Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

Principles of method if other than guideline:

Statement of consulting Laboratory Huntingdon Life Sciences Ltd.: TGD version 4.3.2 final draft, Chapter 2, 3.5 states that temperature dependence is only required “if relevant”. It is our opinion that DMPAP is a highly water-soluble substance and will still be highly water-soluble at 10ºC and 30ºC. Therefore further investigation of this parameter is considered to be unnecessary. Deviations from test method A6 are often required for substances of high solubility.
For example, the use of five-fold excess of test substance produces an over-saturated solution. In cases of substances of high solubility this simply results in a thick suspension or sludge which is often intractable or difficult to separate. Also, the time taken and method employed to separate the phases can affect the solubility result.
Pre-equilibration at 30ºC is not recommended for substances of high solubility it simply induces instant crystallisation and solidification of the test substance to produce an intractable mass on cooling to the test temperature of 20ºC.
Analysis of test substance over different time periods is not required as a limit value of solubility was determined.

GLP compliance:

yes

Type of method:

flask method

Remarks:

Modified

Key result

Water solubility:

> 100 g/L

Conc. based on:

test mat.

Temp.:

20 °C

pH:

>= 5 - <= 9

Remarks on result:

completely miscible

Details on results:

The substance was found to be completely miscible with water at all proportions at room temperaturein the pH range 5 - 9.

Conclusions:

The substance was found to be completely miscible with water at all proportions at room temperature. The test substance is completely soluble in water in the pH range 5 - 9.

Executive summary:

The study was performed in year 2002 in accordance with the Directive 92/69/EEC, Method A6 (flask method) and OECD Guideline No. 105. The substance was found to be completely miscible with water at all proportions at room temperature. The test substance is completely soluble in water in the pH range 5 - 9.

Description of key information

The test substance is completely soluble in water in the pH range 5 - 9 at room temperature.

Key value for chemical safety assessment

Water solubility:

100 g/L

at the temperature of:

20 °C

Additional information

The substance was found to be completely miscible with water at all proportions at room temperature. The test substance is completely soluble in water in the pH range 5 - 9. Whilst no water solubility value is available for this substance, the maximum value of 100 g/L has been selected as the key value for the chemical safety assessment.