1-Octanamine, N,N-dimethyl-, N-oxide

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1st, 2007 - July 09th, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Specific details on test material used for the study:

- Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.

Key result

Temp.:

20 °C

Remarks on result:

completely miscible

Observations, concentrations and pH's relating to the samples are shown in the following table:   

Sample	Concentration (% w/w)	Observations	pH
1	5.02	Single phase; clear, colourless non-viscous solution	6.7
2	49.8	Single phase; clear, pale yellow coloured, slightly viscous solution	7.7
3	94.4	Single phase; slightly translucent, viscous gel.	*

* Not measured due to extremely viscous nature of the test material

Conclusions:

The test material was determined to be miscible with water in all proportions at 20.0 ± 0.5°C.

Executive summary:

The water solubility of the test material was measured in a GLP-compliant study performed in accordance with EU Method A.6, using the flask method. The test material was determined to be miscible with water in all proportions at 20.0 ± 0.5°C.

Description of key information

The water solubility of the test material was measured in a GLP-compliant study performed in accordance with EU Method A.6, using the flask method. The test material was determined to be miscible with water in all proportions at 20.0 ± 0.5°C.

Additional information

The water solubility of the test material was determined in a GLP-compliant study performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and was selected as key study for the endpoint.