Nicotine

Water solubility

Link to relevant study record(s)

Reference

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-11-05 to 2014-11-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with standard test protocols (OECD 105 resp. EU A.6) in a quality controlled laboratory. The study is valid according to criteria mentioned in the test protocols.

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

yes

Remarks:

see "principles of method if other than guideline"

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

yes

Remarks:

see "principles of method if other than guideline"

Principles of method if other than guideline:

As the test item nicotine is very well soluble in water, it was not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main study as described in the guidelines.

GLP compliance:

yes (incl. QA statement)

Type of method:

other: simplified flask method without analytical determination

Water solubility:

other: miscible with water in all proportions

Temp.:

20 °C

pH:

>= 8 - <= 10

Remarks on result:

other: The test item nicotine gives an alkaline solution when mixed with water.

Details on results:

In none of the solutions the Tyndall effect was visible (i.e. a laser beam was not scattered when transmitted through the liquid). The test item had dissolved completely in all cases (visual judgement).

Observations during the evaluation of the water solubility of nicotine at room temperature:

Test Item [g]	H2O [mL]	Appearance	Test Item [g]	H2O [mL]	Appearance
1	0.1	clear liquid, no Tyndall effect	10	0.1	clear liquid, no Tyndall effect
1	1	clear liquid, no Tyndall effect	10	1	clear liquid, no Tyndall effect
1	2	clear liquid, no Tyndall effect	10	2	clear liquid, no Tyndall effect
1	5	clear liquid, no Tyndall effect	10	5	clear liquid, no Tyndall effect
1	10	clear liquid, no Tyndall effect	10	10	clear liquid, no Tyndall effect

Conclusions:

Interpretation of results (migrated information): miscible in all proportions

Executive summary:

The determination of the water solubility of nicotine was performed by a simplified flask method without analytical determination. 

After mixing 1 g and 10 g of the test item, respectively, with 0.1 mL, 1 mL, 2 mL, 5 mL, and 10 mL of H₂O at room temperature, the test item nicotine was completely dissolved (visual judgement).

The results of the test indicated that nicotine is miscible with water in all proportions. Thus, it is not possible to weigh the fivefold saturation concentration of the test item in water in order to perform a main study. The main study as described in the guidelines is therefore not necessary in this case.

In conclusion, nicotine was considered to be miscible with water in all proportions at room temperature, and no further testing was performed.

Description of key information

Study was conducted in a quality controlled laboratory. The results are reliable without restriction. Key study is appropriate for the risk assessment.

Key value for chemical safety assessment

Water solubility:

100 000 mg/L

at the temperature of:

20 °C