Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.12.2013 to 10.01.2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Siemens AG, Prozess-Sicherheit, Industriepark Höchst, B 596 & B 598, D-65926 Frankfurt am Main, Germany
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-Ku, Tokyo 1048315, Japan/Batch No.: 130808
- Expiration date of the lot/batch: 07.08.2016
- Purity test date: 24.09.2013

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (10-30°C)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:no

FORM AS APPLIED IN THE TEST (if different from that of starting material): solid

Results and discussion

Water solubility
Key result
Water solubility:
311 g/L
Conc. based on:
test mat. (dissolved fraction)
Loading of aqueous phase:
452 g/L
Incubation duration:
<= 72 h
Temp.:
20 °C
pH:
9

Applicant's summary and conclusion

Conclusions:
The water solubility was determined to be 311 g/L at 20°C.
Executive summary:

The water solubility of acylglycinate GCK-12H -T (dry matter) was investigated in a study conducted according EU Method A.6 (Water Solubility) and OECD Guideline 105 (Water Solubility) and using the flask-method. The water solubility determined via HPLC measurements was found to be 311 g/L at 20°C. The recovery experiments with standard solutions indicated a sufficient accuracy of the analytical method.