Triglycerides, C16 and C18 (unsaturated)

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

other: turbidimetry

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 151124012
- Expiration date of the lot/batch: 01 March 2020
- Purity test date: Not reported

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None

Water solubility:

4.6 mg/L

Conc. based on:

test mat.

Temp.:

20 °C

pH:

>= 4.5 - <= 8.1

Remarks on result:

other: See 'Remarks'

Remarks:

The mean water solubility from sample A and B.

TABLE 1 - Water solubility measurements (Sample A)

Point	Concentration (mg/L)	Mean turbidity (NTU)	pH	ln concentration	ln turbidity
1	849.9	127	5.1	6.75	4.85
2	425.0	63.8	5.2	6.05	4.16
3	212.5	33.6	5.3	5.36	3.52
4	106.2	16.4	4.5	4.67	2.80
5	53.12	8.65	5.3	3.97	2.16
6	26.56	4.73	5.7	3.28	1.55
7	13.28	2.62	5.9	2.59	0.96
8	6.640	1.40	5.6	1.89	0.34
9	3.320	0.759	5.8	1.20	-0.28
10	1.660	0.552	7.0	0.51	-0.59
11	0.8300	0.470	5.6	-0.19	-0.76
12	0.4150	0.283	5.4	-0.88	-1.26

Linear regression of points 1 to 9, y = 0.921x - 1.43

Linear regression of points 10 to 12, y’ = 0.481x’ - 0.781

Calculated water solubility = 4.38 mg/L

TABLE 2 - Water solubility measurements (Sample B)

Point	Concentration (mg/L)	Mean turbidity (NTU)	pH	ln concentration	ln turbidity
1	832.3	108	5.2	6.72	4.69
2	416.1	54.9	5.3	6.03	4.01
3	208.1	29.4	5.5	5.34	3.38
4	104.0	15.5	5.6	4.64	2.74
5	52.02	7.58	5.7	3.95	2.03
6	26.01	5.27	5.7	3.26	1.66
7	13.00	3.52	5.7	2.56	1.26
8	6.502	1.41	5.8	1.87	0.34
9	3.251	0.878	5.7	1.18	-0.13
10	1.626	0.732	5.4	0.49	-0.31
11	0.8128	0.611	8.1	-0.21	-0.49
12	0.4064	0.294	8.0	-0.90	-1.23

Linear regression of points 1 to 8, y = 0.859x - 1.18

Linear regression of points 9 to 12, y’ = 0.500x’ - 0.610

Calculated water solubility = 4.90 mg/L

Conclusions:

The water solubility of triglycerides, C16 and C18 (unsaturated) is 4.6 mg/L at 20°C.

Executive summary:

A study to determine water solubility of the test item, triglycerides, C16 and C18 (unsaturated), was conducted according to OECD 105 and EC A.6 guidelines. Based on results of the preliminary test, the turbidimetric method was selected for the determination of water solubility of the test item. The test was conducted in duplicate in a temperature controlled room at 20°C.

The water solubility at 20°C was determined to be 4.6 mg/L.

The study was conducted according to standard guidelines and is GLP-compliant and therefore is considered as reliable without restrictions.

Description of key information

The water solubility of the test item at 20°C is 4.6 mg/L.

Key value for chemical safety assessment

Water solubility:

4.6 mg/L

at the temperature of:

20 °C

Additional information

A study to determine water solubility of triglycerides, C16 and C18 (unsaturated) was conducted according to OECD 105 and EC A.6 guidelines using turbidimetric method (Dunning 2019).

The study is a GLP compliant, guideline experimental study and is fully acceptable for assessment of this endpoint.