Distilled acetalization product between glucose and C12, C14, C18, C20 ,C22 alcohol

Stability in organic solvents and identity of relevant degradation products

Administrative data

Endpoint:

stability in organic solvents and identity of relevant degradation products

Adequacy of study:

weight of evidence

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Applicant's summary and conclusion

Conclusions:

In accordance with column 1 of REACH Annex IX, the study is only required if stability of the substance is considered to be critical.Considering REACH Annex IX 7.15 criteria, the stability in organic solvents and the identity of relevant degradation products should be assessed. According to the composition of this UVCB, to the literature and to the SEPPIC’s knowledge, the substance “Acetalization products between glucose and C16/18 alcohol” could be reasonably considered as stable in a wide range of organic solvents. By stable, we mean no chemical degradation of any of components of the substance. The substance is perfectly stable in aprotic solvent such as dimethylformamide, dimethylsulfoxide, ether, alkane and organochloride. In solvents such alcohols, a reaction could theoretically occur at high temperature ( > 110°C) with an acidic catalyst which could lead to a modification of the composition of the substance by forming short chain corresponding alkyl glucosides. However, in standard condition, neither degradation nor modifications were observed. To the best of our knowledge, there is no experimental account about any degradation of the substance in any solvents. That is why we thought there is no need to make the aforementioned test performed. This test does not need to be proposed. the stability in organic solvent is not critical.

Executive summary:

In accordance with column 1 of REACH Annex IX, the study is only required if stability of the substance is considered to be critical. Considering REACH Annex IX 7.15 criteria, the stability in organic solvents and the identity of relevant degradation products should be assessed. According to the composition of this UVCB, to the literature and to the SEPPIC’s knowledge, the substance “Acetalization products between glucose and C16/18 alcohol” could be reasonably considered as stable in a wide range of organic solvents. By stable, we mean no chemical degradation of any of components of the substance. The substance is perfectly stable in aprotic solvent such as dimethylformamide, dimethylsulfoxide, ether, alkane and organochloride. In solvents such alcohols, a reaction could theoretically occur at high temperature ( > 110°C) with an acidic catalyst which could lead to a modification of the composition of the substance by forming short chain corresponding alkyl glucosides. However, in standard condition, neither degradation nor modifications were observed. To the best of our knowledge, there is no experimental account about any degradation of the substance in any solvents. That is why we thought there is no need to make the aforementioned test performed. This test does not need to be proposed. the stability in organic solvent is not critical.