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Stability in organic solvents and identity of relevant degradation products

Link to relevant study record(s)

Reference

Endpoint:

stability in organic solvents and identity of relevant degradation products

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-03-11 / 2009-07-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

It is GLP but no test guideline is available

Qualifier:

no guideline available

Principles of method if other than guideline:

The test substance was dissolved in the solvent, and concentration measured at 0, 24 and 72 hours.

GLP compliance:

yes (incl. QA statement)

Test substance stable:

yes

Transformation products:

no

Data of the Performance of the Stability in organic solvents

Age	Sample	Nominal concentration of test item	Measured concentration of test item	Measured concentration of test item	Measured concentration of test item	Sample preparation factor	Determined average concentration of test item	Recovery rate	Means
(h)	ID	cnom (mg/L)	Sample 1 (mg/L)	Sample 2 (mg/L)	Average (mg/L)	F	c (mg/L)	R (%)	R(%)
Test	item	solution	in	Acetone
0	SA5	1.04	1.11	1.04	1.08	1	1.08	103
	SA6	1.06	1.15	1.17	1.16	1	1.16	110	107
24	SA3	1.05	1.09	1.18	1.14	1	1.14	109
	SA4	1.04	1.15	1.07	1.11	1	1.11	107	108
72	SA1	1.06	1.07	1.06	1.06	1	1.06	100
	SA2	1.07	1.14	1.12	1.13	1	1.13	105	103
Test	Item	Solution	in	Methanol
0	SM5	1.04	1.09	1.13	1.11	1	1.11	107
	SM6	1.06	1.15	1.02	1.09	1	1.09	103	105
24	SM3	1.06	1.16	1.14	1.15	1	1.15	108
	SM4	1.04	1.14	1.15	1.15	1	1.15	111	109
72	SM1	1.05	1.09	1.11	1.10	1	1.10	105
	SM2	1.04	1.07	1.09	1.08	1	1.08	104	105
Test	Item	Solution	in	n-Octanol
0	SO5	1.06	0.935	0.971	0.953	1	0.953	90
	SO6	1.05	0.970	0.957	0.964	1	0.964	92	91
24	SO3	1.05	0.887	0.882	0.884	1	0.884	84
	SO4	1.03	1.04	0.942	0.992	1	0.992	96	90
72	SO1	1.05	1.08	1.05	1.07	1	1.07	102
	SO2	1.04	1.02	1.04	1.03	1	1.03	99	100

Conclusions:

No hint for a degradation of the test item within 72 hours at 20ºC in Acetone, Methanol or n-Octanol could be found.

Executive summary:

The objective of this study was to determine the stability of the substance in different organic solvents and to identify possible degradation products.

The solvents used were Acetone, Methanol and n-Octanol. No hint for a degradation in the solvents tested was found within the chosen storage conditions (72 hours, 20ºC), based on measured concentration of test item.

Description of key information

No hint for a degradation of the test item within 72 hours at 20ºC in Acetone, Methanol or n-Octanol could be found.

Additional information

A reliable stability study was conducted, with measurement of the test substance in three solvents before and after storage.