Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Hydrolysis

Link to relevant study record(s)

Reference

Endpoint:

hydrolysis

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is readily biodegradable

the study does not need to be conducted because the substance is highly insoluble in water

Justification for type of information:

According to Regulation (EC) No. 1907/2006, Column 2 of Annex VIII, hydrolysis testing does not need to be conducted if the substance is readily biodegradable or is highly insoluble in water.  An analogue substance has been determined to be readily biodegradable (i.e. 69% degradation in 29 days, but not meeting the 10-day window, which does not apply to a UVCB); the substance is insoluble in water (i.e., 0.01038 mg/L at 25˚C). Therefore, hydrolysis testing is waived.  

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Description of key information

According to Regulation (EC) No. 1907/2006, Column 2 of Annex VIII, hydrolysis testing does not need to be conducted if the substance is readily biodegradable or is highly insoluble in water.  An analogue substance has been determined to be readily biodegradable (i.e. 69% degradation in 29 days, but not meeting the 10-day window, which does not apply to a UVCB); the substance is insoluble in water (i.e., 0.01038 mg/L at 25˚C). Therefore, hydrolysis testing is waived.