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

Solubility in organic solvents / fat solubility

Link to relevant study record(s)

Reference

Endpoint:

solubility in organic solvents / fat 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:

other: Method A6 (modified flask method)

Deviations:

no

Principles of method if other than guideline:

Solubility was determined up to 250,000 mg/l – this is a commonly accepted limit value to define a substance as highly soluble, e.g. Council Directive 94/37/EC Concerning Placing of Plant Protection Products on the Market, page 69, para 2.7.
Annex V, Method A6 is for the determination of the solubility of substances in water. It is the experience in this laboratory (Huntingdon Life Sciences Ltd.) that this method is generally unsuitable for the determination of substances of high solubility in organic solvents.
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.
NOTE: Test method A6 is unsuitable for highly soluble substances; simple visual estimation is preferable and more likely to give an accurate answer than using A6 with the inherent problems described above. It is also worth noting that method A6 is wholly inappropriate for totally miscible substances where miscibility can only be proven by incremental addition and observation.

GLP compliance:

yes

Key result

Medium:

ethanol

Solubility:

> 250 g/L

Temp.:

20 °C

Key result

Medium:

n-octanol

Solubility:

> 250 g/L

Temp.:

20 °C

Test substance stable:

yes

Details on results:

No data

Conclusions:

The study was carried out in accordance with Directive 98/8/EC and Directive 92/69/EEC, Method A.6. A known weight of test substance was shaken with increasing volumes of solvent in a stepwise manner and dissolution was assessed visually. The solubility of Bardap 26 AS is greater than 250 g/l in both ethanediol and octanol. No further testing was required.

Executive summary:

The study was carried out in accordance with Directive 98/8/EC and Directive 92/69/EEC, Method A.6. A known weight of test substance was shaken with increasing volumes of solvent in a stepwise manner and dissolution was assessed visually. The solubility of Bardap 26 AS is greater than 250 g/l in both ethanediol and octanol. No further testing was required.

Description of key information

The solubility of Bardap 26 AS is greater than 250 g/l in both ethanediol and octanol. 

Key value for chemical safety assessment

Solubility in organic solvents at 20°C:

250 g/L

Additional information

The solubility of Bardap 26 AS is greater than 250 g/l in both ethanediol and octanol. No further testing was required.