Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Aug - 01 Sep 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted in 1995
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sotrage conditions: Store in a dark storage place at room temperature.

Results and discussion

Water solubility
Water solubility:
ca. 353 mg/L
Conc. based on:
test mat. (dissolved fraction)
Temp.:
20 °C
pH:
ca. 5.9

Any other information on results incl. tables

Results

Table 1 – Measurement results

Sample

pH

Test item concentration in test solution - measured value [mg/L]

Average [mg/L]

Standard deviation

Maximum difference (%)

Sample 1-a

6.0

354

353

2.40

1.90

Sample 1-b

6.0

357

Sample 2-a

5.9

352

Sample 2-b

5.9

354

Sample 3-a

5.9

352

Sample 3-b

5.8

350

 

The water solubility of the test item is 353 mg/L (20 °C).

Discussion
The maximum difference of test item concentration among the test solutions in each test water was within 15%. Therefore, it is concluded that the test results are acceptable

Applicant's summary and conclusion