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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 November 2017 - 13 December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
Pregnenolone
EC Number:
205-647-4
EC Name:
Pregnenolone
Cas Number:
145-13-1
Molecular formula:
C21H32O2
IUPAC Name:
3-hydroxypregn-5-en-20-one
Test material form:
solid: particulate/powder
Details on test material:
- Physical appearance: white crystalline powder
- Storage conditions: at room temperature

Results and discussion

Water solubility
Key result
Water solubility:
0.344 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 7.7 - <= 8
Remarks on result:
other: average of two runs
Details on results:
Mean concentration in the water samples (n=10) obtained at the flowrate of 24 mL/h was 0.346 mg/L. CV= 1.3%.
Mean concentration in the water samples (n=10) obtained at the flowrate of 12 mL/h was 0.342 mg/L. CV= 2.1%.
The maximum difference on the mean values at both flow rates was ≤ 30% (i.e. 1.2%). Average of two runs: 0.344 mg/L.

The coefficient of variation (CV) (n=10) was ≤ 30% at both flow rates. It demonstrated that the system was in equilibrium at all flow rates.

Any other information on results incl. tables

Small responses at the retention time of the test item were detected in the chromatograms of the samples from the blank column taken at a flow rate of 12 and 24 mL/h. The maximum contribution to the mean analyzed concentration of the samples was 13 % (24 mL/h) and 17% (12 mL/h). It was considered that it has no significant effect on the results of the test samples.

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Applicant's summary and conclusion

Conclusions:
The water solubility at 20°C was determined to be 0.344 mg/L.
Executive summary:

The water solubility of the substance was determined using the column elution method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840.

Quantification was performed by HPLC. The water solubility was calculated as the average of two runs (24 mL/h and 12 mL/h).

The water solubility at 20°C was determined to be 0.344 mg/L. The pH of the fractions obtained at 12 ml/h and 24 ml/h was 7.7 and 8.0.

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