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Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted 15 September 2016 to 23 May 2017.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Remarks:
UK Department of Health, inspected 13 December 2016 certificate issued 15 March 2017
Type of method:
other: turbidimetry

Test material

Constituent 1
Reference substance name:
Fatty acids, vegetable-oil, polymd., unreacted fraction
EC Number:
273-100-7
EC Name:
Fatty acids, vegetable-oil, polymd., unreacted fraction
Cas Number:
68937-92-8
Molecular formula:
Substance is a UVCB - no structural or molecular formula is available.
IUPAC Name:
5-[(5E)-icos-5-enoyloxy]icosanoic acid
Specific details on test material used for the study:
Identity: RM1004951
Appearance: Clear yellow to amber liquid
Storage conditions: Room temperature (15 to 25°C)
Batch number: 1367Q13601
Purity: 100%
Expiry date: 17 September 2017
Date received: 05 October 2015

Results and discussion

Water solubility
Key result
Water solubility:
ca. 0.1 mg/L
Temp.:
20 °C
pH:
>= 5.9 - <= 6.8
Details on results:
The water solubility of RM1004951 was determined by turbidimetry to be 0.1 mg/L (mean of 0.1 and 0.1 mg/L) (Tables 3 and 4, Figures 2 and 3).

Any other information on results incl. tables

Table 3: Run 1

 Sample Concentration   Turbitdity measurements (NTU) 1   Turbitdity measurements (NTU) 2   Turbitdity measurements (NTU) 3   Turbitdity measurements (NTU) mean  pH  ln Concentration  ln Turbidity

1

 24.83  139.3  142.8  140.1  140.7  6.2  3.212  4.947
 2  12.42  72.2  73.9  72.8  73.0  6.0  2.519  4.290
 3  6.208  37.4  37.4  37.3  37.4  6.0  1.826  3.621
 4  3.104  18.2  18.6  17.8  18.2  6.1  1.133  2.901
 5  1.552  9.82  9.26  9.54  9.54  6.0  0.4395  2.255
6   0.7759  6.28  6.27  6.35  6.30  6.2  -0.2537  1.841
 7  0.3880  2.96  2.97  3.11  3.01  6.0  -0.9467  1.103
 8  0.1940  2.15  2.15  2.06  2.12  6.0  -1.640  0.7514
 9  0.09699  1.69  1.86  1.60  1.72  6.0  -2.333  0.5404
 10  0.04850  1.11  1.11  1.02  1.08  6.0  -3.026  0.07696
11   0.02425  1.48  1.06  1.04  1.19  6.0  -3.719  0.1768
 12  0.01212  1.02  1.05  1.08  1.05  6.0  -4.413  0.04879
 13  0.006062  1.09  1.09  1.04  1.07  6.0  -5.106  0.07077
 14  0.003031  1.04  1.03  1.04  1.07  6.0  -5.799  0.03601
 15  0.001516  1.09  0.98  0.94  1.00  6.1  -6.492  0.003328
 16  0.0007578  0.90  1.03  1.09  1.01  6.0  -7.185  0.00645

Linear regression of points 1 to 9: Linear regression of points 10 to 16:

y = 0.8256x + 2.1093 y1 = 0.0294x + 0.2100

When y = y1, x = ln CMC

CMC = 0.083 mg/L

Table 4: Run 2

Sample Concentration   Turbitdity measurements (NTU) 1   Turbitdity measurements (NTU) 2   Turbitdity measurements (NTU) 3   Turbitdity measurements (NTU) mean  pH  ln Concentration  ln Turbidity
 1 25.05  190.4  192.3  190.4  191.0  6.8  3.221  5.252
 2  12.53  96.3  98.4  97.7  97.5  6.7  2.528  4.580
 3  6.263  48.5  49.2  50.1  49.3  6.6  1.825  3.897
 4  3.131  25.0  24.9  25.7  25.2  6.6  1.141  3.227
 5  1.566  13.6  13.8  13.8  13.7  6.6  0.4485  2.620
6   0.7828  7.24  6.69  7.15  7.03  6.4  -0.2449  1.950
 7  0.3914  3.47  3.97  3.88  3.77  6.2  -0.9380  1.328
 8  0.1957  2.15  2.02  2.11  2.09  6.2  -1.631  0.7388
 9  0.09785  1.24  1.11  1.56  1.30  6.2  -2.324  0.2649
 10  0.04893  0.96  1.48  1.23  1.22  6.1  -3.017  0.2016
11   0.02446  0.36  0.89  0.89  0.71  6.1  -3.711 -0.3378 
 12  0.01223  0.67  0.66  0.66  0.66  6.2  -4.404  -0.4105
 13  0.006116  0.66  0.87  0.69  0.74  6.1  -5.097  -0.3011
 14  0.003058  0.84  0.76  0.74  0.78  6.1  -5.790  -0.2485
 15  0.001529  0.67  0.82  0.84  0.78  6.0  -6.483  -0.2527
 16  0.0007645  0.81  0.82  0.84  0.82  5.9  -7.176  -0.1944

Linear regression of points 1 to 9: Linear regression of points 10 to 16:

y = 0.9110x + 2.2424 y1 = 0.0441x + 0.0043

When y = y1, x = ln CMC

CMC = 0.076 mg/L

Applicant's summary and conclusion

Conclusions:
The water solubility of the substance was determined by turbidimetry to be 0.1 mg/L.
Executive summary:

The water solubility of the substance was determined by turbidimetry to be 0.1 mg/L.