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Physical & Chemical properties

Solubility in organic solvents / fat solubility

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Reference
Endpoint:
solubility in organic solvents / fat solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 October 2015 - 21 October 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Indication of solubility in propylene glycol based on experiments in view of the development and validation of an analytical method for the analysis of the test item in propylene glycol.
Qualifier:
no guideline followed
Principles of method if other than guideline:
For the development and validation of an analytical method for analysis of the test item in propylene glycol, the following guideline was followed: EC guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex VII (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414, SANCO/3029/99 rev. 4 (11/07/00). No specific guidelines were followed for determination of the solubility of the test item in propylene glycol.
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch: M14KB4863
Stable under storage conditions until 10 November 2017 (retest date)
Storage conditions: at room temperature
Key result
Medium:
other: propylene glycol
Solubility:
>= 207 g/L
Test substance stable:
yes
Details on results:
Analysis of formulations at 1 mg/mL (low) and 200 mg/mL (high) after storage yielded a relative difference of <= 10%. Based on this, the formulations were found to be stable during storage at room temperature under normal laboratory light conditions for at least 6 hours.
Conclusions:
Based on experiments performed in view of the development and validation of an analytical method for the test item in propylene glycol, the solubility of the test item in propylene glycol can be concluded to be >= 207 g/L. The test item proved to be stable in propylene glycol during storage at room temperature under normal laboratory light conditions for at least 6 hours.

Description of key information

Based on experiments performed in view of the development and validation of an analytical method for the test item in propylene glycol, the solubility of the test item in propylene glycol can be concluded to be >= 207 g/L. The test item proved to be stable in propylene glycol during storage at room temperature under normal laboratory light conditions for at least 6 hours (Brekelmans, 2016).

Key value for chemical safety assessment

Additional information

In view of the preparation of dose formulations for toxicity testing, trial preparations were prepared using a series of vehicles. As soon as a suitable vehicle is found, no further trial preparations are prepared. Propylene glycol was found to be a suitable vehicle, however, it was also reported that the substance did not dissolve in a 1% aqueous carboxymethyl cellulose solution (see study report of Latour (2016) on acute dermal toxicity testing). Next to this solution and propylene glycol, no other solvents were tested.