Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 9th - April 21st 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method

Test material

1
Chemical structure
Reference substance name:
4-(2-hydroxyethyl)benzene-1,2-diol
EC Number:
600-704-3
Cas Number:
10597-60-1
Molecular formula:
C8H10O3
IUPAC Name:
4-(2-hydroxyethyl)benzene-1,2-diol
Specific details on test material used for the study:
Batch 17092019

Manufacturing date September 17th, 2019

Expiry date September 17th, 2020

Storage 5+3°C protected from light

Receiving number IP-LV-2020050-AEC

Receiving date February 19°", 2020
#ID LV-MAT-IJE2-20-052-0B14:a

Results and discussion

Water solubility
Key result
Water solubility:
> 10 g/cm³
Conc. based on:
test mat.
Temp.:
20 °C
Remarks on result:
not determinable
Details on results:
The water solubility of test item “HYDROXYTYROSOL’ was performed according to “OECD 105”
The test item seemsto be soluble in water in any proportion with an aqueous solubility at 20°C higher than 10 g/mL.

Any other information on results incl. tables

pH measurements

















 Sample 1Sample 2Sample 3
Average pH (20°C)2.242.222.20

Applicant's summary and conclusion

Conclusions:
The aim of the study was to estimate the water solubility of test item “HYDROXYTYROSOL’ according to OECD 105. The water solubility of a substance is the saturation mass concentration of the substance in water at a given temperature. The determination must be conducted on essentially pure substances which are stable in water and notvolatile.

Before determining water solubility, a preliminary test was performed. It allows to determine
approximately the appropriate amount of sample to be used in the final test, as well as the time
necessary to achieve saturation. The preliminary test proved that the amount of active substance
dissolved was more than 1000 g/L and subsequently the flask method can be used in this study.
The preliminary test showed a solubility higher than 1000 g/L, so three very concentrated solutions (~10 g/mL) werev carried out in order to achieve saturation.
The test was performed with pre-incubation at 30°C and all the solid dissolved. Then the vials with the test solution were incubated at 20°C and no precipitation of solid occurred.
The test item seems to be soluble in water in any proportion with an aqueous solubility at 20°C higher than 10 g/mL.
No method validation was necessary, because there was no saturation of the solutions.