Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2017
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:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
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: white powder
- Storage: in a dark place at room temperature
- Batch : 15 262
- Manufacturing date: September 14th, 2015
- Expiry date: September 14th, 2018

Results and discussion

Water solubility
Key result
Water solubility:
ca. 348 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
501 g/L
Temp.:
32 °C
pH:
ca. 4

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 was determined as 348.0 g/L at 32 ± 0.5°C (pH=4).
The conditions of the test were:
- loading rate of 501 ± 1 g/L
- a water content of 8.4% w/w in the 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 the test item.

The water solubility was determined as 348.0 g/L at 32 ± 0.5°C (pH=4).

The conditions of the test were:

- loading rate of 501 ± 1 g/L

- a water content of 8.4% w/w in the test item (dry matter result obtained on the powder).