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EC number: 941-167-8
CAS number: 1584709-99-8
study was performed similar to OECD Guideline No. 111. The aim of the
study is to assess the stability of the substance in a series of simple
media simulating perfumery applications. The test media are standard
aqueous buffers at pH 2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of
non ionic surfactant (Arkopal N 150). The tests are done in accelerated
conditions at 40 °C during 3 days.
– 300 ppm of raw material are dissolved in the pH buffer containing the
surfactant (Arkopal N 150) and put into storage in an oven at 40°C.
Small aliquots of the test solution are extracted with an organic
solvent (typically cyclohexane or ethyl acetate) containing a
hydrocarbon standard (typically C12, C17 or C20) on a regular basis
throughout the test (typically at time = 0, 0.25, 1, 2, 4, 7, 15, 21 and
28 days). The extracts are analyzed by GC-FID and the results are
plotted as (Area/Area Std) expressed in [%]. The measurement at time = 0
is set at 100% and the succeeding measurements are calculated relatively
to the time = 0 measurement. Therefore the curves represent the
percentage of product remaining in the test solution at the time of
disappearance of the parent compound after 3 days at 40 °C is 32.57% at
pH 2, less than 20% (comprised between 14 and 19%) at pH 5, 7 and 8.5,
and 100% disappearance at pH 12. It can be concluded that under the
conditions of the present test, test substance is not considered
hydrolytically stable at environmentally relevant pH.
assess the hydrolysis potential of the registered substance, a non-GLP
stability test was performed on this substance with a method similar to
OECD Guideline No. 111. This is a standard company internal data conducted
for global knowledge. The test media are standard aqueous buffers at pH
2, pH 5, pH 7, pH 8.5 and pH 12 containing 1% of non ionic surfactant
(Arkopal N 150). The test is done in accelerated conditions at 40 °C
during 3 days.
The disappearance of the parent compound after 3 days at 40°C is 32.57%
at pH 2, less than 20% (comprised between 14 and 19%) at pH 5, 7 and
8.5, and 100% disappearance at pH 12. Therefore, it can be concluded
that under the conditions of the present test, the registered substance
is not considered hydrolytically stable at environmentally relevant pH. However,
as the registered substance is readily biodegradable, a GLP hydrolysis
study does not need to be conducted, in accordance with REACH Annex VIII
column 2. In conclusion, a data waiving is proposed to cover the
hydrolysis endpoint of the registered substance and the non-GLP
stability test is mentioned in the dossier as a supporting study (this
data, performed internally by the lead registrant, cannot be used as a
key or weight of evidence study because the test was performed after
REACh came into force).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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