Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to 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:
OECD Guideline 105 (Water Solubility)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
not specified
GLP compliance:
no
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 16 208
- Manufacturing date: July 26th 2016
- Expiry date: July 26th 2018

Results and discussion

Water solubility
Key result
Water solubility:
ca. 716.1 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
2 368 g/L
Temp.:
30 °C
pH:
ca. 6
Remarks on result:
other: The water solubility of NUTRIPEPTIDES® AT was determined as 716.1 g/L at 30 ± 0.5°C (pH=6). The conditions of the test were: - loading rate of 2368 ± 9 g/L - a water content of 7.0% w/w of Nutripeptides® AT (dry matter result obtained on the powder).

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 test item was determined as 716.1 g/L at 30 ± 0.5°C (pH=6).
The conditions of the test were:
- loading rate of 2368 ± 9 g/L
- a water content of 7.0% w/w of test item (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 test item.

The water solubility of test item was determined as 716.1 g/L at 30 ± 0.5°C (pH=6).

The conditions of the test were:

-      loading rate of 2368 ± 9 g/L

-      a water content of 7.0% w/w of test item (dry matter result obtained on the powder).