Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 2018 to 01 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

GLP compliance:

yes

Type of method:

flask method

Specific details on test material used for the study:

The surface tension of the test material was determined by OECD Test No. 115. It was concluded: The mean surface tension of duplicate saturated solutions of test material in water (1 g/L saturated solution diluted to 90%) has been determined to be 29.8 mN/m at 20.0 ± 0.5 °C. The test material was considered to be surface-active.

Key result

Remarks on result:

not determinable

Remarks:

Direct measurement of the water solubility by OECD Test No. 105 could not be done due to surfactant properties of the test material.

Details on results:

PRELIMINARY TEST
- At 10 g/L the test material solution was cloudy, had residual solids, and exhibited surface foaming.
- At 1 g/L the test material solution was cloudy, initially had residual solids and exhibited surface foaming. After 6 hours the residual solids had suspended but the solution still exhibited surface foaming and remained cloudy. It did not clarify by filtration (0.2 μm) and the properties remained the same after 24 hours.
- Observations: No chemical instability was observed during the test. Surfactant properties were observed.

CONCLUSIONS AND REQUEST FOR EXEMPTION
- The test material exhibits surfactant qualities (foaming, stable cloudy solution). Direct measurement of the water solubility by OECD Test No. 105 could not be done due to surfactant properties of the test material. This is consistent with the surface tension data provided by the Sponsor, after the OECD 105 testing was attempted.

Conclusions:

The test material exhibits surfactant qualities (foaming, stable cloudy solution). Direct measurement of the water solubility by OECD Test No. 105 could not be performed due to surfactant properties of the test material. This is consistent with the surface tension data provided by the Sponsor, after the OECD 105 testing was attempted.

Executive summary:

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions.

The preliminary test was only conducted at the 10 and 1 g/L levels. A 0.1 g sample was weighed into a 100 mL graduated cylinder and 10 mL of water was added and mixed. The test material was not soluble so the water volume was brought to 100 mL and it was mixed.

At 10 g/L the test material solution was cloudy, had residual solids, and exhibited surface foaming. At 1 g/L the test material solution was cloudy, initially had residual solids and exhibited surface foaming. After 6 hours the residual solids had suspended but the solution still exhibited surface foaming and remained cloudy. It did not clarify by filtration (0.2 μm) and the properties remained the same after 24 hours. No chemical instability was observed during the test. Surfactant properties were observed.

The Definitive Test was not performed given the observations in the Preliminary Test.

Under the conditions of the test, the test material exhibited surfactant qualities (foaming, stable cloudy solution) meaning direct measurement of water solubility could not be performed.

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Description of key information

Direct measurement of the water solubility by OECD Test No. 105 could not be performed due to surfactant properties of the test material. This is consistent with the surface tension data provided by the Sponsor, after the OECD 105 testing was attempted.

Additional information

The water solubility of the test material was investigated in accordance with the standardised guideline OECD 105, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The preliminary test was only conducted at the 10 and 1 g/L levels. A 0.1 g sample was weighed into a 100 mL graduated cylinder and 10 mL of water was added and mixed. The test material was not soluble so the water volume was brought to 100 mL and it was mixed.

At 10 g/L the test material solution was cloudy, had residual solids, and exhibited surface foaming. At 1 g/L the test material solution was cloudy, initially had residual solids and exhibited surface foaming. After 6 hours the residual solids had suspended but the solution still exhibited surface foaming and remained cloudy. It did not clarify by filtration (0.2 μm) and the properties remained the same after 24 hours. No chemical instability was observed during the test. Surfactant properties were observed.

The Definitive Test was not performed given the observations in the Preliminary Test.

Under the conditions of the test, the test material exhibited surfactant qualities (foaming, stable cloudy solution) meaning direct measurement of water solubility could not be performed.