Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to an internationally recognised method. No deviation was reported. Test substance is adequately specified. Therefore full validation applies.

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)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
not specified
GLP compliance:
no
Type of method:
flask method

Test material

Constituent 1
Reference substance name:
Almond, sweet, ext.
EC Number:
291-063-5
EC Name:
Almond, sweet, ext.
Cas Number:
90320-37-9
IUPAC Name:
Proteins from sweet almond extract
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: white powder
- Storage: in a dark place at room temperature
- Batch : 16 187
- Manufacturing date: July 5th 2016
- Expiry date: July 5th 2018

Results and discussion

Water solubility
Key result
Water solubility:
ca. 350 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
520 g/L
Temp.:
30 °C
pH:
ca. 8

Applicant's summary and conclusion

Conclusions:
A non-GLP study using flask method according to OECD method 105 and EU. A.6. was conducted to determine the water solubility of the test item.
The water solubility of the test item was determined as 350 g/L at 30 )C ± 0.5°C (pH=8).
The conditions of the test were:
- loading rate of 520 ± 1 g/L
- a water content of 6.0% w/w of POLYLIFT AT (dry matter result obtained on the powder).
Executive summary:

A non-GLP study using flask method according to OECD method 105 and EU. A.6. was conducted to determine the water solubility of the test item.

The water solubility of the test item was determined as 350 g/L at 30 °C ± 0.5°C (pH=8).

The conditions of the test were:

-       loading rate of 520 g/L ± 1 g/L

-       a water content of 6.0% w/w of POLYLIFT AT (dry matter result obtained on the powder).