Pentatriacontan-18-one

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The solubility of the test item was determined in non-GLP pre-tests in order to specify the solvents to be used for the AMES-, the DPRA-, the LuSens- and the h-CLAT-test.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentatriacontan-18-one

EC Number:

207-993-1

EC Name:

Pentatriacontan-18-one

Cas Number:

504-53-0

Molecular formula:

C35H70O

IUPAC Name:

pentatriacontan-18-one

Test material form:

solid

Results and discussion

Solubility in organic solvents / fat solubility

Solubility in organic solvents / fat solubility 1

Key result

Medium:

acetonitrile

Remarks on result:

other: not soluble

Solubility in organic solvents / fat solubility 2

Key result

Medium:

DMSO

Remarks on result:

other: The solubility of the test item was determined in non-GLP tests as indicated in the follow-ing table

Solubility in organic solvents / fat solubility 3

Key result

Medium:

acetone

Remarks on result:

other: The solubility of the test item was determined in non-GLP tests as indicated in the follow-ing table

Solubility in organic solvents / fat solubility 4

Key result

Medium:

other: Ethylenglykol

Remarks on result:

other: not soluble

Solubility in organic solvents / fat solubility 5

Key result

Medium:

other: Tetrahydrofuran

Remarks on result:

other: not soluble

Test substance stable:

not determined

Any other information on results incl. tables

Solvent	Final Test Item Concentration	Treatment		Solubility
		Vortex	Sonication	soluble	not soluble
H2O demin.	50 mg/mL	-	-	-	ok
H2O for HPLC	0.6 mg/mL	2 min	1 min	-	ok
Medium RPMI 1640	500 mg/mL	ü	30 min	-	ok
Medium RPMI 1640	100 mg/mL	ü	30 min	-	ok
Medium DMEM	100 mg/mL	ü	30 min	-	ok
Acetonitril/H2O [50%/50%]	0.6 mg/mL	2 min	1 min	-	ok
Acetonitril	0.6 mg/mL	2 min	1 min	-	ok
DMSO/Acetonitril [50%/50%]	0.6 mg/mL	2 min	1 min	-	ok
DMSO/Acetonitril [10%/90%]	0.6 mg/mL	2 min	1 min	-	ok
DMSO	500 mg/mL	ü	30 min	-	ok
DMSO	100 mg/mL	ü	30 min	-	ok
DMSO	50 mg/mL	-	-	-	ok
Ethylenglykol	400 mg/mL	ü	-	-	ok
2-Propanol	0.6 mg/mL	2 min	1 min	-	ok
Aceton	50 mg/mL	-	-	-	ok
Tetrahydrofuran	200 mg/mL	-	-	-	ok
Aceton/Acetonitril [50%/50%]	0.6 mg/mL	2 min	1 min	-	ok

Applicant's summary and conclusion

Conclusions:

The test item Stearone was completely insoluble in any of the tested solvents at any of the tested concentrations

Executive summary:

The test item Stearone was completely insoluble in any of the tested solvents at any of the tested concentrations. Therefore, none of the tests indicated in chapter2can be performed according to the respective guidelines.

Due to these results,in vitrogenotoxicity tests like Chromosomal Aberration Test (OECD 473 and EU B.10), Micronucleus Test (OECD 487 and EU B.49), Cell Gene Mutation Test using theHprtgenes (OECD 476) and Cell Gene Mutation Test using the Thymidine Kinase Gene (OECD 490) also cannot be performed according to the respective guidelines.

Thesolubility ofStearonein water according to OECD 105 resp. EU A.6 was determined in a separate study (17051108G910).