L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 March 2020 to 14 July 2020

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Version / remarks:

1995

Deviations:

yes

Remarks:

A range of sample concentrations were prepared for visual assessment

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Version / remarks:

2008

Deviations:

yes

Remarks:

A range of sample concentrations were prepared for visual assessment

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of Inspection: 21 August 2018; Date of Issue: 19 November 2018

Type of method:

flask method

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark

Key result

Remarks on result:

completely miscible

Details on results:

Although the 95% w/w sample had areas that had different descriptions, because there was no residual water present (test item adsorbed the water) the test item has been classified as fully miscible. The reason the sample was not uniform in appearance was considered to be due to the extremely viscous nature of the test item. This meant the water was absorbed rather than mixed. As further confirmation, the sample was heated up to approximately 80°C and the sample became a straw coloured viscous liquid with no residual water but on cooling back to room temperature white opaque areas reappeared.

The sample concentrations, observations and solution pH are shown in the following table.

 

Table 2

Sample	Concentration (% w/w)	Observations	Solution pH
1	5.42	Clear, colourless liquid. No visible excess test item present	6.2
2	25.0	Pale straw coloured liquid. No visible excess test item present	6.1
3	50.6	Straw coloured liquid. No visible excess test item present.	6.1
4	75.9	Straw coloured slightly viscous liquid. No visible excess test item present	5.9
5	95.0	Extremely viscous liquid. Comprises of clear straw coloured areas and white opaque areas. No residual water remaining.	n/a

Conclusions:

The test item has been determined to be miscible with water in all proportions at 20.0 ± 0.5°C

Executive summary:

The test item was determined to be miscible with water in all proportions at 20.0 ± 0.5 °C, using a modified flask method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995

Description of key information

Miscible with water in all proportions at 20.0 ± 0.5°C; OECD 105; Fox, J. M. (2020)

Additional information

A value for water solubility cannot be reported as the test item was determined to be completely miscible with water at the test temperature at 5 nominal loading rates.