Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-04-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The water solubility of the test substance was determed by stepwise addition of the test substance into water and visual inspection.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C4-Amine
- Substance type: Mono constituent substance

Results and discussion

Details on results:
The water solubility of test substance was determined to be ≥ 66.7 wt%.

Any other information on results incl. tables

Table 1. Step by step addition of test substance into 10 g water

Step

amount of test substance added (g)

total amount added (g)

Concentration

(wt%)

visual observation

Temperature rise

1

1

1

9.1%

clear, colorless solution

from 22 to 24

2

2

3

23.1%

clear, colorless solution

from 23 to 26

3

4

7

41.2%

clear, colorless solution

from 25 to 32

4

13

20

66.7%

clear, colorless solution

from 31 to 45

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): miscible
The water solubility of test substance was determined to be ≥ 66.7 wt%.
Executive summary:

The water solubility of the test substance was determined by stepwise addition of the test substance into water and visual inspection. An amount of 1, 2, 4, and 13 g of test substance was added into the same Erlenmeyer-flask containing 10g water in

each step. The total amounts of the test substance after each addition were 1, 3, 7, and 20 g. A clear, colorless solution was obtained after each addition. The water solubility of test substance was determined to be ≥ 66.7 wt%.

This study did not follow a guideline nor conducted under GLP. However, the test procedure meets generally accepted scientific principles and is acceptable for assessment.