples was 7.9 and 7.7.

Executive summary:

The results for the samples taken at a flow rate set to 12 and 24 mL/h are given in Table 1. No test item was detected at either flow rate.  The analyzed concentrations are therefore reported to be below the lowest calibration standard, multiplied by the dilution factor. The turbidity of the eluates was not < 0.2 NTU but < 0.3 NTU.  These values were accepted and according to this, no undissolved particles were detected in the eluates. No test item was detected in the samples from the blank column. Since no test item was detected in the fraction collected from the column, column material was analyzed to demonstrate that the carrier material still contained test item after elution with water. Test item was detected in the column material, which confirmed that the correct test item was used in the study.   The water solubility of the test item at 20°C was <1.20 mg/L. The pH of the aqueous samples was 7.9 and 7.7.