Registration Dossier
Registration Dossier
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EC number: 223-578-8 | CAS number: 3965-55-7
Stability in organic solvents and identity of relevant degradation products
Administrative data
Link to relevant study record(s)
Description of key information
The stability in organic solvents is not regarded as critical. In addition the test item was found to be stable in Dimethylsulfoxide and 1,2-Propandiol up to 72 h at 23 °C.
Additional information
Justification for adaptation according to REACH Annex IX
According to the Annex IX Standard Information Requirements of Regulation (EC) No 1907/2006 (REACH), 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 (2012), “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”.
Thus, the determination of the stability in organic solvents (required in section 7.15) was waived as the stability of the test substance is not an essential property and in addition the experience in handling and use shows the test item is stable in organic solvents.
Stability in Dimethylsulfoxide
A solution of the test substance in DMSO was prepared and stored for 72 h at room temperature (23 °C) without stirring. After the time intervals aliquots of the solution were diluted 1/100 with acetonitrile/water = 60/40 (v/v) and the test substance concentration was determined by HPLC analysis. The recovery rate after 72 h was determined to be 99 % at concentration of 2.885 g/L Thus, the test substance was found to be stable in DMSO during a period of 72 h.
Stability in 1,2-Propanediol
A solution of the test substance in 1,2-Propanediol was prepared and stored for 72 h at room temperature (23 °C) without stirring. After the time intervals aliquots of the solution were diluted 1/100 with acetonitrile/water = 60/40 (v/v) and the test substance concentration was determined by HPLC analysis. The recovery rate after 72 h was determined to be 101 % at concentration of 2.988 g/L Thus, the test substance was found to be stable in 1,2-Propanediol during a period of 72 h.
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