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Stability in organic solvents and identity of relevant degradation products

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Reference
Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: 98/8/EC IIIA, III 2
Deviations:
no
GLP compliance:
yes
Test substance stable:
yes
Transformation products:
not measured
Conclusions:
The test material is stable as a nominal 10 g/l solution in Diethyl Ether for at least 32 days at 25 ± 2 °C. The test material undergoes an approximately 10 % reduction in concentration during the first 14 days of storage at 25 ± 2 °C as a 10 g/l solution in Tetrahydrofuran with no further significant change in concentration for the next 18 days of storage at 25 ± 2 °C. As the results indicate that the test material reached a stable concentration during the storage period, the approximate 10% reduction is not regarded as significant.
Executive summary:

The stability of the test material has been determined in two organic solvents in accordance with Council Directive 98/8/EC, Annex III. The test material is stable as a nominal 10 g/l solution in Diethyl Ether for at least 32 days at 25 ± 2 °C.

The test material undergoes an approximately 10 % reduction in concentration during the first 14 days of storage at 25 ± 2 °C as a 10 g/l solution in Tetrahydrofuran with no further significant change in concentration for the next 18 days of storage at 25 ± 2 °C. As the results indicate that the test material reached a stable concentration during the storage period, the approximately 10 % reduction is not regarded as significant.

Description of key information

Stability in organic solvents: Results indicate that the test material reached  a stable concentration during the storage period.

Additional information

The stability of the test material has been determined in two organic solvents in accordance with Council Directive 98/8/EC, Annex III. The test material is stable as a nominal 10 g/L solution in Diethyl Ether for at least 32 days at 25 ± 2 °C.

The test material undergoes an approximately 10 % reduction in concentration during the first 14 days of storage at 25 ± 2 °C as a 10 g/l solution in Tetrahydrofuran with no further significant change in concentration for the next 18 days of storage at 25 ± 2 °C. As the results indicate that the test material reached a stable concentration during the storage period, the approximately 10 % reduction is not regarded as significant.