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Hydrolysis

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Waiver: 
The determination of the hydrolysis as a function of pH of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate is scientifically unjustified.
REACh-Regulation No. 1907/2006, Annex VIII, Sect. 9.2.2.1, Col. 2, states as follows:
“9.2.2.1. Hydrolysis as a function of pH:
The study does not need to be conducted if:
- the substance is readily biodegradable, or
- the substance is highly insoluble in water.”
The water solubility determination was performed according to column eluation method (OECD guideline 105). The water solubility of the 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate amounts to 2.5 mg/L +/- 0.08 mg/L at T = 20.0°C +/- 0.1°C.
Thus, determination of the hydrolysis as a function of pH of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate is scientifically unjustified and not required under REACH.
Furthermore, EPIWIN (v. 4.00) software predicted no hydrolysis for the structure of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate.

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