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Physical & Chemical properties

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
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because the stability of the substance is not considered to be critical

Description of key information

According to the Annex IX Standard Information Requirements for REACH, 7.15 of the assessment of the stability in organic solvents and identity of relevant degradation products is “only required if stability of the substance is considered to be critical”.

According to Section R.7.1.6 of the Endpoint Specific Guidance, “There are rare occasions when it is important to have information on the stability of a compound in an organic solvent, to ensure confidence in the test results. However, for many substances, the stability in organic solvents will not be critical and testing need not be conducted”.

For organic peroxides in the maximum market concentrations, there is extensive experience in handling/shipment supporting the stability in the solvents used (or even needed for stabilising reasons). In some cases, approval by authorities is obtained (e.g. statements from German BAM) specifying suitable solvents. In addition, in the context of toxicity studies, analytical data support and confirm the stability of the substance in relevant solvents.

Therefore, the stability in organic solvents is not considered critical and testing is therefore not required. If stability in an organic solvent is deemed critical, it is typically as a medium for another study and determined as a pre-test for the other study and therefore not reported separately.

Additional information

According to the Annex IX Standard Information Requirements for REACH, 7.15 of the assessment of the stability in organic solvents and identity of relevant degradation products is “only required if stability of the substance is considered to be critical”.

According to Section R.7.1.6 of the Endpoint Specific Guidance, “There are rare occasions when it is important to have information on the stability of a compound in an organic solvent, to ensure confidence in the test results. However, for many substances, the stability in organic solvents will not be critical and testing need not be conducted”.

For organic peroxides in the maximum market concentrations, there is extensive experience in handling/shipment supporting the stability in the solvents used (or even needed for stabilising reasons). In some cases, approval by authorities is obtained (e.g. statements from German BAM) specifying suitable solvents. In addition, in the context of toxicity studies, analytical data support and confirm the stability of the substance in relevant solvents.

Therefore, the stability in organic solvents is not considered critical and testing is therefore not required. If stability in an organic solvent is deemed critical, it is typically as a medium for another study and determined as a pre-test for the other study and therefore not reported separately.